1. Medtech Insight
  2. >>Archive

US FDA drafts guidance on computer-assisted detection devices

 
• By Vibha Sharma

The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.

The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.

One of the documents provides recommendations relating to premarket notification submissions (ie the “510(k)” process)2; the other contains recommendations on how to design and conduct clinical studies of these devices3, which are computerised systems that incorporate pattern recognition and data analysis capabilities intended to identify, or direct

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

More from Medtech Insight

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 
• By Natasha Barrow

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.

A Deregulated Medtech Sector Could Flourish In Merz’s Industry-Friendly Germany

 
• By Ashley Yeo

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.