Notable regulatory approvals of emerging technologies over the past 30 days

Dave Pearson | | Health Exec | Economics
Green Light

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 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

Cardiologist sues health system over gender discrimination, unequal pay and hostile treatment
FTC, DOJ and HHS release report warning of private equity consolidation in healthcare
Q&A: Vulnerable patients hit hardest by anesthesia reimbursement cuts
Momentum continues for renal denervation as CMS considers national Medicare coverage
Johnson & Johnson buys depression drug and its manufacturer for $15B
UnitedHealth, Amedisys ask federal judge to dismiss DOJ lawsuit blocking $3.3B merger

Around the web

Cardiovascular Business
Biden chooses semaglutide for next round of Medicare price negotiations—Trump gets final say

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%. 

AI in Healthcare
4 ways HHS plans to help shape a national strategy for healthcare AI

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.

Cardiovascular Business
FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries.