3 recent notable approvals of medical AI

Dave Pearson | | Health Exec | Economics
Green Light

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 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.

Related Content

Merck spends up to $2B to license new weight loss drug with potential heart benefits
Insulet wins $452M in lawsuit against rivals over medical device trade secrets
Medical device company cuts 70% of staff in push to meet Medtronic obligations
Cleerly’s momentum continues as AI specialists raise $106M
Operations manager, doctors charged in $70M imaging kickback scheme
Private-equity watchdog warns against nominating Marc Rowan as Treasury Secretary

Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.