MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Medtech approvals: FDA releases January 2014 PMAs

Medtech approvals: FDA releases January 2014 PMAs

By

FDA logo

Summary of PMA Originals & Supplements Approved 
Originals: 2 
Supplements: 43

Summary of PMA Originals Under Review 
Total Under Review: 52 
Total Active: 23 
Total On Hold: 29

Summary of PMA Supplements Under Review 
Total Under Review: 582 
Total Active: 394 
Total On Hold: 188

Summary of All PMA Submissions Received
Originals: 0 
Supplements: 54

Summary of PMA Supplement PMA Approval/Denial Decision Times 
Number of Approvals: 43 
Number of Denials: 0 
Average Days Fr Receipt to Decision (Total Time): 185 
FDA Time: 123.9 Days MFR Time: 61.1 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P130004
1/8/14		 ReSure® Sealant Ocular Therapeutix, Inc.
Bedford, MA
01730		 Approval for the ReSure® Sealant. This device is indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults.
P130021
1/17/14		 Medtronic CoreValve™ System (MCS): Transcatheter Aortic Valve (TAV), Models MCS-P4-23-AOA (23 mm; CoreValve™ Evolut™), MCS-P3-26-AOA (26 mm), MCS-P3-29-AOA (29 mm), and MCS-P3-31-AOA (31 mm); Delivery Catheter System (DCS), Models DCS-C4-18FR and DCS-C4-18FR-23; and Compression Loading System (CLS), Model CLS-3000-18FR Medtronic CoreValve, LLC
Santa Rosa, CA 95403		 Approval for the Medtronic CoreValve™ System. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ≥50% at 30 days).

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830055/S138
1/22/14
135-Day		 LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN 46581		 Approval for changes to device identifiers and part identification verification processes.
P860004/S184
1/8/14
180-Day		 Clinician Programmer, Telemetry Head, Synchromed III Implantable Programmable Infusion Pump, Synchromed II Implantable Programmable Infusion Pump Medtronic, Inc.
Minneapolis, MN
55432		 Approval for the release of a Clinical Summary for Synchromed II Clinical Accuracy.
P860057/S116
1/24/14
180-Day		 Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis Edwards Lifesciences, LLC.
Irvine, CA 92614		 Approval of the post-approval study protocol.
P890003/S290
1/22/14
Real-Time		 CapSure VDD-2 Leads Medtronic, Inc.
Mounds View, MN 
55112		 Approval for use of new silicone insulation tubing materials.
P890055/S053
1/22/14
Special		 MedStream™ Programmable Infusion System; MedStream™ Control Unit; MedStream™ Refill Kit; MedStream™ Bolus Kit; CODMAN® Operating Room Prep Kit Codman & Shurtleff, Incorporated
325 Paramount Drive,
Raynham, MA 02767		 Approval for addition of a 100% inspection to verify the Use by Date on the labels of the MedStream Implantable Infusion Pump System.
P910001/S065
1/14/14
180-Day		 CVX-300 4.0 and CVX-300 4.0P Excimer Laser System Spectranetics Corporation
Colorado Springs, CO 
80921		 Approval for new circuitry and optical components to improve control of the regulated energy output of the CVX-300 laser generator.
P920015/S122
1/22/14
Real-Time		 Lead Adaptor Medtronic, Inc.
Mounds View, MN 
55112		 Approval for use of new silicone insulation tubing materials.
P950005/S047
1/22/14
Real-Time		 Celsius FLTR Bi-directional Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for manufacturing and design changes to the catheter tip.
P960043/S083
1/16/14
135-Day		 Perclose ProGlide®/Perclose AT® Suture Mediated Closure Systems and Snared Knot Pusher Abbott Vascular Inc.
Santa Clara, CA 95054		 Approval for the use of an internal facility as an additional supplier of three extruded components.
P970029/S025
1/28/14
180-Day		 Holmium Laser System Fiber Optic Delivery System Handpiece Cardiogenesis Corporation
Kennesaw, GA 30144		 Approval of the post-approval study protocol.
P970051/S094
1/21/14
180-Day		 Nucleus Cochlear Implant System: Cochlear Integrity Test System Cochlear Americas
Centenial, CO 80111		 Approval for the Cochlear Integrity Test System (CITS).
P980022/S133
1/15/14
180-Day		 Paradigm Real-Time System, Paradigm Real-Time Revel System Medtronic MiniMed
Northridge, CA 91325		 Approval for the reduction of keypad button (dome) sizes, new keypad overlay supplier (Bergquist), and keypad/ overlay/ case assembly process for the Paradigm REAL-Time Insulin Pumps (Models: MMT-522, MMT-522K, MMT-722, MMT-722K and Paradigm REAL-Time Revel Insulin Pumps (Models: MMT-523, MMT-523K, MMT-723, and MMT-723K) that are components of the Paradigm REAL-Time and Paradigm REAL-Time Revel Systems, respectively.
P980023/S054
1/17/14
135-Day		 Linox, Linoxsmart, Vigila, and Volta ICD leads Biotronik
Lake Oswega, OR 
97035		 Approval for an alternate supplier for shock coils used in the subject leads.
P000025/S072
1/10/14
135-Day		 COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI100) MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck – Fürstenweg, Austria
77a		 Approval for an alternate welding process.
P010005/S007
1/29/14
180-Day		 ProstaLund CoreTherm® Accessories for Small Prostates CoreTherm Catheter Short (CA804120); Microwave Antenna Short (AN806101); and lntraprostatic Temperature Probe Short (IP807101) ProstaLund Operations AB
Uppsala, Sweden
SE-751 06		 Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. The device, as modified, will be marketed under the trade name CoreTherm® Accessories for Small Prostates and is indicated for use together with ProstaLund CoreTherm® /SE in patients with glands size 20-50g and with a prostate length ≥25 mm.
P010068/S036
1/22/14
Real-Time		 Celsius FLTR Uni-directional Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765		 Approval for manufacturing and design changes to the catheter tip.
P030027/S007
1/3/14
135-Day		 Ceramic TRANSCEND® Articulation System Wright Medical Technology, Inc.
Arlington, TN 38002		 Approval for changing the incoming inspection process of components from the supplier.
P030052/S012
1/24/14
180-Day		 UroVysion Bladder Cancer Kit Abbott Molecular, Inc.
Des Plaines, IL 60018		 Approval for a manufacturing site located at Leica Biosystems in Solon Mills, Illinois.
P040002/S044
1/24/14
Real-Time		 AFX Endovascular AAA System with Vela Proximal Endograft Delivery System Endologix, Inc.
Irvine, CA 92618		 Approval for dimensional modification of the inner core of the AFX Vela Proximal Endograft Delivery System.
P040045/S041
1/16/14
180-Day		 VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256		 Approval for a change in the viscosity specification from 120-170 cps to 100-170 cps for the reactive monomer mix.
P050007/S031
1/16/14
135-Day		 StarClose SE® Vascular Closure System Abbott Vascular Inc.
Santa Clara, CA 95054		 Approval for the use of an internal facility as an additional supplier of three extruded components.
P050023/S073
1/17/14
Real-Time		 Lumax 300 and 500 Families of ICD’s and CRT-D’s Biotronik, Inc.
Lake Oswego, OR 
97035		 Approval for a modification of the land pad geometry for the high voltage diodes on the substrate.
P050044/S027
1/27/14
135-Day		 Vitagel RT Surgical Hemostat (Vitagel RT3 Surgical Hemostat) Stryker Orthobiologics
Malvern, PA 19355		 Approval of the transfer of sterility testing of Vitagel RT3 filled syringes inhouse.
P060008/S107
1/21/14
180-Day		 Drug-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 
55311		 Approval of the post-approval study protocol.
P060029/S005
1/17/14
180-Day		 Ethicon OMNEX Surgical Sealant Ethicon, Inc.
Somerville, NJ 08876		 Approval for a manufacturing site located at Ethicon, Inc., in Cornelia, Georgia.
P070014/S041
1/22/14
Special		 LifeStent Vascular Stent System C.R. Bard, Inc.
Tempe, AZ 85281		 Approval for an additional labeling verification inspection method for the device packaging.
P080007/S019
1/22/14
Special		 E-Luminexx Vascular Stent System C.R. Bard, Inc.
Tempe, AZ 85281		 Approval for an additional labeling verification inspection method for the device packaging.
P090006/S009
1/22/14
135-Day		 Complete SE Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Approval for multiple stent processing changes for the Complete SE Vascular Stent System.
P100009/S002
1/28/14
180-Day		 Mitral Valve Repair and Clip Delivery Systems (MitraClip®) Abbott Vascular, Inc.
Menlo Park, CA 94025		 Approval of the post-approval study protocol.
P100014/S009
1/14/14
180-Day		 Solesta Salix Pharmaceuticals, Inc.
Raleigh, NC 
27615		 Approval for the revision of the prescribing information to include 24 and 26 month data.
P100021/S027
1/24/14
180-Day		 Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403		 Approval of the post-approval study protocol.
P100040/S012
1/22/14
Panel-Track		 Valiant Thoracic Stent Graft with Captivia Delivery System Medtronic Vascular
Santa Rosa, CA 95403		 Approval for the Valiant Thoracic Stent Graft with Captivia Delivery System (Valiant Captivia). This device is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the appropriate anatomy including: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices or accessories; nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers), or 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 (fusiform and saccular aneurysms/ penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.
P100040/S013
1/7/14
Real-Time		 Valiant Thoracic Stent Graft System with Captivia Delivery System Medtronic Vascular
Santa Rosa, CA 95403		 Approval for a product line extension consisting of the addition of 11 Valiant Freeflo Tapered Stent Grafts. The device, as modified, will be marketed under the trade name Valiant Thoracic Stent Graft System with Captivia Delivery System and is indicated for the endovascular repair of isolated lesions (excluding dissections) of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers) or 18 mm to 44 mm (blunt traumatic aortic injuries); and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm.
P100041/S037
1/31/14
135-Day		 SAPIEN™ Transcatheter Heat Valve and Transfemoral Accessories Edwards Lifesciences, LLC
Irvine, CA 92614		 Approval for a change in material to the mandrels used as manufacturing aids for the delivery system.
P100044/S012
1/31/14
180-Day		 Propel Mini Sinus Implant Intersect ENT
Menlo Park, CA 94025		 Approval to revise the release rate specification.
P100044/S013
1/9/14
Real-Time		 Propel® Mini Sinus Implant Intersect ENT
Menlo Park, CA 94025		 Approval for a design modification to the Delivery System Accessory component of the previously approved Propel Mini Sinus Implant.
P110012/S004
1/24/14
180-Day		 Vysis ALK Break Apart FISH Probe Kit Abbott Molecular, Inc.
Des Plaines, IL 60018		 Approval for a manufacturing site located at Leica Biosystems in Solon Mills, Illinois.
P110013/S028
1/30/14
180-Day		 Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic, Inc.
Santa Rosa, CA 95403		 Approval for modifications to the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) to include updated clinical information.
P110019/S055
1/14/14
Real-Time		 XIENCE Xpedition Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA 92589		 Approval for a labeling change for the XIENCE Xpedition , XIENCE Xpedition SV, and the XIENCE Xpedition LL Everolimus Eluting Coronary Stent System for the OTW platform. This labeling change requested a shelf life extension from 12 to 24 months.
P110019/S058
1/7/14
180-Day		 XIENCE Xpedition Stent System Abbott Vascular
Temecula, CA 92589		 Approval for a manufacturing site located in North Brunswick, New Jersey.
P110021/S024
1/31/14		 SAPIEN™ Transcatheter Heart Valve and Transfemoral and Transapical Accessories Edwards Lifesciences, LLC
Irvine, CA 92614		 Approval for a change in material to the mandrels used as manufacturing aids for the delivery system.
P110028/S011
1/16/14
135-Day		 Absolute Pro® Vascular Self-Expanding Stent System Abbott Vascular
Temecula, CA 92591		 Approval for a change to the stent sub-assembly cleaning process that occurs prior to the electropolish process.
P110042/S020
1/31/14
180-Day		 Subcutaneous Implantable Defibrillator S-ICD System Cameron Health, Inc.
San Clemente, CA 
92673		 Approval for a new battery supplier for the SQ-RX Model 1010 Implantable Pulse Generator.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P800002/S020
1/14/14		 Avitene Microfibrillar Collagen Hemostat Product Davol, Inc.
Warwick, RI 
02886		 Add a new supplier for the blister tray used for the Avitene Microfibrillar Collagen Hemostat-Endo Avitene product.
P810006/S050
1/17/14		 Collastat Absorbable Collagen Hemostatic Sponge Integra LifeSciences Corporation
Plainsboro, NJ
08536		 Change to introduce an alternate test method for bacterial endotoxin in collagen products.
P830061/S102
1/8/14		 CAPSURE Lead Medtronic, Inc.
Mounds View, MN 
55112		 Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P820003/S126
1/16/14		 Single and Dual Temporary Pacemakers Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P830061/S104
1/16/14		 CapSure Sense, CapSure SP, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+ Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P830061/S105
1/16/14		 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead Medtronic CRDM
Mounds View MN
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P840001/S259
1/22/14		 SCS Accessories; SCS Extensions; Hinged 2×4 Surgical Lead; Vectris SureScan 1×8 Leads; Pisces Leads; Resume Leads; Lead Revision Kits; Specify Leads; Trialing System Screening Cable; Vectris 1×8 trialing Leads Medtronic Neuromodulation
Minneapolis, MN
55432		 Manufacturing change associated with incoming inspection activities.
P840062/S037
1/17/14		 CollaCote and CollaTape Absorbable Collagen Wound Dressings for Dental Surgery Integra LifeSciences Corporation
Plainsboro, NJ
08536		 Change to introduce an alternate test method for bacterial endotoxin in collagen products.
P850010/S049
1/17/14		 Helistat Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ
08536		 Change to introduce an alternate test method for bacterial endotoxin in collagen products.
P850089/S104
1/16/14		 CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Vitatron impulse II Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P850089/S105
1/16/14		 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead Medtronic CRDM
Mounds View MN
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P860057/S117
1/23/14		 Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA 
92614		 Change in the polyester cloth manufacturing aid.
P870056/S064
1/23/14		 Carpentier-Edwards Porcine Aortic and Mitral Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA 
92614		 Change in the polyester cloth manufacturing aid.
P870077/S058
1/23/14		 Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring; Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA 
92614		 Change in the polyester cloth manufacturing aid.
P890003/S294
1/9/14		 MyCareLink Patient Monitor, MyCareLink Reader FRU Medtronic, Inc.
Mounds View, MN 
55112		 Process change for the MyCareLink Monitor Solder Process.
P890003/S298
1/16/14		 CapSure Lead Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P890003/S300
1/16/14		 MyCareLink Patient Monitor and Reader FRU Medtronic CRDM
Mounds View, MN 
55112		 Change in the test equipment/test method used in the quality control inspection process of the printed circuit board assemblies used in the MyCareLink Patient Monitor.
P890003/S301
1/16/14		 CapSure Lead Medtronic CRDM
Mounds View MN
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P890055/S052
1/15/14		 MedStream Programmable Infusion System Codman & Shurtleff, Inc.
Raynham, MA 02767		 New steam sterilizer.
P900056/S130
1/30/14		 Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN 
55311		 Change to the long drive laser welder equipment used in the RotaLink long drive sub-assembly line.
P900061/S126
1/16/14		 Epicardial Patch Lead Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P910001/S069
1/14/14		 ELCA Coronary Atherectomy Catheters Spectranetics Corporation
Colorado Springs, CO 
80921		 Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring.
P920015/S127
1/16/14		 Sprint Quattro, Transvene CS/SVC Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P920015/S128
1/16/14		 Sprint Quattro Lead, HV Splitter/Adaptor Kit Medtronic CRDM
Mounds View MN
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P930014/S070
1/9/14		 AcrySof Intraocular Lens Alcon Research, Ltd.
Fort Worth, TX 76134		 Use of a new aberrometer.
