
Device maker ConvaTec landed in the FDA’s cross hairs after the company recalled a device that the agency says never underwent regulatory review.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Device maker ConvaTec landed in the FDA’s cross hairs after the company recalled a device that the agency says never underwent regulatory review.
ConvaTec is cutting nearly 120 employees from its Skillman, N.J., headquarters and moving its operations to a smaller facility in the state, according to a local report.
ConvaTec named John Cannon acting CFO following the departure of Edward Borkowski, who left the company for undisclosed reasons. Cannon moved up the ranks from his former position as VP of finance for the company’s global operations.
Before ConvaTec, Cannon worked in banking at PMC Treasury, Singer Sewing and Bankers Trust/Deutsche Bank.
U.K. regulators issued a safety alert for some endotracheal tubes produced by Unomedical, a subsidiary of ConvaTec. The U.K. Medicines & Healthcare Products Regulatory agency is asking healthcare providers to identify and return affected devices to ConvaTec.
The damaged devices are sold under 3 product names: the Unomedical UnoFlex, the Euromedical TrachealFlex and the PharmaPlast The endotracheal tubes are single-use products used to provide an unobstructed airway to and from the lungs.
ConvaTec is claiming victory in a U.K. patent battle with Smith & Nephew (FTSE:SN, NYSE:SNN) over silver wound dressings.
Sony Corp. (TYO:6758) plans to become the largest shareholder in Olympus (TYO:7733) with a $642 million investment that will give it an 11% stake in Olympus.
Four medical device companies reeled in more than $70 million in recent weeks, to develop technologies including a laser scalpel for minimally invasive surgeries, a peripheral vessel stapler, a thermal ablation system and a biliary stent.
Cambridge, Mass.-based OmniGuide led the charge with a $35 million round from Orbimed Advisors. OmniGuide chairman Yoel Fink told MassDevice.com in 2010 that the device uses the mirror technology he pioneered at the Mass. Institute of Technology in the 1990s.
The University of Michigan is suing St. Jude Medical (NYSE:STJ), accusing the medical device maker of failing to pay $4.3 million in royalties on sales of St. Jude’s Epic and Trifecta cardiovascular valves.
Following his abrupt resignation from the corner office at Stryker Corp. (NYSE:SYK), Stephen MacMillan also stepped down from the Texas Instruments board of directors.
MacMillan had been on the board since 2008. No reason was given for his departure in regulatory filings.
NuVasive (NSDQ:NUVA) closed its $80 million pickup of Impulse Monitoring Inc. last week, according to a filing with the federal Securities & Exchange Commission.
The deal, which closed Oct. 7, saw IMI’s shareholders receive nearly $40.5 million in cash and more than 2.3 million shares of NuVasive common stock with an aggregate value of about $40.5 million (per NUVA’s Oct. 6 closing share price of $17.32).