Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

The US FDA has published warning letters to device firms Integra and Hologic. Both letters recount quality systems issues, with Integra’s centering on sterility while Hologic’s addresses a delay in noting safety signals from the company’s recalled BioZorb markers.

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.

While the UK’s new plan to unlock public health data is a good start, complete, accessible data and regional computational infrastructure are needed to properly train AI for healthcare innovation, AI expert Muhammad Bilal tells Medtech Insight.

Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

Medtech Insight spoke with René Quashie, vice president of digital health at the Consumer Technology Association (CTA), about what to expect at this year’s CES show.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

Our dozen-plus experts from across the medtech sector agreed that 2024 was the year when AI went mainstream. They expect it to continue shaping the sector into 2025 and also hope for increased international harmonization, a more business-friendly US government, and increased investment.

In this first of a two-part series from CES, Medtech Insight tunes into two companies that developed AI-powered cameras to detect respiratory diseases and chronic diseases respectively, two companies offering at-home testing for cholesterol, and a saliva test to help detect symptoms of perimenopause.

The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.