P930014/S071
1/13/14		 AcrySof Monofocal Posterior Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX 76134		 Reduce frequency of a manufacturing inspection from a 100% inspection rate to a sample-based inspection plan for devices within a lot.
P930029/S040
1/16/14		 RF Marinr MC (7fr), RF Marinr (5fr), RF Contactr, RF Conductr, Rf, Enhancr II Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P930039/S098
1/8/14		 CAPSUREFIX Novus Lead Medtronic, Inc.
Mounds View, MN 
55112		 Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P930039/S101
1/16/14		 CapSure Fix, CapSureFix Novus, SureFix, Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P930039/S102
1/16/14		 CapSureFix Novus Lead, Vitatron Crystalline Lead Medtronic CRDM
Mounds View MN
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P950005/S049
1/24/14		 Celsius, Celsius RMT, EZ Steer Non-Temp sensing Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765		 Change in the sterilization release method for Biosense Webster catheters and cables.
P950024/S056
1/16/14		 CapSure Epicardial Pacing Lead Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P950024/S057
1/16/14		 CapSure Epicardial Pacing Lead Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P950037/S133
1/6/14		 Selox ST 53, Selox ST 60, Selox JT 45,Selox JT 53, Setrox S 45, Setrox S 53, Setrox S 60, Dextrus 4135, Dextrus 4136, Detrus 4137 Pacing Leads Biotronik, Inc.
Lake Oswego, OR 
97035		 Two additional injection molding tools used to manufacture the silicone sleeves of the pacemaker leads.
P950039/S027
1/29/14		 ThinPrep Processor 2000/3000 Hologic, Inc.
Marlborough, MA 
01752		 Addition of a specification on minimum cell transfer requirements for the ThinPrep Microscope Slides.
P960009/S187
1/22/14		 DBS Accessories; DBS Extensions; DBS Leads; DBS Screening Systems Medtronic Neuromodulation
Minneapolis, MN
55432		 Manufacturing change associated with incoming inspection activities.
P960042/S047
1/14/14		 Spectranetics Laser Sheaths SLS Spectranetics Corporation
Colorado Springs, CO 
80921		 Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring.
P960043/S085
1/29/14		 Perclose Proglide® and Perclose AT® Suture Mediated Closure Systems Abbott Vascular Inc.
Santa Clara, CA 95054		 Change to the joint tensile testing process.
P960043/S086
1/30/14		 Perclose ProGlide Suture Mediated Closure Device and Perclose AT 6F Suture Mediated Closure System Abbott Vascular Inc.
Santa Clara, CA 95054		 Additional testing apparatus and procedure be included in the functional testing performed on the Gated Suture Trimmer.
P960058/S105
1/8/14		 HiResolution Bionic Ear System Advanced Bionics
Sylmar, CA 
91342		 Use of a new sterilization cycle.
P970003/S167
1/2/14		 Cyberonics VNS Therapy System Cyberonics, Inc.
Houston, TX 
77058		 Replace the capacitor used in the assembly of the printed circuit boards for the Programming Wand.
P970004/S166
1/22/14		 SNS Urinary Extensions; SNS Urinary Leads Medtronic Neuromodulation
Minneapolis, MN
55432		 Manufacturing change associated with incoming inspection activities.
P970012/S094
1/16/14		 Application Software, Remote Assistant Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
N970012/S098
1/2/14		 AMS 700 Inflatable Penile Prosthesis American Medical Systems, Inc.
Minnetonka, MN 55343		 Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment.
P980016/S453
1/16/14		 Evera S DR/VR ICD, Evera XT DR/VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICDs Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P980035/S356
1/8/14		 ADAPTA, VERSA, SENSIA Implantable Pulse Generators Medtronic, Inc.
Mounds View, MN 
55112		 Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P980035/S359
1/16/14		 Adapta, Versa, Sensia IPG, Advisa DR/DR MRI IPG, Relia IPG Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P980035/S361
1/22/14		 Adapta, Versa, Sensia IPG; Advisa DR IPG;. Advisa DR MRI IPG; Relia IPG Medtronic, Inc.
