Leica Biosystems received FDA clearance for Aperio iQC DX, the first standalone AI quality-control tool for clinical digital pathology, which caught up to 24% more slide artifacts than histotechnicians in a Heidelberg University study.
British startup C the Signs is seeking first-of-its-kind FDA De Novo clearance for an AI tool that mines existing medical records to flag cancer risk, after helping identify 75,000 cancer patients across the UK's NHS.
Alibaba DAMO Academy's PANDA AI model, which detects early pancreatic cancer on routine CT scans with 92.9% sensitivity, has received FDA Breakthrough Device Designation after screening more than 70,000 patients in China.
Artera received FDA clearance for ArteraAI Breast, a digital pathology AI tool that scores recurrence risk for HR+/HER2-negative breast cancer patients using existing biopsy images rather than a separate genomic test.
Ibex Medical Analytics won its first FDA clearance for Prostate Detect, an AI pathology tool whose validation data showed it caught prostate cancer in 13% of cases pathologists had initially missed.
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.
Pfizer signed a license agreement with AI biologics startup Chai Discovery on June 4, 2026, gaining access to Chai-3, a model the company says doubled the success rate of therapeutic antibody design over its predecessor.
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.