• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

FDA Awards 510(k) Clearance to Immediate Diagnostic for Pneumothorax

Article

Behold.ai receives approval for red dot® imaging recognition algorithm.

London-based Behold.ai received 510(k) clearance from the U.S. Food & Drug Administration this week for its automatic diagnosis tool for pneumothorax.

Referring to the tool as an “instant triage,” the company said its red dot® algorithm alerts radiologists as soon as it captures a pneumothorax on a X-ray image.

According to a company statement, the tool not only saves reading time, but it can also help reduce the cost of diagnosis when used in conjunction with other products.

“FDA clearance is not just about safety, but also about efficacy,” said Behold.ai Chief Executive Officer Simon Rasalingham, in a press statement. “We believe our technology can make a big difference to patient safety, the delivery of care and cost-savings to the system.”

Based on company information, customers will be charged on a per exam basis, and red dot® will be commercially available in the United States later this year.

Related Videos
Can Fiber Optic RealShape (FORS) Technology Provide a Viable Alternative to X-Rays for Aortic Procedures?
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Can Diffusion Microstructural Imaging Provide Insights into Long Covid Beyond Conventional MRI?
Assessing the Impact of Radiology Workforce Shortages in Rural Communities
Emerging MRI and PET Research Reveals Link Between Visceral Abdominal Fat and Early Signs of Alzheimer’s Disease
Reimbursement Challenges in Radiology: An Interview with Richard Heller, MD
Nina Kottler, MD, MS
The Executive Order on AI: Promising Development for Radiology or ‘HIPAA for AI’?
Related Content
© 2024 MJH Life Sciences

All rights reserved.