Health Affairs10d
FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not ...
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
Hosted on MSN2d
Onward wins FDA approval for ARC-EX system in spinal cord injury patients
Shares in the company were up 7% at market open following the first approval for a non-invasive spinal cord stimulator for ...
Rubber World13d
FDA issues Class I recall for medical devices due to silicone separation
The FDA has issued a recall for certain VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, adding these devices to ...
ResMed product recall classified as most serious by FDA (update)
Update 03.16 PM EST: Adds comments from ResMed The U.S. Food and Drug Administration ... for its respiratory care devices, ...
Becker's Spine Review3d
Onward's spinal cord stimulator earns FDA nod
Onward's Arc-Ex spinal cord stimulator earned the FDA's de novo classification and U.S. market authorization, according to a Dec. 19 news release.
Newsweek22d
Pie Recall Update As FDA Sets Most Serious Risk Level
In an update on Saturday, the FDA said that the risk classification for the recalls is Class I—a situation in which there is a reasonable probability that the use of or exposure to a violative ...