EClinCloud Analysis Reviews 1,715 FDA Inspection Citations
EClinCloud found that protocol compliance, informed consent and investigator case histories accounted for 46.2% of citation occurrences in FDA inspection data from fiscal 2020 through 2025.
Applications of AI in healthcare, including medical diagnostics, drug discovery, patient care solutions, and biotechnology research.
EClinCloud found that protocol compliance, informed consent and investigator case histories accounted for 46.2% of citation occurrences in FDA inspection data from fiscal 2020 through 2025.
DarioHealth will release its third quarter 2026 financial results before the market opens on November 12, followed by a conference call and webcast.
Pure Charge&Go MaX is now available through the US Department of Veterans Affairs, Department of Defense and Indian Health Service.
Covera Health named Jeremy Livianu chief legal officer and Adam Travis general manager of imaging strategy and growth.
Asteromorph has opened a biological laboratory in Hwaseong, South Korea, to test scientific hypotheses and treatment strategies generated by AI.
NAMI will help develop standards for how AI products respond when young people experience suicidal ideation, psychosis, or other severe mental health crises.
Midstream Health raised a $20 million Series A led by Valtruis, with Andreessen Horowitz returning, for agentic AI that recovers money hospitals are owed.
An AI agent selected a gene therapy and controlled robotic equipment to inject it into the brain of a live mouse, with a veterinary surgeon performing the craniotomy.
A patient alleges that Allegheny Health Network and Highmark failed to obtain informed consent before an Abridge tool recorded and processed confidential medical conversations.
GPT-Rosalind-6 uses the same weights as GPT-6 Astra and is available through trusted access for approved life sciences research.
Two surveys found widespread AI chatbot use among children and teens, including for schoolwork and emotional support. Some uses were associated with poorer mental health, but the findings do not establish causation.
Susan Feinberg alleges ChatGPT and Replika contributed to her husband's death in June 2024. The lawsuit seeks punitive damages and a jury trial.
Canadian privacy regulators are urging governments to require privacy protections, oversight and accountability for AI systems used in health care and health research.
The 53 member states of the WHO European Region adopted a shared roadmap for integrating artificial intelligence into health systems through 2033.
SpendRule raised $4 million in seed funding for its AI platform, which checks vendor invoices against contract terms and flags potential overpayments.
A Pew Research Center survey finds Americans are open to AI handling some healthcare tasks, but most want human review and remain uncomfortable with its use in diagnosis and treatment.
Kipu Health has released agentic AI capabilities on Kipu Helix, including an agent that prepares continued stay reviews while requiring human approval for payer submissions.
Google is expanding its health AI work in Singapore with a new research hub, clinical tools and population health programs. Google.org and Google DeepMind are also contributing $7 million to a regional health coalition.
ALLOX raised $10.5 million in seed funding to expand its drug discovery platform and advance its small molecule research programs.
Flagship Pioneering formed Etcelera by combining Cellarity, Etiome and Empress Therapeutics into an AI drug discovery company.
Weekly coverage of AI applications in healthcare, drug development, biotechnology research, and genomics breakthroughs.