Regulatory

Philips says its newly FDA cleared AlluraClarity system with its powerful ClarityIQ technology provides high quality imaging for a comprehensive range of clinical procedures, achieving excellent visibility at low X-ray dose levels for patients of all sizes.

Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa, has announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark.

Just in case you don’t think the FDA keeps on top of the companies under its watchful eye, take a … continue reading “FDA’s Sleep-Over At Intuitive Yields Troubling Observations”

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.

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.

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.

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.

On May 13, 2013, Endologix, Inc. initiated a recall of AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures. Now this recall has been elevated to FDA Class I status.

FDA clearance for Verasense means it’s the first intraoperative system to market that combines quantifiable limb alignment and soft tissue balancing for surgeons during total knee arthroplasty.