Medical Devices Today

Clinical Edge

Article preview reprinted from Medtech Insight - January 2010

Brief summaries of recent advances in device research and clinical trials, including a neural interface for prosthetic limbs, new tools to detect cancer, and results of a multicenter study of the costs of treating MRSA. Read more...

Finsbury's Last Stand

Article preview reprinted from IN VIVO -  January/February, 2010

One of the most innovative and creative orthopedic implant designers, the UK's Finsbury's Orthopedics never quite built the sales and distribution capability to enable it to capture the full value of its designs. The company's recent sale to DePuy underscores how much the orthopedics industry has changed since its earliest days. Read more...

For Device VCs, the Eyes, Heart and Stomach Have It

Full article reprinted from Start Up - January/February 2010

Anyone with access to the right data can tell you which technologies and medical specialties are commanding the highest valuations from device VCs. But what would it be worth to know which companies will be commanding the top prices in the next year? A survey of more than a dozen VCs--who participated with a promise of anonymity--with money to invest draws a very clear picture about what investment opportunities they might find worth fighting over and the areas they'll ignore. Read more...

Bayesian Gets A Boost With Guidance, But Technique Still Not For Everyone

Article preview reprinted from "The Gray Sheet"- February 22, 2010

The complex calculations of Bayesian statistics are not likely to become standard for FDA device submissions anytime soon, but they could help streamline clinical trials in many more instances, CDRH's top statistics official says. Read more...

Boston Scientific, Medtronic Heart Devices Go To Panel In March

Full article reprinted from "The Gray Sheet"- February 22, 2010 FDA's Circulatory System Devices advisory panel will weigh in on two closely watched approval decisions at a March 18-19 meeting. Read more...

FDA Hints At Possible 510(k) Tweaks At Public Meeting

Full article reprinted from "The Gray Sheet"- February 22, 2010

FDA is considering changing how predicate devices are selected for 510(k) submissions and beefing up its post-market authorities for 510(k)-cleared products, agency reps suggested at a Feb. 18 public meeting. Read more...

Injectable Solutions for Joint and Back Pain

Article preview reprinted from Medtech Insight - January 2010

Injectable products that can alleviate pain and even reverse the disease process are on the horizon for treating degenerative orthopedic and spinal conditions, such as damaged articular joint cartilage and deteriorated spinal discs. With no available long-term treatment options for these conditions short of invasive surgical procedures like joint replacement or spinal fusion, injectable technologies that offer the possibility of being used upstream in the continuum of care are potential billion-dollar market opportunities. In fact, in a post health care reform environment, injectable therapies may prove to be the most cost-effective way for treating many degenerative conditions. Read more...

The A-List: 2009's Trend-Shaping Series A Financings

Full article reprinted from Start Up - December/January 2010

New company creation slipped significantly in 2009 as venture capitalists conserved capital and supported existing portfolio companies. In biopharmaceuticals, corporate venture got in at the ground floor while device start-ups continued to see stronger support from smaller, regional investors than traditional VCs. Read more...

The Art of the Deal: Device M&A; in Difficult Times

Article preview reprinted from IN VIVO -  December/January, 2010

Advanced Medical Optics, Ablation Frontiers, Acclarent, CoreValve, Evalve, Visiogen.-no tip of the iceberg last year; they were just about the whole berg in medical device M&A. Starting with AMO last January and ending with Acclarent in December it would be easy to look at the series of impressive device acquisitions that took place last year and be lulled into the belief that 2009 was a banner year for medical device M&A. In fact, just the opposite was true: total deal values and numbers were at their lowest peak in more than half a decade. What does it take to get a company sold these days? To look more closely at the topic, we asked some folks who've recently been on either side of a deal to talk, not so much about the current state of deal-making, but about how successful deals come about in today's environment. Read more...

FDA To Set Standards For CT, Fluoroscopic Devices In Radiation Safety Effort

Full article reprinted from "The Gray Sheet"- February 16, 2010

FDA will develop new safety requirements for computed tomography and fluoroscopic imaging devices as part of an initiative to reduce unnecessary radiation exposure to patients. Read more...