Reclassification Order Spurs FDA To Update Computer-Assisted Detection Devices Guidance

To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.

3d rendering ai robot analyze x-ray brain tomography

US regulators have updated a guidance that details what software developers should consider when developing products used to detect anomalies in medical imaging, in response to an upcoming new order reclassifying medical-image analyzers.

The US Food and Drug Administration on 21 January republished its guidance on clinical performance for computer-assisted detection (CADe) devices used in radiology. The document was finalized in 2012 after the agency published a 2009 draft of the document following feedback from experts and the public. (Also see "US FDA explains clinical study, pre-market requirements for computer-assisted detection devices" - Medtech Insight, 6 July, 2012

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

More from Regulation

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By 

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

More from Policy & Regulation

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By 

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.