Medical Devices Today

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

Full article reprinted from "The Gray Sheet"- February 16, 2009

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...

CDRH Task Force Stirs Debate About FDA's Comparative-Effectiveness Role

Full article reprinted from "The Gray Sheet"- February 16, 2009

FDA stakeholders debated Feb. 9 whether it is appropriate for the agency to compare the effectiveness of new devices to the status quo as part of its pre-market reviews. Read more...

AAO Highlights: Back (of the Eye) to the Future

Article preview reprinted from Medtech Insight - January 2010

The 2009 meeting of the American Academy of Ophthalmology showcased the latest developments in cataract/refractive surgery, glaucoma, retina, and other ophthalmic subspecialties. The cataract/refractive surgery market has been under significant economic pressure recently due to a recessionary drop in elective ophthalmic procedures. However, evolving treatments for "back of the eye" conditions, such as age-related macular degeneration (AMD) and diabetic retinopathy, are making significant inroads toward improved patient outcomes for these common and devastating diseases and continue to energize the retina products market. Read more...

Has Orthovita's Fight Finally Ended?

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

Orthovita had spent the past eight years building up a small commercial pipeline while it ran its flagship bone augmentation material Cortoss through years of a demanding clinical trial. But two months after the FDA approved the product, the company had to clear another unforeseen hurdle: two controversial clinical trials. Read more...

Is there a Market for Wireless Cardiac Monitoring Implants?

Full article reprinted from Start Up - December/January 2010

Transoma, which was developing an implantable ECG monitor for continuous, wireless arrhythmia monitoring closed its doors in December. Before that, Medtronic failed to gain FDA approval for an implantable hemodynamic monitor for heart failure. That's two strikes; what will it take for companies with implants for wireless monitoring to stay in the game? Jay Yadav, MD, of CardioMEMS gives his opinion. Read more...

Comparative Effectiveness Gets Nod In Federal Budget Request

Full article reprinted from "The Gray Sheet"- February 8, 2009

Funding comparative effectiveness research remains a priority of the administration, as evidenced by the $286 million earmarked in the president's fiscal year 2011 budget to "advancing patient-centered health research" at the Agency for Healthcare Research and Quality. Read more...

Obama Budget Request Would Fund National Device Registry At FDA

Full article reprinted from "The Gray Sheet"- February 8, 2009

The Obama administration's fiscal year 2011 budget request includes $4 million for a new medical device registry that would link unique device identifiers to electronic health data. The registry would be designed and built by FDA. Read more...

Mobile Health Device Field Seeks Regulatory Guidance From FDA And FCC

Full article reprinted from "The Gray Sheet"- February 8, 2009

Even as the use of mobile wireless devices for medical applications burgeons, some would-be entrepreneurs and venture capitalists are holding back from entering the field until they get a better handle on the regulatory hurdles involved. Read more....

Medtronic buys Invatec for $350mm, plus earn-outs

Deal summary reprinted from Strategic Transactions - January, 2010

Medtronic has agreed to acquire closely held European interventional cardio device developer Invatec and its affiliates Fogazzi (provides Invatec with polymer technology) and Krauth Cardiovascular (Invatec's German distributor) for $350mm. It will also provide earn-outs of up to $150mm if certain milestones are reached.

Top Device Stories of the Decade

Article preview reprinted from IN VIVO -  December/January 2010  

EBI's Medical Device Team

When we first discussed appending a "Top Stories of the Decade" to our annual Top Ten feature, the reaction was mixed. On the one hand, we thought most readers could probably recite them off the top of their heads as easily as we could. But when we began to compile the list, a few things jumped out, well worth reiterating: the prolonged back and forth of the debate over drug-eluting stents (DES), in some ways a first look at how a comparative effectiveness research mindset can move clinicians, but not necessarily in a uniform direction over time; the strength and distinctiveness of orthopedics dealmaking; the emergence of areas such as opththalmology and aesthetics; and the steady turn towards financing devices as an alternative to pharma, with its own distinctive characteristics and arguments in their favor. Read more...