STAT1d
FDA authorizes many AI devices for use in kids. Are they validated in a pediatric population?
A new study resurfaces long-simmering concerns about the lack of transparency in data used to train and validate AI and ...
CardioFocus treats first patients in OptiShot pulsed field ablation system trial
The first-in-human trial is taking place at Na Homolce hospital in Prague, Czech Republic, and will treat up to 50 patients.
Health Affairs5d
FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
Devices that are approved through a process that does not require any clinical evidence for FDA authorization should not ...
MassDevice8d
SetPoint Medical submits neuromod device to FDA
SetPoint Medical announced today that it filed with the FDA for premarket approval (PMA) of its neuroimmune modulation device.
GlobalData on MSN6d
MeMed’s sepsis test receives FDA breakthrough device status
The test builds upon the MeMed BV test, which assists clinicians in distinguishing between bacterial and viral infections.
Tyber Medical Achieves Class III MDR CE Mark Certification from BSI for PEEK Titanium Plasma-Coated Cervical Cages
Tyber Medical LLC, a leading provider of private-label orthopedic and spinal implants, proudly announces that it has received ...
aha.org12d
FDA finalizes recommendations simplifying approval process for medical devices that use AI
The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices ...
Medicine Buffalo9d
UB expert part of FDA committee that looked at AI-enabled medical devices
BUFFALO, N.Y. — The U.S. Food and Drug Administration says there are more than 900 artificial intelligence and machine learning-enabled medical devices ... infrastructure for such devices is still ...