An unprecedented release of data by the agency highlights vast differences across the country between what hospitals charge for different procedures, but the disparities by and large don’t reflect actual hospital costs.
Beaten down by the great recession, the large joint arthroplasty market appears to be on the cusp of a turnaround, with several big players reporting encouraging Q4 and full-year 2012 results. A full recovery in this space is likely to take some time, but technology advances could help jumpstart the process, and there may be some interesting dynamics ahead in the patient-specific implant and robotic ortho device arenas.
The European Commission revised the Restriction of Hazardous Substances in Electrical and Electronic Equipment directive last May, and expanded its scope to include medical devices and in vitro diagnostics sold in the EU within the next two to four years.
For biotech companies and their backers, the structured acquisition -- with contingent payments that stretch well beyond the close of the sale -- is practically the only exit available and, everyone agrees, a permanent part of the landscape. While it's certainly a buyer's market, the sellers have begun to adopt strategies and rules to help boost returns. Are they working?
The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.
With foresight, good timing, or simply years of experience, the founders of Sequent Medical (who also founded MicroVention) are launching a new endovascular product in Europe just as large companies are signalling their interest in the space via acquisitions. For the treatment of cerebral aneurysms, Sequent has developed a novel device that combines the best attributes of embolization coils and flow diverters, its founders believe.
As institutional venture firms gird themselves for difficult times ahead in raising new funds, investment programs at pharmaceutical companies and large medical device companies are at least partially filling the gap by committing corporate dollars into private life sciences companies, even in earlier stages.
Is innovation in the diabetes device market being hampered by a slowdown in FDA approvals? That question was the unofficial, under-riding theme at the American Diabetes Association 71st Scientific Sessions in June.
As venture investing in medical devices continues to split between early- and late-stage deals, investors increasingly face a choice: early-stage deals, where valuations are low, but risk is high and timelines are generally long; and late-stage opportunities, where risk is lower and timelines shorter, but the valuations are much higher. What if you could find an opportunity with the timelines and risk profile of a late-stage deal, at the valuation of an early-stage deal? That's what investors at Abingworth believe they've found in Lombard Medical Technologies PLC, a company with a novel approach to endovascular abdominal aortic aneurysm repair.
With its $2.9 billion acquisition of American Medical Systems, Endo Pharmaceutical Holdings is further diversifying its specialty pharma portfolio into devices and services.