News

News-Medical.Net5h
FDA Breakthrough Device designation granted for AI-based mammogram analysis tool
A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman's personalized ...
Healio1d
FDA grants 510(k) clearance to devices that streamline Hyqvia administration
The FDA granted 510(k) clearance to two devices, HyHub and HyHub Duo, that act as docking stations for dual vial units to ...
Medical Device Network on MSN2d
Stereotaxis wins FDA clearance for diagnostic mapping catheter
MAGiC Sweep is claimed to be the first robotically navigated electrophysiology mapping catheter approved by the FDA.
Becker's Hospital Review5d
10 spine innovations earning FDA nods
From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.
FDA Sued Over Allegedly Defective Spinal Cord Stimulators
A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...
American Hospital Association5d
FDA issues most serious recall for Edwards Lifesciences cannulas
The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula ...