Regulatory Updates

Stay compliant with the latest FDA announcements, AI/ML guidance documents, and healthcare regulations affecting AI in medicine.

Featured Regulatory Updates

Important regulatory announcements and guidance documents

FeaturedRegulatory UpdateFDA

FDA 510(k): Global Hypoperfusion Index (GHI) Algorithm

Summary

Edwards Lifesciences, LLC

Jul 26, 2023

FeaturedRegulatory UpdateFDA

FDA 510(k): Smart Wedge algorithm

Summary

Edwards Lifesciences, LLC

Aug 18, 2023

Regulatory UpdateFDA

FDA 510(k): Omnipod 5 algorithm

Summary

Insulet Corporation

Dec 3, 2025

Regulatory UpdateFDA

FDA 510(k): ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

Summary

Anumana, Inc.

Regulatory UpdateFDA

FDA 510(k): Hypertension Prediction Index (HePI) Algorithm

Summary

Edwards Lifesciences, LLC

Regulatory UpdateFDA

FDA 510(k): Cerebral Autoregulation Index (CAI) Algorithm

Summary

Edwards Lifesciences

Regulatory UpdateFDA

FDA 510(k): CAC (gated) Algorithm

Summary

BunkerHill Health

Regulatory UpdateFDA

FDA 510(k): Edwards Algorithm for Measurement of Blood Hemoglobin

Summary

Edwards Lifesciences, LLC

FeaturedRegulatory UpdateFDA

FDA 510(k): Smart Wedge algorithm

FeaturedRegulatory UpdateFDA

FDA 510(k): Global Hypoperfusion Index (GHI) Algorithm

Regulatory UpdateFDA

FDA 510(k): EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM

Summary

Deltamed GmbH

Regulatory UpdateFDA

FDA 510(k): STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING

Summary

Straumann USA

Showing 1 to 10 of 15 results

Page 1 of 2