Diagnostics
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.
The FDA's new draft guidance for pulse oximeters requires developers to demonstrate device effectiveness across diverse skin tones to address accuracy issues, especially for people with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.
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.
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.
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?
Jonathan Kamerman, ambulatory monitoring and diagnostics, national sales leader at Philips, discusses leveraging and managing patient data to solve hospital pressure points.
Bayer Consumer Health snaps up digital therapeutic Cara Care for its Precision Health business with an eye to developing its self-care capabilities.
Nvidia shows its commitment to developing AI capabilities in Vietnam with VinBrain acquisition and two new AI research and data centers.
Santhosh Nair, president of Thermo Fisher Scientific's ImmunoDiagnostics , talks to Medtech Insight about Thermo Fisher's "secret sauce,” the Allergon company, and what is next for Thermo Fisher.
A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.
Patient safety group ECRI put AI-enabled applications at the top of its annual list of health hazards for 2025. The group says that despite its enormous potential, artificial intelligence presents the most significant risk among health technologies going into the new year.
Keep an eye on next year’s over-the-counter drug user fee negotiations for insights into the incoming Republican administration's approach to device regulation, attorneys said in a recent webinar. Other areas to watch include AI and diagnostics regulation, with potential bipartisan agreement on AI oversight
A Medtronic-funded study will use Tempus’ Next Cardiology platform to identify aortic and mitral heart valve disease patients who are being undertreated.
During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.