Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report. “Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the […]
Boston Consulting Group
How much time and money does it take for FDA 510(k) clearance versus De Novo classification?
If you’re developing a new medical device and want to know how much time and cash it could take to get FDA 510(k) clearance or De Novo classification, a recent report offers some guidance. Boston Consulting Group and the UCLA Biodesign innovation hub questioned leaders at 102 different companies that have achieved registration or approval […]
Poll: Nearly half of medtech women executives’ companies ready for pandemic’s second wave
Nearly half of medtech executives polled in a recent survey said their companies are prepared for the second wave of the COVID-19 pandemic that is sweeping the globe. Forty-eight percent of the 71 MedExecWomen Fall Forum attendees who responded to the question reported their companies’ readiness hinged on scalable remote commercial capabilities, a bolstered supply chain […]
Johnson & Johnson, Medtronic make BCG’s most innovative list
Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) were named in the Boston Consulting Group’s list of the 50 most innovative companies this year at the 20 and 42 spot, respectively. Apple (NSDQ:AAPL) and Google (NSDQ:GOOG) took the top 2 spots on the list. Other notable entries were Gilead at number 8, Bayer‘s (ETR:BAYN) at 11, Biogen (NSDQ:BIIB) at […]
Boston Scientific: ‘Favorable’ 6-month results from award-winning Lotus aortic valve study
LeMaitre Vascular pays $5M for Neovasc’s XenoSure | Wall Street Beat
LeMaitre Vascular (NSDQ:LMAT) said it will pay $4.6 million for Neovasc‘s (NYSE:NVC) XenoSure vascular patch, used to repair blood vessels.
New paths to profit
As publicly traded firms ready their year-end financial statements this month it’s clear that the med-tech industry’s high-flying days aren’t coming back any time soon.
Wall Street analysts expect companies in the sector to release cautious forecasts for sales and earnings in 2012, reflecting a series of factors conspiring to put pressure on their top and bottom lines. Lower procedure volumes, pricing pressure and the unstable European economy all play a part, according to Barclay’s Capital analyst Adam Feinstein.
