Device Area

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.

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.

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.

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.

Medtech Insight brings you the highlights from two panel discussions at CES 2025 featuring innovators in the neurotech space discussing opportunities, challenges and ethical considerations in developing AI-driven solutions for the brain, and what lies ahead.

Despite over 27,000 individuals now named as persons responsible for checking EU regulatory compliance of manufacturers’ medtech products, there is still a lack of oversight of this comparatively new role as well as other teething issues.

The US FDA final guidance uses a Q&A format to help manufacturers navigate the regulatory landscape for communicating the off-label uses of their medical products to health care professionals. However, some say the final document fails to address potential free speech concerns.

The FDA's new draft guidance for pulse oximeters requires developers to demonstrate device effectiveness across diverse skin tones to address accuracy issues, especially for people with darker skin. The guidance includes clinical study requirements, labeling changes, and recommendations for comparing new devices to predicates.

The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.

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.

AI diagnostic biotech startup Owkin says AI adoption in digital pathology is slower than in radiology. In a new report, it identifies reimbursement structures and lack of funding and operational resources as barriers to faster adoption.

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.

As part of its Home as a Health Care Hub initiative, the US FDA’s device center has unveiled an Idea Lab that includes a virtual reality experiencing offering an inside look at what is possible for patients receiving care at home utilizing the latest digital technologies.

Scotland has a strong foundation of medtech research, but to reach the ‘tipping point’ where it has gained critical startup mass, it must overcome funding challenges and foster corporate startup partnerships.

Jerome Trividic, CEO of Swiss company Spineart, believes that by solving pain points felt by orthopedic surgeons performing spinal procedures, it can improve patient outcomes. He thinks the firm’s innovative approach, which focuses on partnership deals as well as developing its own products, will give it a competitive edge in the spinal surgery market.

EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?

Dexcom invests $75m in ŌURA, cementing a data-sharing partnership with the smart ring developer.

Jonathan Kamerman, ambulatory monitoring and diagnostics, national sales leader at Philips, discusses leveraging and managing patient data to solve hospital pressure points.