Healthcare joint venture Haven, started by Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan, has lost its COO Jack Stoddard at just nine months post-hiring, according to a CNBC report. The former digital health general manager for Comcast told the news channel that he is departing the healthcare play due to personal reasons, including the distance between […]
HRS 2019 Roundup: Medtronic touts extravascular ICD pilot
The pilot study of an extravascular implantable cardiac defibrillator developed by Medtronic (NYSE:MDT), which is designed to deliver both defibrillation and anti-tachycardia pacing using leads placed outside the heart and venous system, showed strong safety and efficacy results. The safety outcome for the 26-patient study, presented last week at the annual meeting of the Heart […]
Boston Scientific gets into spine with $465 Vertiflex buy
Boston Scientific (NYSE:BSX) moved into the orthopedics space with a $465 million buyout of spinal implant maker Vertiflex. The deal, announced this morning and expected to close late in the second quarter of 2019, includes commercial milestones spaced out over three years. Carlsbad, Calif.-based Vertiflex makes the Superion decompression device for treating lumbar spinal stenosis, which […]
Boston Scientific wins FDA approval for Vici peripheral venous stent
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for the Vici peripheral venous stent it acquired when it bought Veniti last year. Marlborough, Mass.-based Boston Scientific said the FDA approved Vici for treating iliofemoral venous obstructive disease. The company inked a deal worth up to $160 million last August to acquire the […]
Investor lodges class action suit against Boston Scientific over U.S. mesh withdrawal
A plaintiff purporting to represent Boston Scientific shareholders sued the company yesterday, alleging that it misled investors about the prospects for its pelvic mesh products ahead of an FDA order to halt all U.S. sales of the devices. Last week the FDA ordered an immediate halt to sales and distribution of Boston’s Uphold Lite and Xenform products; […]
Boston Scientific’s Q1 numbers miss the mark
Boston Scientific (NYSE:BSX) missed the mark with its first-quarter results today and cut it’s top-line outlook for the rest of the year, sending share prices down before the market’s open. The Marlborough, Mass.-based medical device giant posted profits of $424 million, or 30¢ per share, on sales of $2.49 billion for the three months ended March […]
Boston Scientific wins FDA approval for Lotus Edge TAVR
Boston Scientific (NYSE:BSX) said yesterday that it won pre-market approval from the FDA for its Lotus Edge transcatheter aortic valve replacement for high-risk patients. Marlborough, Mass.-based Boston Scientific touted the device as the only TAVR on the U.S. market designed to be repositioned or recaptured after deployment. The path to PMA wasn’t an entirely smooth one; […]
Report: Boston Scientific worker faces ‘Ultimate Hell Week’ on Irish reality show
A Boston Scientific (NYSE:BSX) employee is facing “Ultimate Hell Week” for a new Irish reality television series that premiered this week, according to a County Tipperary report. In the series, dubbed “Special Forces: Ultimate Hell Week,” 24 civilians face an eight-day army style selection course designed by former members of the country’s special forces unit, the […]
FDA’s pelvic mesh ban spooks investors
The FDA’s ban on U.S. sales of pelvic mesh products for pelvic organ prolapse may have spooked investors, but should only have a minimal effect on the books at Boston Scientific (NYSE:BSX) and Coloplast (CPH:COLO-B) – the only companies still selling mesh for prolapse in the U.S. – according to analysts and the company. Yesterday the […]
FDA bans Boston Sci, Coloplast sales of pelvic mesh
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the […]
Channel Medsystems wins PMA for Cerene cryoablation device
Channel Medsystems last week won pre-market approval from the FDA for its Cerene endometrial cryoablation device, starting the clock on a mandatory three-year post-approval study. Cerene, which is designed to treat heavy but benign bleeding in premenopausal women for whom child bearing is complete, won CE Mark approval in the European Union in June 2017. The PMA […]
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