News

FDA Issues New Guidance For AI-Enabled Medical Devices: Why The Threats Are Real And Alarming
AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.
Teleflex receives FDA 510(k) Clearance for Expanded Indications of the QuikClot Control+™ Hemostatic Device
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced U.S. Food and Drug ...
MassDevice16h
Teleflex wins FDA nod for expanded hemostatic device indications
Teleflex (NYSE: TFX) announced that it received FDA 510(k) clearance for expanded indications of its QuikClot Control+ hemostatic device.
MedTech Dive1d
ICU Medical receives FDA warning letter over infusion pumps
Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.
MassDevice4d
FDA says recall of Abbott HeartMate power unit is serious
This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious ...
Becker's Spine Review7d
Medtronic, FDA sued over spinal cord stimulator
A Kentucky woman is suing Medtronic and the FDA alleging that the devicemaker’s spinal cord stimulator made her pain worse and that the agency didn’t diligently review updates to the implant. Angela ...
USA Today13d
FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units ...
MedCity News5d
Orchestra BioMed’s Hypertension Device Wins FDA Breakthrough Designation
Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular interval modulation therapy, meaning it ...
Morningstar12d
FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
April 18, 2025 /PRNewswire/ -- On April 7, 2025, the U.S. Food and Drug Administration ("FDA ... Q'Apel has submitted three Medical Device Reportable events for the Hippo product to date ...