Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements ...

Moon Surgical today announced it received FDA 510(k) clearance for two new features on the Maestro surgical robot.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management ...

The FDA decision also included a Predetermined Change Control Plan (PCCP), enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats and ...

BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S.

Press Release DESKi, a healthtech company developing AI-powered diagnostic tools in collaboration with clinicians and researchers, today announced the close of a $6 million seed round to support the U ...

This milestone builds on growing momentum for HeartFocus, which recently received FDA clearance, along with a Predetermined Change Control Plan (PCCP) that makes it easier to update and expand the ...

Funding follows FDA clearance and landmark trial validating novice-led cardiac imaging. DESKi closes $6M seed round thanks to Racine², ... (PCCP) for HeartFocus’ growth opportunities.

This milestone builds on growing momentum for HeartFocus, which recently received FDA clearance, along with a Predetermined Change Control Plan (PCCP) that makes it easier to update and expand the ...