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Press Release

LifeScience Alley Names Winners for 2014 New Technology Showcase

September 24, 2014 By Brian Johnson Leave a Comment

MINNEAPOLIS, MN – (September 24, 2014) – LifeScience Alley® named 10 companies to this year’s New Technology Showcase, which recognizes groundbreaking advancements in healthcare technology and provides a forum for companies to present new products to the Medical Alley community at the LifeScience Alley conference. Each of the 10 winners will have exhibit space; three of the 10 selected organizations will present during the luncheon plenary session. The conference will take place on November 19 at the Minneapolis Convention Center in Minneapolis. Mayo Clinic has joined as the New Technology Showcase Partner for the third consecutive year.
 

Filed Under: Uncategorized Tagged With: Medical Alley, Press Release

Press Release: St. Jude Medical receives CE Mark approval for pacing lead labeling that will expand patient access to MRI scans

September 22, 2014 By MassDevice Leave a Comment

Press Release: St. Jude Medical receives CE Mark approval for pacing lead labeling that will expand patient access to MRI scans

Filed Under: Cardiac Implants, Implants, News Well Tagged With: Cardiac Rhythm Management, Press Release, stjudemedical

Press Release: NxStage announces FDA clearance of Single Needle Technology

September 18, 2014 By MassDevice Leave a Comment

Press Release: NxStage announces FDA clearance of Single Needle Technology

LAWRENCE, Mass. — 

NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced its single needle technology, OneSite, has received FDA clearance.

Filed Under: News Well, Regulatory/Compliance Tagged With: Dialysis, NxStage Medical Inc., Press Release

Press Release: FDA clears da Vinci system use in benign base of tongue resection procedures

September 18, 2014 By MassDevice

Press Release: FDA clears da Vinci system use in benign base of tongue resection procedures

Filed Under: News Well, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance, Robotics Tagged With: Intuitive Surgical, Press Release

Diabetes: FDA OKs 1st glucose meter with insulin calculator

September 18, 2014 By Arezu Sarvestani

Diabetes: FDA OKs 1st glucose meter with insulin calculator

Biotech titan Roche secured a landmark FDA win with clearance for its Accu-Chek Aviva Expert blood glucose meter, the 1st of its kind with a built-in insulin calculator to help guide patient therapy.

Filed Under: Diabetes, News Well Tagged With: Press Release, Roche, Roche Diabetes Care

Press Release: ACCU-CHEK Aviva Expert, the first and only stand-alone blood glucose meter system with a built-in insulin calculator, is now available

September 18, 2014 By MassDevice Leave a Comment

Press Release: ACCU-CHEK Aviva Expert, the first and only stand-alone blood glucose meter system with a built-in insulin calculator, is now available

Filed Under: News Well Tagged With: Press Release, Roche, Roche Diabetes Care

Press Release: Symetis receives CE Mark approval for transfemoral transcatheter aortic heart valve system

September 12, 2014 By MassDevice Leave a Comment

Press Release: Symetis receives CE Mark approval for transfemoral transcatheter aortic heart valve system

LAUSANNE, SWITZERLAND – Symetis SA, the leading European developer of transcatheter aortic valve implantation (TAVI) systems, announced today the launch of ACURATE neo, its 15F compatible transfemoral TAVI system. Commercial implantations started early September after Symetis received CE Mark approval for ACURATE neo this summer.

Filed Under: News Well, Regulatory/Compliance, Replacement Heart Valves Tagged With: CE Mark, Press Release, Symetis

Sirtex Medical Inc. experiences record growth, expands business into Brazil

September 11, 2014 By MassDevice Leave a Comment

WOBURN, Mass. (September 8, 2014) –– Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited (ASX:SRX), a leading manufacturer of targeted, liver cancer therapies, announced today the expansion of its business in Latin America. Sirtex’s SIR-Spheres® microspheres are now available to treat inoperable liver tumors in Brazil. The first SIR-Spheres microspheres treatments took place the first week of September at Hospital Sirio-Libanes in Sao Paulo. Sirtex received product approval from the Agência Nacional de Vigilância Sanitária (ANVISA) for SIR-Spheres microspheres early in 2014.

Filed Under: Uncategorized Tagged With: Press Release, Sirtex Medical

Press Release: AcuFocus small-aperture IOL receives CE Mark for Europe

September 11, 2014 By MassDevice Leave a Comment

Press Release: AcuFocus Small-Aperture IOL Receives CE Mark for Europe

Irvine, CA – AcuFocus, Inc. (www.acufocus.com), the global leader in small-aperture technology, today announced that its extended depth of focus intraocular lens (IOL), the IC-8™ small aperture IOL, has achieved CE Mark (Conformité Européenne) approval in Europe.  The lens is designed to provide exceptional visual quality across a broad range of vision for presbyopic patients with cataracts.

Filed Under: News Well, Optical/Ophthalmic, Regulatory/Compliance Tagged With: AcuFocus Inc., CE Mark, Press Release

Press Release: Global Kinetics Corporation announces FDA clearance of the Personal KinetiGraph for assessment of Parkinson’s Disease symptoms

September 10, 2014 By MassDevice Leave a Comment

Press Release: Global Kinetics Corporation announces FDA clearance of the Personal KinetiGraph for assessment of Parkinson's Disease symptoms

Filed Under: Digital Health, News Well Tagged With: Digital Health, Global Kinetics Corp., Parkinson's disease, Press Release

Press Release: Cordis Corporation launches INCRAFT AAA stent graft system for treatment of abdominal aortic aneurysms

September 10, 2014 By MassDevice Leave a Comment

Press Release: Cordis Corporation launches INCRAFT AAA stent graft system for treatment of abdominal aortic aneurysms

Filed Under: News Well, Regulatory/Compliance, Stent Grafts, Vascular Tagged With: CE Mark, Cordis Corp., Johnson and Johnson, Press Release

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