510(k) Clearance Archives

Abbott Gains FDA 510(k) Clearance for First Rapid Handheld Blood Test for Concussions

510(k) Clearance, Approvals, Concussions, FDA

Abbot received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions.

FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

510(k) Clearance, Approvals, FDA, Medical Devices

The U.S. Food and Drug Administration permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.

Anika Announces FDA 510(k) Clearance for Injectable HA-Based Bone Repair Treatment

510(k) Clearance, Approvals, Bone Grafts, FDA, FDA/Regulatory, Musculoskeletal, Orthopedics, Technology

Anika Therapeutics Inc. announced that its HA-based bone void filler received 510(k) clearance from the U.S. FDA and is indicated for filling bone voids or defects of the skeletal system, which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.