1. Medtech Insight
  2. >>Digital Technologies

US FDA Commish Defends Approach To Apple Approvals

After industry stakeholders raised concerns that Apple may have received preferential treatment when US FDA approved heart-rhythm apps on the Apple Watch Series 4, Commissioner Scott Gottlieb states in a blog post that the agency's approach was in accordance with its standard procedures and reflect the benefit of early interaction with FDA.

Commissioner Gottlieb speaking at RAPS 2017
Scott Gottlieb • Source: Ferdous Al-Faruque

After stakeholders in the medical device industry raised concerns that Apple may have been given preferential treatment to get two de novo classifications in record time, FDA Commissioner Scott Gottlieb penned a lengthy blog post defending the agency's decisions and argued the de novo approvals met the agency's standard review procedures.

Earlier in the month, Apple announced during the launch of its new watch it had received de novo classifications for apps on the device. One of the de novo applicationswas for an app that functions as an electrocardiogram (ECG) while the other is for an algorithm software that is intended to let users know if they are at risk for atrial fibrillation or afib. The reviewers took 30 days from submission to decision and they were completed the day prior to Apple's big launch date for the new watch

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 Digital Technologies

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.”

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

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 Medtech Insight

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.