7 medtech stories we missed this week: August 11, 2017

August 11, 2017 By Danielle Kirsh Leave a Comment

[Image from unsplash.com]

From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention.

1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant

Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally mature. It is supposed to be used with spinal fixation systems like Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.

2. Life Spine touts first use of TiBow spacer

Life Spine has announced the first clinical use of its TiBow MIS TLIF Expandable Spacer System with Osseo Loc Surface Technology in an Aug. 8 press release. TiBow is designed for in-situ expansion for increased endplate coverage and stability for minimally invasive TLIF and oblique approaches. It gives the surgeon the ability to restore sagittal alignment.

3. Cardiac Science inks deal to supply AEDs to Philadelphia schools

Cardiac Science announced in an Aug. 8 press release that it has reached a deal with the School District of Philadelphia to make automated external defibrillators (AEDs) available in all 220 Philadelphia schools. Philadelphia’s high schools and middle schools already have the Cardiac Science Powerheart G3 and G5 AEDs in place and the elementary schools are set to receive the company’s Powerheart G5 units.

4. ApiFix wins nod in Australia

ApiFix has received TGA certification through its Orthotech Pty. distributor to market the ApiFix system in Australia, according to an Aug. 8 press release. The ApiFix system is designed to treat and correct adolescent idiopathic scoliosis (AIS) using a minimally-invasive surgical approach. The system is a non-fusion spinal implant system that is designed to improve the quality of life of patients who have to have scoliosis surgery.

5. Pentax Medical launches slim linear ultrasound

Pentax Medical announced in an Aug. 9 press release that it has launched its new Slim Linear Ultrasound Endoscope in the U.S. The endoscope features a smaller insertion tube, a smaller distal end and a shorter bending section to help endoscopies see and reach hard-to-access anatomy.

6. Hip Innovation launches clinical trial of novel hip replacement system

Hip Innovation Technology has started its clinical trial to evaluate the effectiveness and safety of the HRS lead hip replacement system, according to an Aug. 9 press release. The clinical study will include 100-120 patients who are scheduled to receive a total hip arthroplasty. The company plans to test effectiveness using clinical radiologic, radiostereometric and patient-reported outcomes. It will measure safety through collecting device-related adverse events. They will also assess the quality of life of each patient.

7. Varian Medical inks distribution deal with Bionix radiation therapy

Varian medical Systems announced in an Aug. 9 press release that it has entered an agreement with Bionix Radiation Therapy to distribute the Bionix brachytherapy applicators in North America. Varian has agreed to market the Bionix Esophageal Application (E-App) and the Anorectal Applicator (AR-1). E-App is a disposable brachytherapy applicator that is designed to treat upper GI cancers. It has five independently operated balloons that help maintain the central position of source catheters in straight and curved anatomy. AR-1 is a disposable brachytherapy applicator that is designed to treat anal and rectal cancers. It allows for exophytic tumors to press closer to a source catheter to deliver a very high dose to the tumor while keeping healthy tissues safe.

Here’s what we missed last week.

RSNA 2019: 7 radiology innovations you need to know
Nearly 53,000 people attended the 2019 Radiological Society of North America annual meeting in Chicago last week. And they heard the same acronym over and over again: AI. Exhibitors at the conference touted their artificial-intelligence-enhanced technology at every turn, claiming to make images clearer, sharper, easier to use and powerful enough to help clinicians make… […]
Employees say Intuitive Surgical, J&J, Stryker best places to work in 2020
Intuitive Surgical (NSDQ:ISRG), Johnson & Johnson (NYSE:JNJ) and Stryker (NYSE:SYK) were recently named as Glassdoor’s employees’s choice of Best Places to Work in 2020. Each year, Glassdoor uses feedback that employees have shared on the website over the past year to compile a list of the best places to work in 2020. Employee reviews provide Glassdoor with insights into job and… […]
Biolase lands 510(k) for dental hygiene laser
Biolase (NSDQ:BIOL) this week announced it has received FDA 510(k) clearance for its Epic Hygiene dental laser. The laser system allows dental hygienists to manage non-surgical periodontitis and increase clinical production. It offers a step-by-step clinical protocol with pocket therapy and perio debridement for easy implementation. Get the full story on our sister site, MassDevice. The […]
Mayo Clinic, W.L. Gore team up on stem cell therapy treatments
Mayo Clinic and W. L. Gore & Associates have announced a partnership to develop implantable cell therapies to treat debilitating conditions with no cure. The for-profit company, Avobis Bio, will combine a patient’s own stem cells with bioabsorbable scaffolds to stimulate the healing of perianal fistulas, painful tunneling wounds that affect patients with Crohn’s disease.… […]
Toray Industries touts polymer optical fiber
Toray Industries said today that its Raytela polymer optical fiber provides for high-quality imaging in the minimally invasive medical device market. Raytela can negotiate tight 9mm radius bends, making it useful for devices used in endoscopy, uretroscopy, ophthalmic surgery and other procedures that require smaller devices that can navigate more tortuous paths than previously available,… […]
Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant
This article has been updated with comments from Medline Industries. People who live about a mile away from a Medline device sterilization plant in Waukegan, Ill. have blood levels of the cancer-causing gas ethylene oxide that are about 50% higher than those who live farther away, according to a report by WebMD and Georgia Health… […]
Glooko gains ISO certification for California, Sweden sites
Diabetes software company Glooko announced today that its Mountain View, Calif., and Gothenburg, Sweden, sites have received joint ISO 13485:2016 certification from accredited certification body Intertek Testing Services. ISO 13485 describes the requirements for comprehensive practices and procedures for the design, development, production and delivery of medical devices, including digital health software. To become ISO… […]
FDA details framework for abbreviated 510(k) medical device review pathway
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are… […]
Drug or device? FDA loses this argument for now
This article has been updated with comments from an attorney for Genus Medical Technologies. A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug. The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the… […]
Greenlight Guru updates change management capabilities of QMS
Greenlight Guru said today that it has added updates to the change management capabilities  of its medical device quality management system (MDQMS). The update was designed to improve traceability and efficiency associated with product and process changes, according to the Indianapolis-based company. It includes advanced workflow efficiencies to identify, assess and track the items affected… […]
Medical device excise tax would reduce R&D spending, report says
The medical device excise tax will reduce research and development spending and impede innovation if reinstated in 2020, according to a report from Minnesota trade group Medical Alley Association. In the report, Medical Alley surveyed its members that will be affected by the return of the tax on Jan. 1, 2020. About 83% of survey respondents… […]