Medicine, biotech & longevity04 Nov 2026 · 2 min
AI in medicine and longevity: approvals, trials, limits
AI · not reviewedWritten with AI from the sources listed, not yet editorially reviewed.
The US FDA is authorising more AI medical devices than ever and AI-designed drugs are reaching late-stage trials — the evidence for “rejuvenation” remains preliminary.
The essentials in five points
- The FDA authorised 331 AI-enabled medical devices in 2025, more than ever; in total, more than 1,400 are on its list, most of them in radiology.
- Insilico’s AI-designed drug rentosertib for pulmonary fibrosis lowered biological age, as estimated by proteomic clocks, by about three to four years in one dose group after four weeks in a phase IIa trial with 42 participants (Nature Biotechnology, 2026).
- Those involved name the limits themselves: the trial was small, the age values come from predictive models, and it cannot separate slower ageing from a treated lung.
- Isomorphic Labs, Alphabet’s AI drug-discovery company, expects its first clinical trials by the end of 2026 — later than first announced.
- In the EU, AI medical devices fall under Annex I of the AI Act; after the omnibus, their high-risk obligations apply from 2 August 2028.
What this means for businesses
For hospitals, labs and investors, AI in imaging is routine, in drug discovery on its way into late-stage trials — and in longevity still research with preliminary biomarkers. When investing or partnering, check whether efficacy is shown on clinical endpoints, not only on ageing clocks.
Sources · 4
- MedTech Dive · 27 May 2026AI in medtech: tracking new devices cleared by the FDA
- News-Medical · 07 Sept 2026AI-designed drug candidate reverses biological age in clinical study
- IntuitionLabs · 09 Aug 2026Isomorphic Labs & AlphaFold: AI Drug Discovery in Trials
- A&O Shearman · July 2026EU Digital Omnibus on AI: the wait is over but the compliance clock is running
Links open the original source in a new tab. Figures from company statements are labelled as vendor or company figures in the text.
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