1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Approvals

Dexcom Works With FDA To Bring CGM To Hospitals After Pandemic

 
• By Reed Miller

The FDA gave Dexcom and Abbott emergency permission to provide their continuous glucose monitoring systems to hospitals to be used by inpatients and hospital staff. Now the agency has granted Dexcom its breakthrough designation to accelerate the approval of Dexcom’s system for the in-hospital indication.

hospital cartoon
• Source: Alamy

The US Food and Drug Administration signaled its interest in helping to bring continuous glucose monitoring to hospital inpatients by granting its breakthrough device designation to DexCom’s continuous glucose monitoring system.

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 Approvals

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By Elizabeth Orr

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.

Quibim Extends Into US Market With FDA Authorization Of QP-Prostate CAD

 
• By Natasha Barrow

The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.

More from Policy & Regulation

Biotech Leader Predicts Delays On Device Approvals As FDA Makes Life-Saving Drugs Sole Priority

 
• By Natasha Barrow

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By Elizabeth Orr

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.