House Bill Clarifies CDRH Lead For New Imaging Indications For Devices Using Contrast

Rep. Ryan Costello, R-Pa., and Scott Peters, D-Calif., recently introduced legislation clarifying that the US FDA device center, rather than the drug center, will have primary authority to consider and clear new indications for imaging devices and technologies that use previously approved contrast agents.

The US imaging equipment and contrast-agency industries are touting a recently introduced US House bill that lobby groups say would provide "a clear regulatory pathway" for imaging device manufacturers to win clearances for new indications of their products involving formerly approved contrast agents.

H.R. 2009, the "Fostering Innovation in Medical Imaging Act of 2017" was introduced April 6 by Reps. Ryan Costello, R-Pa. and Scott Peters, D-Calif., and referred to the House Energy and Commerce Committee for consideration

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 Diagnostic Imaging

‘Pathologists Are Hungry For AI-Enabled Digital Pathology’

 

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.

The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist

 

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

‘AI Isn’t Flying Off The Shelves In The NHS,’ Says Healthtech Startup CEO

 

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI. Haris Shuaib, CEO of Newton's Tree, shared his insights with the audience at the “Next Frontier of Medical AI” event held at DAC Beachcroft's London office on 23 April.

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

More from Diagnostics

Danaher Faces $350M Tariff Hit, But Says It’s Ready To Absorb The Blow

 
• By 

Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.

What’s A Diagnostic? WHO Wants To Know

 
• By 

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.

‘Pathologists Are Hungry For AI-Enabled Digital Pathology’

 

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.