Medtronic (NYSE:MDT) said this month that it won approval for a change to its problematic SynchroMed II implantable drug infusion pump designed to address motor shaft wear issues. The Fridley, Minn.-based medical device titan said the change is aimed at improving the long-term rate of non-recoverable motor stall in the SynchroMed II devices, estimating that pump […]
Repro-Med clears FDA warning letter, shuffles C-suite
Repro-Med Systems (OTC:REPR) said last week that the FDA cleared a 2016 warning letter for its Freedom 60 syringe infusion pump and Freedom Edge infusion pump and made some changes in the executive suite. Repro-Med, which does business as RMS Medical Products, said the closure of the warning letter stemmed from its successful bid for 510(k) clearance […]
Price caps to keep Abbott’s Xience Sierra off the Indian market
Abbott (NYSE:ABT) reportedly won’t introduce its next-generation drug-eluting stent, the Xience Sierra, to the Indian market due to price caps there. The everolimus-eluting coronary stent, which won CE Mark approval in the European Union this week, is designed to allow cardiologists to treat the complex lesions that make up roughly 70% of cases. It offers […]
Abbott wins CE Mark for next-gen Xience Sierra drug-eluting stent
Abbott (NYSE:ABT) said today that it won CE Mark approval in the European Union for its next-generation drug-eluting stent, the Xience Sierra. The everolimus-eluting coronary stent is designed to allow cardiologists to treat the complex lesions that make up roughly 70% of cases, the Chicago-area healthcare giant said. It offers a thinner profile, increased flexibility, […]
Drug delivery biz fuels healthcare segment growth for 3M
Sales and operating profits for the healthcare business at 3M Cos. (NYSE:MMM) rose during the third quarter, helping the industrial conglomerate top the consensus sales and earnings forecasts and sending share prices up today on Wall Street. 3M Health Care’s operating profits rose 9.3% to $471 million for the three months ended Sept. 30, compared […]
FDA warns Magellan Diagnostics on lead tests
The FDA today warned Meridian Bioscience (NSDQ:VIVO) subsidiary Magellan Diagnostics based on the Class I recall of its lead poisoning tests, accusing the company of failing to protect patients after it learned of problems with the tests. The May recall, which was expanded in July, involves Magellan’s LeadCare, LeadCare II, Ultra and Plus products. The tests may underestimate blood lead levels […]
Layoffs ahead for nearly 300 in Pennsylvania as J&J winds down Animas
Johnson & Johnson (NYSE:JNJ) plans to lay off nearly 300 workers in Pennsylvania as it winds down its Animas insulin pump business. The layoffs for 297 are slated for Animas operations in West Chester and Wayne, Pa., effective Dec. 15, according to a notice filed with the Commonwealth’s Dept. of Labor & Industry. J&J announced the […]
Insulet, Dexcom partner to lure ex-Animas users
Insulet (NSDQ:PODD) and Dexcom (NSDQ:DXCM) yesterday floated a joint promotion aimed at luring users of the Animas insulin pump after Johnson & Johnson (NYSE:JNJ) bails out of the insulin pump biz. The companies are hoping to chip off a piece of the diabetes market from Medtronic (NYSE:MDT), to which J&J has offered to help some 90,000 Animas patients transfer (J&J is also evaluating another […]
OptiNose IPO pulls in $120m
OptiNose (NSDQ:OPTN) raised $120 million with its initial public offering last week, adding $20 million to the target is set earlier this month. Yardley, Penn.-based OptiNose floated 7.5 million shares at $16 apiece in the offering, above the range it set Oct. 3 for 6.3 million shares at $15 to $17 apiece. The stock, trading on the […]
Johnson & Johnson to shutter Animas insulin pump biz
Johnson & Johnson (NYSE:JNJ) said today that it plans to shut down its 410-worker Animas insulin pump subsidiary, offering to help some 90,000 Animas patients transfer to products made by rival Medtronic (NYSE:MDT). The Chesterbrook, Pa.-based company said it will stop making its Animas Vibe and OneTouch Ping pumps, but will continue to provide customer […]