Mounds View, MN 
55112		 New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.
P980035/S362
1/16/14		 Advisa DR IPG, Advisa DR MRI IPG Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P980044/S017
1/14/14		 SUPARTZ Joint Fluid Therapy Seikagaku Corporation
Tokyo, Japan
100-0005		 Contract laboratory change.
P980050/S089
1/16/14		 Transvene CS/SVC Lead Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P980050/S090
1/16/14		 Transvene CS/SVC Lead Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P990001/S116
1/16/14		 Vita VVIR IPG Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P990025/S039
1/24/14		 NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BWI Cables Biosense Webster, Inc.
Diamond Bar, CA
91765		 Change in the sterilization release method for Biosense Webster catheters and cables.
P990038/S019
1/10/14		 ETI-MAK-2 PLUS and HBsAg Confirmatory Test DiaSorin Inc.
Stillwater, MN 55082		 Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990041/S018
1/10/14		 ETI-AB-EBK PLUS DiaSorin Inc.
Stillwater, MN 55082		 Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990042/S015
1/10/14		 ETI-AB-AUK PLUS DiaSorin Inc.
Stillwater, MN 55082		 Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990043/S019
1/10/14		 ETI-EBK PLUS DiaSorin Inc.
Stillwater, MN 55082		 Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990044/S016
1/10/14		 ETI-CORE-IGMK PLUS DiaSorin Inc.
Stillwater, MN 55082		 Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990045/S016
1/10/14		 ETI-AB-COREK PLUS DiaSorin Inc.
Stillwater, MN 55082		 Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990046/S037
1/24/14		 Open Pivot Heart Valve and Aortic Valve Graft Medtronic Inc.
CardioVascular
Mounds View, MN 
55112		 Alternative to batch testing for bacterial endotoxin testing (BET).
P990071/S025
1/24/14		 RF Generator and Accessories/Accessory Cables Biosense Webster, Inc.
Diamond Bar, CA
91765		 Change in the sterilization release method for Biosense Webster catheters and cables.
P990081/S025
1/22/14		 PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ 
85755		 Addition of a new supplier for PCBAs (Printed Circuit Board Assemblies) used in the manufacture of the BenchMark ULTRA Instrument.
P990081/S026
1/23/14		 PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ 
85755		 Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument.
P000006/S035
1/17/14		 Titan Inflatable Penile Prosthesis Coloplast Corp
Minneapolis, MN 
55411		 Change to the mold used in the manufacture of the connector sleeve.
P000012/S047
1/9/14		 COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0 Roche Molecular Systems, Inc.
Pleasanton, CA 94588		 Change to discontinue chemical testing for potassium concentration in master mixes.
P000025/S074
1/17/14		 COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI100) MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck – Fürstenweg 77a
Austria
A-6020		 Changes in the vacuum bake-out process and the preparation of in-process test samples.
P000046/S021
1/24/14		 Staarvisc, Optivisc, and Anikavisc Sodim Hyaluronate Anika Therapeutics, Inc.
Bedford, MA 01730		 Change to the manufacturing process with regard to the device’s packaging.
P000046/S022
1/23/14		 Staarvisc II, Shellgel Anika Therapeutics, Inc.
Bedford, MA 01730		 Addition of a new cannula supplier.
P000053/S049
1/2/14		 AMS 800 Urinary Control American Medical Systems, Inc.
Minnetonka, MN 55343		 Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment.
P010015/S228
1/16/14		 Attain Bipolar OTW Lead, Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P010015/S230
1/22/14		 Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 
55112		 New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.
P010015/S231
1/16/14		 Attain Bipolar OTW Lead, Consulta CRT-P, Left Ventricular Pacing Lead, Syncra CRT-P Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P010030/S047
1/22/14		 LifeVest Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA 15238		 New supplier for the therapy electrode gas generator base and therapy electrode gas generator enclosure cover.
P010031/S415
1/16/14		 Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta XT CRT-D , Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P010033/S023
1/31/14		 QuantiFERON®-TB Gold Cellestis Incorporated
Valencia, CA 91355		 Changes to incorporate new branding in the labeling, tighten an in-process QC specification for the blood collection tubes, and add steps to a raw material acceptance procedure.
