Regulation
The algorithms are used to detect valvular heart disease.
The company is also recruiting a CEO in the US.
Also, See-Mode has received the first US FDA approval for a thyroid ultrasound analysis AI solution.
Digital Therapeutics Alliance CEO joins FDA Digital Health Advisory Committee and more digital heal…
Arrive AI appoints a former Elevance Health executive to its board, and CareAbout Health hires a seasoned digital health executive to be its new chief technology officer.
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.
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.