FDA panel backs Lumicell’s agent for breast cancer imaging tool
March 11, 2024
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
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.
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.
Medtronic (NYSE: MDT)+
announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system.
Boston Scientific (NYSE: BSX)+
announced today that it received FDA approval for its Agent drug-coated balloon (DCB).
Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging.
FDA Clears Soldier Microcatheter for Localized Drug Delivery in Vascular Interventions