P010041/S047
1/23/14		 Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA 
92614		 Change in the polyester cloth manufacturing aid.
P010047/S033
1/27/14		 Progel Pleural Air Leak Sealant Neomend Inc.
Irvine, CA 
92618		 Addition of a second source component supplier.
P010068/S038
1/24/14		 Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765		 Change in the sterilization release method for Biosense Webster catheters and cables.
P020004/S089
1/17/14		 GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates, Inc.
Flagstaff, AZ 
86005		 Alternate PTFE resin.
P020009/S114
1/29/14		 Express2 Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 
55311		 Remove the metals content load test used for the monitoring of electropolishing solutions.
P020055/S013
1/23/14		 Pathway Anti-c-KIT (9.7) Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ 
85755		 Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument.
P030009/S073
1/14/14		 Integrity Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P030017/S187
1/22/14		 Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Canyon Loop
Valencia, CA 91355		 Add an alternate qualified supplier for the printed circuit board assembly.
P030017/S188
1/22/14		 Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Canyon Loop
Valencia, CA 91355		 Add an alternate qualified supplier for the feedthrough component.
P030022/S028
1/13/14		 Reflection Ceramic Acetabular Hip System Smith & Nephew, Incorporated
Memphis, TN 38116		 Change to a different detergent chelating agent.
P030022/S029
1/13/14		 Reflection Ceramic Acetabular Hip System (RCHS) Smith & Nephew, Incorporated
Memphis, TN 38116		 Add new manufacturing equipment.
P030031/S058
1/24/14		 Celsius ThermoCool, Celsius RMT ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765		 Change in the sterilization release method for Biosense Webster catheters and cables.
P030036/S068
1/16/14		 Select Secure Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P030036/S069
1/16/14		 SelectSecure Lead Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P030050/S019
1/23/14		 SCULPTRA and SCULPTRA AESTHETIC Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807		 Changes to the sieving yield range and a modification of the stirring system for clogging test.
P040016/S120
1/29/14		 VeriFLEX (Liberte) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 
55311		 Remove the metals content load test used for the monitoring of electropolishing solutions.
P040020/S052
1/13/14		 AcrySof ReSTOR Multifocal Posterior Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX 76134		 Reduce frequency of a manufacturing inspection from a 100% inspection rate to a sample-based inspection plan for devices within a lot.
P040036/S041
1/24/14		 NaviStar-, Navistar RMT-, EZ Steer- ThermoCool Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765		 Change in the sterilization release method for Biosense Webster catheters and cables.
P040044/S050
1/24/14		 Mynx Vascular Closure Device Product Family, MynxGrip and MynxAce Access Closure Inc.
Santa Clara, CA 95054		 Changes to the Hydrogel drying process.
P050028/S038
1/9/14		 COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0 Roche Molecular Systems, Inc.
Pleasanton, CA 94588		 Change to discontinue chemical testing for potassium concentration in master mixes.
P050028/S039
1/23/14		 COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/COBAS® TaqMan® HBV Test version 2.0 Roche Molecular Systems, Inc.
Pleasanton, CA 94588		 Change to discontinue in-process testing for pH and visual inspection for a vialed component.
P050034/S012
1/15/14		 Implantable Miniature Telescope VisionCare Ophthalmic Technologies
Petah Tikva, 
Israel 
49130		 Possibility of rework and retesting activities.
P050051/S025
1/9/14		 ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL 60064		 Change to the purification process for antigens used in the manufacture of the ARCHITECT AUSAB assay.
P060006/S053
1/29/14		 Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 
55311		 Remove the metals content load test used for the monitoring of electropolishing solutions.
P060030/S038
1/9/14		 COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System Roche Molecular Systems, Inc.
Pleasanton, CA 94588		 Change to discontinue chemical testing for potassium concentration in master mixes.
P060033/S085
1/14/14		 Endeavor Sprint Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P060039/S054
1/16/14		 Attain StarFix Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P060039/S055
1/16/14		 Attain StarFix Lead Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P070004/S007
1/8/14		 Sientra Silicone Gel Breast Implants Sientra, Inc.
