1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics

Ex-FDA Commish Warns Of ‘Limbo’ For COVID-19 LDTs Granted Emergency Use Authorization

Gottlieb cautions in tweets that a new policy by the HHS to remove FDA oversight of lab developed tests “is broader than COVID. It covers any LDT”

 
• By Shawn M. Schmitt

Scott Gottlieb took to Twitter on the morning of 22 August to question the wisdom of a move this past week by the US HHS to strip away the FDA’s oversight of laboratory developed tests for the novel coronavirus.

Scott Gottlieb

In a series of tweets on 22 August, former US Food and Drug Administration commissioner Scott Gottlieb questioned the wisdom of a recent move by the Department of Health and Human Services (HHS) to remove the FDA’s oversight of laboratory developed tests (LDTs) for COVID-19.

The HHS said on 19 August that LDT makers no longer need to notify the FDA before sending their...

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 Diagnostics

Stealth Mode AI Imaging Startup Faction Imaging Raises $10M

 
• By Natasha Barrow

Faction Imaging has come out of stealth mode following six years of research and development studying medical imaging workflows in India, Japan and the US.

GE HealthCare Launches Intraoperative Ultrasound Product Series: bkActiv S

 
• By Natasha Barrow

GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.

Philips Deals Itself A Strong Hand In POCUS Stakes

 
• By Ashley Yeo

Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

More from Device Area

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
• By Marion Webb

SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.