Perimeter Medical Imaging AI's Claire has become the first FDA-approved AI imaging device for real-time breast cancer surgical margin assessment, aiming to cut the roughly 20% repeat-surgery rate in breast-conserving procedures.
Paige's PanCancer Detect AI, now covering 40 tissue and organ types, has received FDA Breakthrough Device Designation, the first such status awarded to a multi-cancer digital pathology screening tool.
UpDoc Inc. received FDA 510(k) clearance for a diabetes management chatbot built on a large language model, the first cleared medical device to let patients converse directly with a generative AI agent.
The FDA announced on April 28, 2026 a pilot with AI firm Paradigm Health covering trials run by Amgen and AstraZeneca, with the agency's chief AI officer estimating real-time data flows could shave 20 to 40 percent off trial timelines.
A Cleveland Clinic study of 4,000 clinicians found 60% said an ambient AI scribe increased their likelihood of staying in practice, with 97% reporting overall satisfaction with the tool.
A University of Toronto-led study finds that of 1,357 FDA-cleared AI medical devices, only three have ever been tested on whether they improve patient outcomes like survival or hospitalization.
a2z Radiology AI's newly FDA-cleared tool flags seven acute conditions from a single abdomen-pelvis CT scan, and the startup says it cut radiologist reporting time by 17.8% in testing.
Leica Biosystems' newly FDA-cleared Aperio iQC DX caught up to 24% more slide defects than histotechnicians while cutting manual quality-review time by 69%, the company says.
A Nature paper from Nobel laureate David Baker's lab shows generative AI can design antibodies from scratch with atomic-level precision, bypassing the immune system entirely.
A retrospective Swedish study published in Radiology found that three commercial AI-CAD systems could have flagged subtle breast-cancer signs on mammograms years before radiologists caught them clinically.