MedTech News
FDA accepts Onward BCI into advisory program
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.
FDA clears pulsed field ablation electrode tech from Pulse Biosciences
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system.
FDA panel backs Lumicell’s agent for breast cancer imaging tool
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
FDA clears Getinge’s cardiovascular surgery offering, company launches new table, light in U.S.
Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools.
Lumicell earns positive FDA panel decision on surgical imaging tool, approval decision expected soon
Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering.
Beckman Coulter receives FDA clearance for DxFlex Clinical Flow Cytometer
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 wins FDA nod for hydrophilic synthetic bone graft
SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.
Shape-shifting ultrasound stickers detect post-surgical complications
First-of-its-kind device ‘tags’ an organ to monitor abnormal, life-threatening fluid leaks