Medical Devices Today

Medtech Venture Capital: The View From Europe

Article preview from Start-Up - May 1, 2011

Medical device companies have always faced technological, regulatory, reimbursement and market risk, and a new risk has been recently added to this existing set of challenges: financing risk. Longer product development cycles mean sustained funding requirements, at a time when venture funds are less numerous and smaller, and syndicates have become difficult to assemble.

Leaving Medtronic: Bill Hawkins' Legacy

Article preview from IN VIVO - May 1, 2011

Prominently displayed in Bill Hawkins' office is a sword – a Viking sword, Hawkins points out -- a gift from Art Collins, the man who preceded Hawkins as CEO of Medtronic Inc. The gift was designed symbolically to help Hawkins "cut through the bureaucratic red tape" and "deal with the intense competitive environment."

HRS 2011: What's Hot, What's Not, in AF Ablation

Article preview from Medtech Insight - June 1, 2011

Presenters at a day-long AF Symposium held just prior to this year's Heart Rhythm Society meeting lamented the disappointing long-term results with AF ablation and spoke about upcoming technological advances in catheters and adjunctive tools that may improve the procedure's efficacy and durability.

Could Regulatory Science Raise The Bar For Industry?

Article preview from "The Gray Sheet"- August 29, 2011

FDA is pouring more time and money into the field of regulatory science, and device makers would be wise to wonder: how will this affect us?

Sirius Implantable Systems Ltd.

Article preview from Start-Up - May 1, 2011

Intertwining technologies of a miniature left ventricular pacemaker with a leadless electrode from Israeli-based Sirius Implantable Systems Ltd. may someday improve the quality of pacing therapy and reduce the incidence of complications associated with conventional electrical wiring for standard pacemakers. Sirius' unique self-powered pacemaker and the leadless electrode will be implanted on the left side of the heart by minimally invasive surgery and can be matched with any standard pacing device in the market.

Are Device VCs Becoming Spineless?

Article preview from IN VIVO - May 1, 2011

Increasing concerns over the cost and efficacy of spinal procedures have chilled VC interest in spine companies, once the hot growth area in orthopedics. So, if spine is not the answer, where will VCs find investment opportunities in orthopedics, which remains one of the largest device sectors?

At PCR, Interventional Cardiology Looks East Not West

Article preview from Medtech Insight - 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.

FDA Guidance Emphasizes Randomized, Blinded Trials For PMAs

Article preview from "The Gray Sheet"- August 22, 2011

Clinical studies in support of pre-market approval applications should ideally be randomized and blinded, FDA maintains in recent guidance.

 

Journal Editors Criticize FDA’s Quick Dismissal Of IOM Advice

Article preview from "The Gray Sheet"- August 15, 2011

Editors of two premier peer-reviewed medical journals are calling out FDA for its quick, dismissive response to the Institute of Medicine’s recommendation to replace the 510(k) program.

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.