C.R. Bard (NYSE:BCR) said its application for pre-market approval of the Lutonix drug-eluting balloon is complete now that the final module has been filed with the FDA.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Avedro wins FDA priority review
Avedro said the FDA granted priority review to the new drug application for its riboflavin ophthalmic solution used with its KXL system.
The priority review for the Waltham, Mass.-based medical device company draws Avedro closer to treating keratoconus and corneal ectasia. Keratoconus is a potentially blinding disease, for which limited therapeutic treatment is available in the US. Corneal ectasia is a rare outcome of refractive surgery but is a progressive condition that is difficult to manage, according to a press release.
Sorin scores CE Mark for sutureless heart valve
Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for the XL version of its Perceval sutureless aortic valve.
Milan-based Sorin said the new approval is for treating patients with annulus sizes ranging from 19 mm to 27 mm using the Perceval device.
Boston Scientific wins FDA approval for Promus Premier stent
Boston Scientific (NYSE:BSX) said the FDA granted pre-market approval for its next-generation coronary stent, the Promus Premier.
Natick, Mass.-based Boston Scientific said it plans an immediate release for the Promus Premier, a drug-eluting stent made of a platinum-chromium alloy coated with everolimus.
CMS proposes cardiac rehab for patients with chronic heart disease
Medicare regulators issued a new Proposed Decision Memo, offering expanded coverage for cardiac rehabilitation services for certain patients with heart failure.
The federal agency opened up its traditional public commenting period, soliciting suggestions and perspectives on cardiac rehabilitation, a post-heart-attack regimen of exercise, behavioral and lifestyle modification, health education and counseling.
Kinetic Concepts wins FDA OK for new wound therapy device
Kinetic Concepts Inc. said it won 510(k) clearance from the FDA for a new negative-pressure wound therapy device, the V.A.C.Via, saying it plans to have it on the market in early December.
The V.A.C.Via is a portable wound care system featuring a diaphragm pump for faster draw down, longer battery life and a higher leak rate threshold, according to a press release.
Fenwal lands 510(k) clearance for Alyx blood collection software
Fenwal Inc. said it landed 510(k) clearance from the FDA for a new version of software for its Alyx blood collection system.
Sorin wins CE Mark for stentless heart valve
Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for its Solo Smart heart valve, designed to replace the aortic valve without leaving a stent in place.
‘Software is not a medical device’: FDA medtech chief battles for control of mHealth
The conversation got a bit heated this week as the House Energy & Commerce Committee’s subcommittee on Health sparred with FDA medical device chief Jeffrey Shuren over regulation of mobile medical and healthcare applications.
GE Healthcare lands FDA approval for Optison contrast agent
GE Healthcare (NYSE:GE) said it received pre-market approval from the FDA to begin in-house manufacturing of its Optison imaging agent.
Optison (or Perflutren Protein-Type A Microspheres Injectable Suspension) is a contrast agent designed to improve visualization of the heart’s left ventricle.
Cohera completes PMA application for surgical adhesive
Cohera Medical announced that it submitted the 4th and final module of its FDA pre-market approval application for its TissuGlu surgical adhesive.
The 4th module is comprised of data from the Pittsburgh based-company’s ‘No Drain’ study, in which the adhesive was proven to be a “clinically superior alternative to closed-suction drains for fluid management in large flap procedures,” according to the press release.