1. Medtech Insight

Two Deaths Linked To Philips Recall of Heart Monitoring Software

 
• By Brian Bossetta

A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.

Philips initiated a recall in November of a software application from its subsidiary Braemar Manufacturing after identifying failures to properly route some electrocardiogram (ECG) events.

The US FDA has designated the recall class I, its most serious, and says it is aware of 109 injuries and two deaths related to...

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 Medtech Insight

More from Policy & Regulation

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel