Regulation

The AI-enabled hearing aids automatically adjust to an individual's hearing needs without configuration.

The White House plan for "safe, secure and trustworthy" artificial intelligence wants the Department of Health and Human Services to have a mechanism in place to collect reports of "harms or unsafe healthcare practices," and act to remedy them.  

The FDA clarifies its interpretation of "more effective," and indicates it will consider improved accessibility of a device during the Breakthrough designation process.

The smartphone-sized device offers continuous monitoring of respiration rate while allowing patient mobility.

The agencies contacted 130 health systems and telehealth providers by mail to emphasize the potential HIPAA risks of using Meta/Facebook pixel and Google Analytics tracking tools that may be "impermissibly disclosing" protected health information.  

The Ohio-based company's XR90 offering allows physicians to view a patient's anatomical structures in 3D for preoperative and intraoperative use. 

The FDA-cleared and CE-marked image analysis software helps providers diagnose and monitor patients with neurological conditions.

BabySat, available via prescription, alerts parents when their baby's heart rate or blood oxygen saturation falls out of a prescribed range.

The company will first use the patent to combine the Apple Watch with Apple's new augmented reality headset Apple Vision Pro for closed loop AI-enabled treatment.

The FDA clearance comes just three months after the company received EU MDR Class IIb certification for its configurable disease management platform.