Products

Medical device regulation in Europe is something of a moving target at the moment. Not for much longer though as the pencil pushers are heading us towards a PMA-mimetic system. Just as the FDA is softening its stance. We discuss.

Vascular device specialist AngioDynamics, has received FDA 510(k) clearance for the Xcela Plus Port family through its Navilyst company.

St. Jude Medical, Inc. has gained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI™ Pacemaker and the Tendril MRI™ lead.

Artificial Vital Organs and Medical Bionics Market is Expected to Reach USD 32.3 Billion Globally in 2018: Transparency Market Research … continue reading “Artificial Vital Organs and Medical Bionics Market to Reach USD 32.3 Bn in 2018”

Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories. These have been wrapped up into one Device Alert by the UK’s MHRA regulatory authority.

The U.S. FDA has cleared for marketing Rhythmlink’s Disposable MR Conditional Cup Electrodes, the first of a kind to be formally authorized for use.

Pacing and remote monitoring technology company Biotronik has announced the European market launch of its Ilesto 7 Series. Ilesto 7 … continue reading “EU Market Sees Launch Of World’s First MR Approved DF4 ICD/CRT-D System”

Edwards Lifesciences Corporation, is trumpeting the news that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the country’s first commercially available transcatheter aortic heart valve.

Medtronic, Inc. has announced the first patient enrollments in the U.S. Overnight Closed Loop Study, a key feasibility trial to begin the commercialization path for a third-generation, fully automated artificial pancreas system for people with diabetes.

St.Jude Medical, Inc. has received CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator.

ZipLine Medical’s core platform, which it calls PRELOC™, is a noninvasive surgical skin closure designed to provide a suture-like outcome at the speed of staples. The company says the technique is simple, the device easy-to-learn and easy-to-use.

EndoChoice has announced the FDA clearance of its clever Fuse endoscope system, which it claims allows doctors to see around … continue reading “Newly Cleared 3 Camera “Fuse” System Reduces Adenoma ‘Miss Rate’ During Colonoscopy”

CryoLife, Inc. has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the US FDA. PerClot is an absorbable polysaccharide hemostat, intended for adjunctive use in surgical procedures when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical.

Abyrx, Inc., a privately-held therapeutic device company, has announced the US FDA Clearance of its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the country. The company says this is new product shows it’s offering a vertically integrated product strategy.

ulrich medical USA, Inc., has announced the U.S. market release of rectangular lateral endplates for the obelisc Vertebral Body Replacement System, which is a spinal implant device used in complex spine surgery for trauma/tumor applications.

Brandon Medical has launched a brand new, efficient LED examination light. The Coolview-Eco™ examination light is a state-of-the-art economical examination light perfectly suited for consulting rooms, GP treatment rooms, ICU and A & E.