FDA on track to clear 1,000+ clinical AI algorithms by end of the year

Artificial intelligence sign in the United Imaging booth. The Chinese company wants to break into the U.S. market and has a massive booth footprint at RSNA 2023. This included a section for its own AI development division. Photo by Dave Fornell #RSNA

Artificial intelligence sign in the AI section of the United Imaging booth at the Radiological Society of North America (RSNA) 2023 meeting. The Chinese company wants to break into the U.S. market and has received numerous FDA clearances over the past few months for AI to enhance its imaging systems. Photo by Dave Fornell.

As of July 2024, the FDA reports it has cleared 950 AI algorithms to aid in direct clinical decision making.

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.

Paradise Ultrasound image courtesy of Recor Medical. 

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting.