Medical Devices

The safety nonprofit says artificial intelligence models that aren't properly evaluated and deployed are a big concern for 2025. Others include home health technology and hospital infusion system vulnerabilities.

Also, the South Korean government will pilot an electronic system to maintain the patient medical records at shuttered health facilities. 

The agency said it will review developers' modified Predetermined Change Control Plans for artificial intelligence and machine learning submissions that have already been approved without triggering the need for new marketing submissions.

As RSNA kicks off in Chicago, here's a roundup of some recent radiology and imaging IT announcements.

The announcement comes about four months after Musk relayed his vision for patients with an Optimus robotic arm or leg to have the ability to control their limbs with the N1 implant.

Anahi Santiago, chief information security officer at ChristianaCare, says the architecture to develop security programs is shifting as providers manage a larger number of partners in the supply chain and in hospital at home programs.

The Health Promotion Board is piloting two preventative health programmes with Google and Abbott involving 6,000 Singaporeans.

Nearly half of FDA-approved AI medical devices haven't been trained on real patient data. Dr. Jay Anders, chief medical officer at Medicomp Systems, offers solutions to this challenge, and explains problems with using synthetic data.

In a letter to the FDA, members of Congress cite confusion over providers' deployment of clinical decision support software that is exempt from medical device regulations and call for clarity from its Center for Devices and Radiological Health.

Also, Australia's aged care research centre has received additional funding to deploy AI.