InVivo Therapeutics wins humanitarian use device status from the FDA for its biopolymer scaffold, designed to treat spinal cord injuries, clearing the way for approval of a pivotal trial.
InVivo Therapeutics (OTC:NVIV) said the FDA deemed its biopolymer scaffold, designed to treat spinal cord injuries, to be a humanitarian use device.
The designation means the InVivo scaffold can seek expedited approval from the FDA for a pivotal trial of the device. HUD-based exemptions cover devices aimed at treating rare diseases and health problems, so-called "orphan" conditions.
Growing obesity in the U.S. means that medical device manufacturers, along with many other industries, must revise their products to accommodate a "larger" market.
MASSDEVICE ON CALL — Makers of durable medical equipment have had to shift their manufacturing parameters in recent years in order to accommodate the ever-growing rates of obesity in the U.S.
It's sometimes a "heartbreaking" situation for patients, but it's also a potentially lucrative opportunity for device makers and clinicians. Clinics generally pay a premium for bigger devices, but the technology has become a medical necessity.
Johnson & Johnson's OneTouch Verio IQ blood glucose meters were found to shut off at extremely high glucose levels, prompting a recall of all lots of the device.
The FDA announces a public meeting to discuss international cooperation in monitoring and assessing cardiovascular medical devices, with an initial pilot phase to focus on transcatheter heart valves.
The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.
The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."
Hitachi Medical wins 510(k) clearance from the FDA for its scalable Scenaria Advanced 128 CT scanner
Hitachi (NYSE:HIT) said it won 510(k) clearance from the FDA for its Scenaria Advanced 128 CT scanner, the latest in its line of scalable CT scanners.
Hitachi Medical Systems America said the latest iteration of the Scenaria Advanced includes new low-dose technology designed to reduce patients' exposure to X-ray radiation.
Dr. John Halamka, Chief Information Officer for Beth Israel Deaconess Medical Center, records his experiences with infrastructure, applications, policies, management and governance.
The March HIT Standards Committee focused on streamlining test scripts for certification, an overview of FDA Universal Device Identifier rule making, clinical summary formats for Long Term Care, and the latest updates from ONC.
We began the meeting by reflecting on the recent HIMSS conference, noting that the culture and momentum for EHR and HIE adoption in the US have changed to the point that there is no longer of question achieving our meaningful use attestation goals.
The FDA grants 510(k) clearance to Medtronic's Affinity Fusion blood oxygenation systems, designed to replicate the lungs' function during open heart surgeries.
Medtronic (NYSE:MDT) said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs.
The Minneapolis-area medical device company, which is the world's largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient's blood to remove particles and air during oxygenation.