18* notable regulatory approvals of emerging technologies over the past 30 days

Dave Pearson | | Health Exec | Economics
Green Light

Along with AI and machine learning, the list may include virtual and augmented reality, 3D printing, robotics and other technologies currently changing healthcare delivery.

1. Avicenna.AI: FDA clearance, CE mark for AI detection, triage of pulmonary embolism, aortic dissection (June 2)

2. Edwards Lifesciences: FDA clearance for AI noninvasive hypotension prediction (June 1)

3. Lucida Medical: CE mark for AI prostate cancer detection (June1)

4. Wyss Center: CE mark for brain-computer interface application for patients with locked-in syndrome (May 28)

5. Advanced Human Imaging: CE mark for AI dermatology diagnostics (May 27)

6. iRhythm Technologies: FDA clearance for AI cardiac arrhythmia detection (May 24)

7. Overjet: FDA clearance for AI periodontal disease diagnostics (May 20)

8. One Drop: CE mark for AI blood glucose forecasting (May 14)

9. GE Healthcare: FDA clearance for deep learning MRI image reconstruction (May 13)

10. Desktop Health: FDA clearance for 3D-printed denture resin (May 12)

11. Whiterabbit: FDA clearance for AI breast cancer diagnostics (May 11)

12. DermaSensor: FDA breakthrough designation for AI skin cancer diagnostics (May 11)

13. Conformis: FDA clearance for 3D knee replacement fitting (May 10)

14. Medo: FDA clearance for AI-optimized thyroid ultrasound workflows (May 6)

15. Genesis Software Innovations: FDA clearance for 3D shoulder surgery planning (May 5)

16. AlgoDx: CE mark for AI sepsis prediction (May 5)

17. Biobeat: CE mark for AI remote patient monitoring (May 4)

18. Exini Diagnostics: CE mark for AI prostate cancer diagnostics (May 3)

*Late addition: 19. Darmiyan: FDA breakthrough designation for AI neurodegenerative diagnostics on MRI (May 28)

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.

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