Notable regulatory approvals of emerging technologies over the past 30 days

Along with AI in its various iterations, the list may include virtual and augmented reality, 3D printing, robotics and other technologies currently changing healthcare delivery.

Interventional Systems: FDA clearance for robotic surgical instrument assistant (June 29)

Neuros Medical: FDA breakthrough designation for high-frequency pain blocking (June 29)

Cibiltech: CE mark for AI kidney transplant management (June 30)

Viz.ai: Ce mark for AI stroke-care coordination (June 30)

DeepLook: FDA clearance for deterministic lesion segmentation and measurement (July 8)

EnsoData: Expanded FDA clearance for AI sleep care (July 14)

Omniscient Neurotechnology: FDA clearance for digital brain mapping (July 21)

Asensus Surgical: FDA clearance for articulating robotic surgery instruments (July 28)

Medtronic: FDA clearance for AI cardiac monitoring (July 28)

Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Trimed Popup
Trimed Popup