The Institute of Medicine committee charged with reviewing FDA's 510(k) device pre-market review program is urging the agency to ditch the 35-year-old program and start fresh.
After 16 months of work, the IOM committee, chaired by David Challoner, VP for health affairs emeritus at University of Florida, released its long-awaited, and sure-to-be controversial, recommendations July 29 in a 245-report titled "Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years."
Four years following FDA approval, Lucentis remains the standard of care for the treatment of neovascular (wet) age-related macular degeneration (AMD) and has been widely adopted for off-label treatment of other retinal diseases. Companies are pursuing new drugs that may have more favorable dosing profiles, device-based technologies that may reduce the dosing frequency of Lucentis, and implantable drug delivery vehicles designed to deliver drugs to the back of the eye that may be applicable to a broad range of retinal therapies.
Despite mounting evidence that controlling blood sugar levels in critical care patients reduces complications and shortens the length of ICU stay, clinicians have found total glucose control hard to achieve because of the frequent testing required to achieve tight management. GlySure Ltd. is developing a continuous intravascular glucose monitoring system based on optical fluorescence.
OrthoSensor is trying to bring a data-driven revolution to orthopedics. It is building a three-legged platform, with intelligent instruments, intelligent implants, and analytics, all driven by sensor and other micro-electronics technology that feed back to surgeons vital data both intra- and post-operatively.
The editors of three premier peer-reviewed medical journals say two widely circulated reports criticizing FDA's medical device review process are deeply flawed, biased and should play no part in discussions over FDA regulatory reforms.
Medtech start-ups are jumping aboard the lucrative fat reduction trend, and all signs point to a boom in this market in the coming years. Despite the sluggish economy, consumers are still willing to pay out of pocket for procedures that enhance their looks.
Drug-eluting balloons might someday pick up where drug-eluting stents leave off, promising to solve problems not addressed - and even created - by DES. However, despite what interventional cardiology companies have learned about device and drug combinations, the drug-coated balloon markets aren't as simple as they might at first seem.
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.
FDA's draft guidance on the development of companion diagnostics for drug therapies, released July 12, delivers on a promise to publicly outline how it will address review of those products, but at only 12 pages, it has left some in industry longing for more insight.
Innovation in intubation devices, particularly video-enabled technology, is breathing new life into the market for airway management products. At the 2010 meeting of the American Society of Anesthesiologists, held in San Diego in October, manufacturers showcased a variety of new intubation devices designed to improve visualization, avoid complications, and provide fast and simple solutions for patients with difficult airways.
