The FDA cleared 14 AI/ML-enabled medical devices in Q2 2026, including De Novos and 510(k)s, spanning neurology, cardiology, radiology, and other specialties. Key clearances include neuropacs' MSAp/PS…
The FDA released the draft MDUFA VI commitment letter for FY2028–2032, introducing structural changes to how sponsors interact with the agency, including faster pre-submission feedback, a permanent au…
Utah launched the nation's first AI-powered prescription refill program in January, partnering with startup Doctronic to let a chatbot renew about 190 chronic medications, as states move to license AI…
Utah launched a prescription refill program using an AI chatbot called Doctronic, allowing residents to get refills without seeing a doctor. The program has sparked debate among doctors and experts ab…
Google Research is using AI to accelerate scientific discovery across genomics, neuroscience, epidemiology and climate science, according to Lizzie Dorfman, who leads science AI at the company. Dorfma…
Midjourney released a behind-the-scenes video of its full-body ultrasound scanner, showing the machine's hardware assembly but not providing clinical validation data. CEO David Holz said the company's…
UpDoc debuted the first FDA-cleared patient-facing clinical LLM on June 25, 2026, for insulin management in type 2 diabetes. The device, cleared via 510(k) K253281, provides voice or text insulin titr…
Researchers introduced ATHENA-R1, an AI agent trained via reinforcement learning over 212 biomedical tools to perform treatment reasoning across all FDA-approved drugs since 1939. The agent achieved 9…
A wave of bipartisan federal bills is targeting how AI companies collect and monetize personal health data, threatening the business models of digital health startups that rely on selling user data. S…
Researchers developed a provenance-aware, knowledge-graph-based multi-agent framework that integrates 466,525 Reddit posts, 60,782 WebMD reviews, and 20 years of FDA adverse event data for nine antide…
UpDoc announced on June 25, 2026, that its AI platform received FDA clearance as the first FDA-cleared clinical AI agent and LLM-enabled device, though public records show the clearance (K253281) is f…
ARPA-H is selecting teams this month to build the first FDA-authorized agentic clinical AI system, ADVOCATE, which will autonomously write prescriptions, adjust medications, and provide 24/7 cardiovas…
A study led by Harvard and Stanford researchers found that ChatGPT outperformed hundreds of physicians in diagnostic challenges, sparking concerns about AI's rapid integration into U.S. healthcare wit…
Montreal-based surgical AI company Reveal Life Science won first place in the OVHcloud Startup Challenge at VivaTech 2026 in Paris. The company uses Raman spectroscopy to analyze tissue molecular sign…
Canadian medical AI startup Reveal Life Science won first place in the OVHcloud Startup Challenge at VivaTech in Paris, beating dozens of international competitors. The company's AI platform uses Rama…
Midjourney, the AI lab known for image generation, announced a healthcare project called Midjourney Medical, featuring an underwater full-body ultrasound scanner that can create 3D body maps in 60 sec…
Midjourney, known for AI imagery, announced plans to build a cheaper, faster body scanner using ultrasonic sensors and open a spa in San Francisco by 2025, aiming to collect health data and eventually…
Midjourney, the AI image generator, announced it is developing a full-body ultrasonic scanner that can scan a body in 60 seconds, and plans to open spas housing the machines. The company is partnering…
Midjourney announced a full-body ultrasonic CT scanner and a spa venture in San Francisco, aiming to revolutionize medical imaging with a device that uses 358,000 ultrasonic elements and claims 0.5mm …
Midjourney CEO David Holz unveiled the company's first hardware product, the Midjourney Scanner, a full-body ultrasound scanner developed with Butterfly Network. The device uses 40 ultrasound modules …