AHRQ Tech Assessment Supports Primary Prevention Implantable Defibrillators

The agency affirms the evidence in favor of implantable defibrillators for primary prevention of sudden cardiac death is strong for patients with reduced left-ventricular ejection fraction, but does not support resynchronization ICDs for this population.

A new Agency for Healthcare Research and Quality technology assessment on implantable cardioverter defibrillators finds strong evidence supporting implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death.

The studies evaluated for the assessment, released Aug. 19, show that ICDs reduce all-cause mortality and sudden cardiac death, compared...

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 Policy & Regulation

Oura Gets Competitors Banned From US Market, But Faces Ultrahuman Countersuit

 
• By 

The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.

A Decade Of Breakthrough Devices: Cardiac And Orthopedic Products Dominate FDA Designations

 

The US FDA has provided an update on its breakthrough devices program, now 10 years running. Cardiac, orthopedic, and neurological devices have received the most designations, while only one has been awarded to an obstetrics/gynecology product.

Study Finds Public Companies Behind Most Recalled AI Devices

 
• By 

A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.

Four-Year Waits, 60-Page NCDs: Consultant Urges Medicare Overhaul

 
• By 

Medicare’s device coverage process is “a system in crisis,” consultant Bruce Quinn warned at the NextGen Dx Summit. He criticized bloated NCDs, stalled advisory committees, and years-long delays, urging CMS to streamline LCDs and adopt a six-month “fast-track” model to speed innovation access.

More from Medtech Insight

Study Finds Public Companies Behind Most Recalled AI Devices

 
• By 

A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.

Reports Put $4B Price Tag On Versius Maker CMR. Will This Change Surgical Robot Valuation?

 

The value proposition of surgical robots is quickly changing. Gone is the focus on benefit to patients; instead cost, operative efficiency and surgeon longevity are the new focal points, making deciphering M&A value much more difficult.

Four-Year Waits, 60-Page NCDs: Consultant Urges Medicare Overhaul

 
• By 

Medicare’s device coverage process is “a system in crisis,” consultant Bruce Quinn warned at the NextGen Dx Summit. He criticized bloated NCDs, stalled advisory committees, and years-long delays, urging CMS to streamline LCDs and adopt a six-month “fast-track” model to speed innovation access.