Santa Barbara, CA 
93117		 Changes to the material of the breast implant molds.
P070015/S118
1/8/14		 XIENCE V Everolimus Eluting Coronary Stent System on both RX (Rapid Exchange) and OTW (Over the Wire) Platforms and XIENCE nano Everolimus Eluting Coronary Stent System on the RX Platform Abbott Vascular
Temecula, CA 92590		 Modifications to the sampling plan for XIENCE final release testing.
P070027/S037
1/14/14		 Talent AAA Stent Graft with Xcelerant Hydro Delivery System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P080006/S064
1/16/14		 Attain Ability Leads Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P080006/S065
1/16/14		 Attain Ability Lead Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P080025/S062
1/22/14		 SNS Bowel Extensions; SNS Bowel Leads Medtronic Neuromodulation
Minneapolis, MN
55432		 Manufacturing change associated with incoming inspection activities.
P090003/S030
1/29/14		 Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 
55311		 Remove the metals content load test used for the monitoring of electropolishing solutions.
P090006/S012
1/14/14		 Complete SE Iliac Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P090013/S121
1/8/14		 CAPSUREFIX MRI Lead Medtronic, Inc.
Mounds View, MN 
55112		 Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P090013/S123
1/16/14		 CapSureFix MRI Lead, Revo MRI IPG Medtronic, Inc.
Mounds View, MN 
55112		 Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P090013/S125
1/22/14		 Revo MRI IPG Medtronic, Inc.
Mounds View, MN 
55112		 New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.
P090013/S126
1/16/14		 CapSureFix MRI Lead, Revo MRI IPG Medtronic CRDM
Mounds View, MN 
55112		 Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P100021/S031
1/14/14		 Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P100026/S007
1/24/14		 NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA
94043		 Implement a new database used to collect and store manufacturing test data.
P100027/S014
1/22/14		 INFORM HER2 Dual ISH DNA Probe Ventana Medical Systems, Inc.
Tucson, AZ 
85755		 Addition of a new supplier for PCBAs (Printed Circuit Board Assemblies) used in the manufacture of the BenchMark ULTRA Instrument.
P100027/S015
1/23/14		 INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ 
85755		 Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument.
P100040/S015
1/14/14		 Valiant Thoracic Stent Graft with the Captivia Delivery System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P110011/S006
1/14/14		 Assurant Cobalt Iliac Balloon-Expandable Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P110013/S032
1/14/14		 Resolute Integrity Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P110019/S059
1/8/14		 XIENCE PRIME (XIENCE PRIME and XIENCE PRIME Long Lengths [LL]) on the RX platform Abbott Vascular
Temecula, CA 92590		 Modifications to the sampling plan for XIENCE final release testing.
P110020/S011
1/9/14		 cobas® 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588		 Change to discontinue chemical testing for potassium concentration in master mixes.
P110040/S002
1/14/14		 Complete SE SFA/PPA Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Change to the bioburden test method.
P110042/S024
1/22/14		 S-ICD® System Cameron Health, Inc.
San Clemente, CA 
92673		 Additional system used in manufacturing operations for the S-ICD® System.
P110042/S025
1/31/14		 S-ICD System Cameron Health, Inc.
San Clemente, CA 
92673		 Use of a two-part epoxy on the high voltage capacitor used in the S-ICD System.

In case you missed it

RSS From Medical Design & Outsourcing

  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]
  • FDA’s breakthrough medical device designations tally nears 700
    Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases. According to recent metrics published by FDA, the agency has issued a total of… […]
  • Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing
    Lifecore Biomedical parent company Landec Corp. (Nasdaq:LNDC) plans to take the subsidiary’s name, leadership and headquarters as its own and sell off food businesses to focus on contract development and manufacturing. Santa Maria, California-based Landec said it will rename itself as Lifecore Biomedical “in the near future” and change its Nasdaq ticker to LFCR. Landec… […]
  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]
  • New implant design prevents scar tissue without drugs, MIT says
    Mechanically inflating and deflating an implantable device for 10 minutes a day prevents immune cells from building the scar tissue that has been a major obstacle for artificial pancreas researchers. That’s according to new findings from a team of MIT engineers who built mechanical deflection into a two-chambered, soft polyurethane device tested on mice. By… […]

Leave a Reply