Regulation

Epitel received 510(k) clearance for two remote monitoring offerings and Curio Digital Therapeutics received clearance for its postpartum prescription digital therapeutic.

The Eko Low Ejection Fraction Tool will be added to the company's cardiac early detection platform, which already includes various algorithms to inspect heart health.

The digital cytology system helps identify cervical cancer cells and precancerous lesions using deep learning AI and volumetric imaging technology.

Novii+ allows for continuous monitoring of high-risk pregnancies after 34 weeks, and alerts care teams of heart rate and contraction patterns during labor.

Amazon Web Services chief medical officer Dr. Jared Saul relays how AWS helps the life sciences sector leverage AI and machine learning for drug discovery, concerns around AI/ML use in healthcare, and the value of regulating the technology.

Digital health leaders say frameworks already exist that can be adopted for AI regulation, but going too far with rules could stifle innovation.

Jay Rughani, investment partner at a16z, discusses 2023 events, predictions for digital health funding in 2024 and proper AI regulation to avoid stifling innovation.

Boston Children’s, CVS, Geisinger, UC San Diego and Wellspan are among the 28 providers and payers promising their AI and machine learning models are geared to ensure healthcare outcomes that are "Fair, Appropriate, Valid, Effective and Safe."  

The kit was determined to be comparable to a device used in clinically-administered intrauterine insemination.

Dr. Michael Howell, chief clinical officer at Google, discusses Med-PaLM's evolution in 2023 and recommendations for regulators developing rules for AI use in healthcare.