Regulation
LifeSemantics plans to commercialise its mobile app-based AI screening solution by yearend.
The company's Dream Sock, which received FDA 510(k) clearance in November, gathers real-time health readings, including a baby's sleep trends and pulse rate.
The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.
The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.
They had been designated as innovative medical devices.
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.
Digital health leaders say frameworks already exist that can be adopted for AI regulation, but going too far with rules could stifle innovation.