Regulatory Approvals

US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC, announced it has received FDA Approval for its...

NDR Medical Technology has announced that the ANT-X has been granted FDA 510(k) clearance by the U.S. Food and Drug Administration (FDA). This clearance makes...

ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA, the first fully-automated radiological image processing software for...

The world's first FDA cleared solution that automatically analyzes bone, muscle, visceral fat, subcutaneous fat, internal organ, and central nervous system in whole-body CT Validation...

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)...

We’re here to bring direct contact back into MIS, with digital hand tops that extend the human hand far into the anatomy. Our handheld...