3 recent notable approvals of medical AI

Along with AI, this ongoing list includes regulatory clearances of virtual and augmented reality, 3D printing and other emerging technologies targeted for healthcare.

1. DiA Imaging Analysis (Be’er Sheva, Israel, Oct. 29)—FDA 510(k) clearance for AI selection of optimal echocardiogram views. Product: LVivo Seamless

2. IQ-AI (Jersey, Channel Islands, Nov. 4)—FDA 510(k) clearance for software that uses AI to process CT scans for virtual liver biopsy of patients with chronic liver disease. Product: Liver Surface Nodularity/LSN

3. SenseTime (Abu Dhabi, UAI, Nov. 4)—CE certification for AI interpretation of CT scans with suspected lung diseases, including COVID-19. Product: SenseCare-Lung Pro

To see the previous entry in this series, click here.

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.

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Given the precarious excitement of the moment—or is it exciting precarity?—policymakers and healthcare leaders must set directives guiding not only what to do with AI but also when to do it. 

The final list also included diabetes drugs sold by Boehringer Ingelheim and Merck. The first round of drug price negotiations reduced the Medicare prices for 10 popular drugs by up to 79%. 

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.