Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology.
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system.
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools.
Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering.
Beckman Coulter Life Sciences, a laboratory automation and innovation company, has received 510(k) clearance from the Food and Drug Administration (FDA) to distribute its DxFLEX Clinical Flow Cytometer in the United States.
SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.
First-of-its-kind device ‘tags’ an organ to monitor abnormal, life-threatening fluid leaks
A nanosurgical tool – about 500 times thinner than a human hair – could give insights into cancer treatment resistance that no other technology has been able to do, according to a new study.
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.