1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics
  4. >>In Vitro Diagnostics

Labs, Test Makers Urge Congress To Pass Diagnostic Reforms

 
• By Sue Darcey

More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.

tubes

Test manufacturing and laboratory groups are pushing Congress to move forward with legislative reforms on US FDA and Centers for Medicare and Medicaid Services regulatory oversight of lab developed tests (LDTs) and IVDs this summer, a topic that has been sitting on the back burner of key congressional committees for several years now.

Last year in March, Reps. Larry Bucshon, R-Indiana, and Diana DeGette, D-Colorado, of the House Energy and Commerce Committee came up with a plan for regulating diagnostics, outlined in discussion draft, called the Diagnostics Accuracy and Innovation Act (DAIA), that many, though not all, industry and lab groups agree is at least a good starting framework. (Also see "Diagnostics Reg Overhaul Floated In US House" - Medtech Insight, 21 March, 2017

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 In Vitro Diagnostics

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

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

 
• By Natasha Barrow

“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.”

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

More from Diagnostics

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

FDA Announces Classifications On 9 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.