Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications. “I’m nervous about the prospect of there never being a COVID vaccine that meets the […]
Regulatory
FDA announces regulatory updates under 21st Century Cures Act
The 21st Century Cures Act aimed – among other things – to amend the Federal Food, Drug, and Cosmetic Act to more closely align device and drug regulations. FDA is updating regulations to reflect some of the 6-month-old law’s changes. Details can be found in today’s Federal Register. Specifically, the 21st Century Cures Act amended Humanitarian Device […]
Critic questions FDA’s handling of Essure product complaints
FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts. “Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an […]
Real-world evidence for medtech: what you need to know
Real-world evidence for medical devices has generated a lot of attention in medical device circles since FDA issued guidance about it last summer. The 21st Century Cures Act, passed by Congress in late 2016, actually promotes real-world evidence. The practice offers a way for a medtech company to prove safety and efficacy without necessarily having […]
FDA clears Synaptive Medical’s ‘GPS for the brain’ technology
Synaptive Medical gained FDA clearance to start marketing its neurosurgery-specific surgical navigation tech for use in U.S. operating rooms.
The Toronto company said its BrightMatter Guide system cleared this regulatory sign-off after “months of review.”
Tattoo removal: FDA clears Cynosure’s 532 nm laser system
The FDA has cleared Cynosure’s (NSDQ:CYNO) 532 nm Laser Delivery System for its PicoSure tattoo-removal technology platform.
Cynosure said the regulatory win will enable the PicoSure system to remove all colors of ink in fewer sessions.
FDA seeks to speed updates to “superbug” device labels
(Reuters) – The U.S. Food and Drug Administration is working to speed label changes for medical devices linked to a "superbug" outbreak in California, possibly to include new warnings and more stringent cleaning and disinfecting instructions, a senior official said.
FDA clears Bioness’ StimRouter device for chronic pain
The FDA has granted market clearance for Bioness' Stimrouter for the treatment of chronic peripheral pain.
The company describes StimRouter as a minimally invasive, implanted neuromodulation device that sends electrical signals to the pain's point of origin. The device is controlled by a wireless, hand-held unit.
UK appoints top med device regulator
The UK’s equivalent of the FDA has named a prominent British anesthesiologist as its top medical devices regulator.
Report: FDA grounds plan to test unmanned inspection drones
An FDA proposal to test unmanned drones in facility inspections was grounded before it could take flight, according to a report in Regulatory Focus.
An internal FDA memo obtained by the publication revealed that the agency was planning to "perform a test of drone technology" sometime this week.
Japanese elder care market: 4 key medical device segments
By Ames Gross, President, Pacific Bridge Medical
