Iterative Health Raises $77 Million for AI-Driven Clinical Research 🔗

Iterative Health raised $77 million in a round led by Google Ventures and Intrepid Growth Partners to expand its AI-powered clinical research platform. The company operates a network of over 100 research sites across four continents, with partnerships spanning more than 40 sponsors, CROs, and biotech companies. The platform centralises site access and uses AI to match patients with trials, improving activation rates and enrollment. Iterative plans to use the funding to extend coverage into cardiology and obesity, where FDA and EMA pressure for diverse trial populations is increasing. Current therapeutic focus is gastroenterology and hepatology.

Aidoc Closes $150 Million Series E 🔗

Aidoc raised $150 million in a Series E round, bringing total funding above $500 million. The company's CARE foundation model holds 17 FDA-cleared algorithms and is deployed in nearly 2,000 hospitals, analysing over 60 million patient cases annually. The new capital will fund global expansion of the aiOS platform and automation of imaging draft report generation. CEO Elad Walach framed the goal as AI supporting every complex diagnostic decision by 2030.

Mayo Clinic AI Detects Pancreatic Cancer 16 Months Before Diagnosis 🔗

Mayo Clinic published results in the journal Gut for REDMOD, a model that detects early signs of pancreatic cancer in routine abdominal CT scans initially reported as normal. In a study of nearly 2,000 scans, REDMOD identified 73% of cancers with an average lead time of 16 months before clinical diagnosis, roughly doubling detection rates compared to radiologists without AI support. The model uses radiomics to detect tissue texture changes invisible to the human eye and integrates automatically into existing imaging workflows without additional procedures.

EU AI Act Omnibus Negotiations Collapsed Without Agreement 🔗
The April 28 trilogue on the EU AI Act Omnibus failed to produce an agreement. The central dispute: whether AI systems embedded in products already covered by existing EU safety legislation, including medical devices and IVD frameworks, should be exempt from additional AI Act requirements. The European Parliament backed these exemptions. The Council and Commission opposed them. The next trilogue is scheduled for mid-May. The enforcement deadline for high-risk AI systems remains August 2026.

The signal: Every AI diagnostics company selling into Europe is directly affected by how this resolves. The difference between being classified as high-risk under the AI Act or relying solely on existing MDR and IVD frameworks determines documentation requirements, transparency obligations, and conformity assessment pathways. Companies currently in certification processes may be building to a moving target. The outcome of the May trilogue is one of the most operationally significant regulatory decisions of the year for this sector.

Pistoia Alliance: 30% of Organisations Claim Enterprise AI. 69% Cannot Measure Its Value 🔗

A Pistoia Alliance survey presented at its European conference, with participants from Roche, AstraZeneca, and the FDA, found that while 30% of life sciences organisations report enterprise-wide AI implementation, 69% have no metrics demonstrating impact on cost or timeline. Only 1% of respondents reported AI delivering value specifically in wet lab environments. A parallel Deloitte survey found that only 9% of life sciences leaders reported substantial ROI from AI.

The signal: These numbers sit in direct tension with the deal values above. The industry is writing billion-dollar checks for AI platforms while the majority of organisations that have deployed AI cannot demonstrate what it returned. This may indicate that AI value in life sciences is concentrating in a small number of large-scale platform deployments while most enterprise implementations remain poorly scoped and unmeasured. The next signal to watch: whether ROI measurement becomes a procurement requirement rather than a post-deployment aspiration.

More Than Half of All Registered Clinical Trials Are Now Run Entirely Overseas 🔗

As of February 2026, over 50% of registered clinical trials were conducted solely outside the United States, compared with 29% run exclusively within the US. The primary driver is China, where drug approval timelines from early discovery to IND are 50% to 70% shorter than in other regions, and later-stage patient recruitment runs two to five times faster. The FDA's ongoing acceptance of foreign clinical data makes this trend self-reinforcing for US and UK sponsors.

The signal: This is a structural shift with direct consequences for clinical trial software vendors. Site activation tools, patient recruitment platforms, EDC systems, and CTMS deployments that are built around US and EU regulatory assumptions are now serving an increasingly international trial footprint, with different data standards, language requirements, and inspection frameworks. Vendors who treat China and Asia-Pacific market compliance as optional features are pricing themselves out of a growing share of the market. The geography of trials is changing faster than the software designed to run them.