Medical Devices Today

CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias

Article preview from "The Gray Sheet"- December 12, 2011

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.

Neurovascular Market's Time Has Come: Stealthy Sequent Medical Unveils Strategy

Article preview from Start-Up - September 1, 2011

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.

Corporate VCs Step Up Carefully to Fill VC Void

Article preview from IN VIVO - September 1, 2011

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.

Cautious FDA Is Obstacle For Burgeoning Diabetes Device Market

Article preview from Medtech Insight - August 1, 2011

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.

Abingworth's Bet On Lombard: Best Of Both Worlds For VCs

Article preview from IN VIVO - May 1, 2011

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.

Endo Dives Deeper Into Devices With AMS Acquisition

Article preview from IN VIVO - April 1, 2011

With its $2.9 billion acquisition of American Medical Systems, Endo Pharmaceutical Holdings is further diversifying its specialty pharma portfolio into devices and services.

Device Companies Look West, East, Anyplace But US

Article preview from IN VIVO - June 1, 2011

With clear regulatory approval paths in Europe and growing markets in Asia and other developing markets, device executives and investors see international markets as increasingly attractive alternatives for clinical validation, revenue, and regulatory approval.

At PCR, Interventional Cardiology Looks East, Not West

Article preview from IN VIVO - June 1, 2011

For many years, the Paris Course on Revascularization, Europe's largest showcase of devices and technology used in interventional cardiology, more often looked like a mini-TCT, the US-based meeting serving interventional medicine as well. But in the last couple of years, it's been hard to miss a somewhat diminished role for US physicians. While fewer US physicians have made the trip to Paris, interventionalists from China and India have been coming to PCR in greater numbers.

J&J Renews Commitment To Devices With Synthes Deal

Article preview from IN VIVO - May 1, 2011

Rumors that Johnson & Johnson was looking to exit cardiovascular devices and perhaps go so far as to divest their entire device business apparently can be put to rest in light of the company's recently announced plans to acquire orthopedics leader Synthes Inc.

Device IPO Class of 2007 Making News, Some Returns

Article preview from Start-Up - March 01, 2011

The merger of Accuray and TomoTherapy would combine two of the 11 medical device companies that went public in 2007, a class of companies that has produced mixed results.