Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Bard announces $500M buyback
C.R. Bard (NYSE:BCR) said it plans to buy back as much as $500 million worth of its own stock, having spent all but $30 million of a prior share repurchasing plan also worth half a billion.
Companies often buy back their stock when they believe the market is undervaluing share prices, in an effort to raise the price. Read more
2. Cardiovascular Systems launches COAST heart disease study
Minnesota-based Cardiovascular Systems enrolled the 1st patient in its new COAST clinical trial, examining outcomes in patients treated with the company’s micro crown Orbital Atherectomy System.
The 2nd-generation device helps surgeons treat severely calcified coronary lesions in patients with difficult-to-treat cases of coronary artery disease, helping to deliver stents to the affected blood areas. Read more
1. FDA details plan to improve medical device arm
The FDA yesterday detailed a plan to overhaul procedures at its medical device arm, the Center for Devices & Radiological Health, based on recommendations from an outside auditor’s report last year.
The FDA said it will implement a 2-stage process to address the 4 main recommendations of the report consultants Booz Allen Hamilton issued late last year. If the FDA wants to meet the promises it made during the latest round of medtech user fee negotiations, the firm advised, it needs to establish more consistency in decision-making, ramp up its training programs and address quality management issues to make the review process more transparent and standardized for reviewers and the companies undergoing review. Read more
