Regulation

Ben Wolf, partner in Alston & Bird's Health Care Group, told MobiHealthNews how FDA staffing cuts could slow device approvals and what companies can do to stay ahead.

The judge ruled that the FDA overstepped its authority by regulating LDTs as medical devices, overturning the rule and remanding it to the HHS Secretary for review.

The lack of a strong set of AI-specific regulation in the U.S. allows innovation to happen quickly, but that also requires companies to be transparent and for the industry to take responsibility for its own actions, says Mika Newton, CEO of xCures.  

Also, two Korean digital dentistry solutions providers are integrating AI into their dental diagnostic software.

The company will use the funds to accelerate commercial expansion of its ANNE One medical wearable in the United States and Europe.

The company has secured 510(k) clearance for its Apple Watch-powered seizure monitoring platform, expanding the role of wearables in epilepsy care.

Leaders of government public policy at HIMSS are prioritizing health equity, AI regulation, cybersecurity and workforce development while urging unified policies that support healthcare innovation.

The Global Digital Health Partnership works to foster international collaboration to strengthen digital health infrastructure, interoperability and system resilience globally.

The AI-enabled technology detects a lack of pulse, confirms the condition using motion sensors and infrared signals, and automatically alerts emergency services if needed.

The firings included 20 individuals in the FDA's Office of Neurological and Physical Medicine Devices.