Public Policy
The Act is the world's first major law for AI implementation and provides regulations for high-risk applications of the technology, including its use in healthcare.
The t:slim X2 Pump is compatible with Dexcom G7 and G6 continuous glucose monitoring systems and was cleared for sale by Health Canada.
The proposed 2025 physician fee schedule from the Centers for Medicare & Medicaid Services includes payment and coding for digital health tools for behavioral health.
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.