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.
Pavmed dramatically trimmed its pending initial public offering, saying it plans to float 1.2 million shares at $5 apiece for gross proceeds of $6 million.
That’s a far cry from the $23 million top end Pavmed listed when it registered the IPO last May. Pavmed is developing devices in 5 areas, according to its IPO registration: The PortIO long-term implantable vascular access device; the Caldus line disposable tissue ablation devices, including renal denervation for hypertension; the CarpX percutaneous device to treat carpal tunnel syndrome; the NextCath self-anchoring short-term catheter; and the NextFlo disposable infusion pump. Read more
A federal judge approved the $42.5 million settlement of a class-action securities lawsuit brought against Baxter over the recall of its Colleague infusion pump and a too-rosy assessment of its plasma business.
The lead plaintiff in the case, the National Elevator Industry Pension Fund, alleged in September 2010 that Deerfield Park, Ill.-based Baxter misled investors about problems with the Colleague pump, which the FDA eventually ordered Baxter to recall and destroy. Read more
The FDA termed a recall by St. Jude Medical of a small number of its Optisure defibrillator leads as Class I, denoting the risk of serious injury or death.
Little Canada, Minn.-based St. Jude notified physicians in a Nov. 3, 2015, letter that a technique used to strip adhesive from the Optisure’s superior vena cava shock coil could inadvertently damage the lead’s insulation, the FDA said. Of the 447 implantable cardioverter defibrillator leads affected, 281 were distributed in the U.S. and rest in Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, Holland, Saudi Arabia, and Sweden, according to the federal safety watchdog. Read more