The clearance allows the platform to host artificial intelligence algorithms that aid in disease risk prevention.
It also expands the population that can be managed...
The FDA also approve treatments requiring a companion IVD test even if a corresponding diagnostic has not yet received marketing authorisation.
The US Food and...
Vigilant Biosciences, a developer of solutions that aid in the early detection of oral cancer, has received Breakthrough Device Designation from the Food and...
The FDA-cleared software offers multimodality image processing and reporting.
Hungary-based hybrid imaging supplier Mediso has received clearance from the US Food and Drug Administration (FDA)...
Class II clearance expands the patient population that can be managed
Companies working with Huma's platform can now launch algorithm innovations more quickly in a...
The SI joint implant uses Nanotex surface technology to improve bone growth.
SurGenTec has secured approval from the US Food and Drug Administration (FDA) for its TiLink-L...
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, announced that the Arrow® EZ-IO® Needle is the first and...
Radius VSM helps clinicians monitor various physiological measurements.
Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its patient-worn, continuous multi-parameter vital...
