FDA issued a proposed rule that introduces five newly defined categories that describe situations for devices when a class III designation, requiring a PMA and other heightened standards, will always be necessary.
Continue reading "What Makes A Device Class III? FDA Proposes New Language To Clarify" »
At the recent CIRCE meeting, researchers presented positive clinical data comparing Benvenue Medical Inc.’s Kiva vertebral compression fracture system versus Medtronic’s market-leading Kyphon kyphoplasty system, providing a boost for Benvenue, which is awaiting FDA 510(k) clearance of its device.
Continue reading "Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures" »
Large or small, Series A rounds in the device sector don’t have a statistical correlation with exit value, but there is some evidence that initial runway has some influence.
Continue reading "Device Firms See No Correlation Between Series A And Exit" »
SYMPLICITY Results Make Life Difficult For Renal Denervation Programs
The big slice of the device industry, from large-cap firms to venture capitalists, with some stake in the renal denervation opportunity are trying to understand the new reality now that Medtronic’s pivotal Symplicity renal denervation device trial missed its endpoint.
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China has been talking about implementing a UDI system to track distribution of medical devices for years. Former CFDA and U.S. FDA experts now suggest that China plans to implement such as system by year end.
Continue reading "China Hopes To Implement Unique Device Identifier System By Year End" »
Stryker’s adoption of MAKO’s RIO (Robotic-arm Interactive Orthopedic) system could give the global medical supplier a competitive edge over other orthopedic implant makers if the company can win converts to robotic surgery by leveraging its own experience in selling capital equipment.
Continue reading "Will Stryker’s MAKO Purchase Bring Disruption To The Ortho Industry?" »
After a lull, or at least a single-minded focus on femtosecond lasers for a time, refractive surgery has gotten exciting again: the drive to spectacle-free outcomes for cataract patients (who have aged-out of their eligibility for other refractive procedures) is calling for solutions that offer precision and accuracy at every stage of treatment. Start-ups coming up with the solutions will be serving some gigantic markets.
To stave off the sluggish growth in established markets, multinational medtechs not only are finding new business in countries with booming health care industries but they’re also forging new ways to serve customers. Device companies now are pushing into services, such as disease management, and angling to compete more aggressively on pricing.
Continue reading "Medtech 2013: Device Companies Go Where The Growth Is" »
In an interview with “The Gray Sheet,” CDRH’s Acting Clinical Trials Director Owen Faris discusses the device center’s new pre-market clinical trials program aimed at speeding up approval times for investigational device exemptions and increasing the number of IDE trials in the U.S.
Continue reading "CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals" »
BioVentrix Inc. is developing a unique, minimally invasive approach to reshaping the heart’s scarred and enlarged left ventricle aimed at patients who develop ischemic heart failure following a heart attack. The company has made considerable headway with its technology, which offers an interesting balance between a catheter-based and surgical-based procedure; however, CEO Kenneth Miller, well aware of the pitfalls that have plagued earlier companies in this field, is taking a cautious approach to the US market.
