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Clinical labs and diagnostics firms alike are still grappling with the likely impact of the FDA’s final rule on LDTs, speakers said in a recent webinar. Key areas of concern: The potential for lab consolidation, lack of clarity on when clearance is necessary, research-use tests, and the hesitation imposed by an ongoing lawsuit and upcoming election.

The US FDA’s Patient Engagement Advisory Committee met Wednesday to discuss ways the agency can empower patients thinking about whether to participate in clinical trials of regulated medical products. Central to the committee’s discussion was not only the type of information patients need to evaluate when considering joining a study, but how that information should be presented to them.

Recognizing October as cybersecurity awareness month, the US FDA has added new publications to its list of resources concerning the cybersecurity of medical devices.

The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.

Clinical labs and diagnostics firms alike are still grappling with the likely impact of the FDA’s final rule on LDTs, speakers said in a recent webinar. Key areas of concern: The potential for lab consolidation, lack of clarity on when clearance is necessary, research-use tests, and the hesitation imposed by an ongoing lawsuit and upcoming election.

The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.

Medtech Insight talked with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH about the firm’s new CareIntellect for Oncology offering to help clinicians make efficient use of multimodal patient data, his vision for projects within AI Innovation Lab, and the future of AI in health care.

University of Cambridge's soon-to-be spun-out Nimble Genomics is among grant-winning projects in Capital Enterprise's Cancer Tech Accelerator. Medtech Insight spoke to clinical oncologist and Nimble founder Henno Martin and co-founder Radek Lach to learn more what about the brain cancer blood test’s prospects in an increasingly competitive liquid biopsy space.

After more than 20 years in patient care, cardiologist Ethan Korngold became chief medical officer for Abbott’s vascular business in April. How was his first conference on the industry side of the table? “Incredibly invigorating,” he said, offering updates on Abbott’s Ultreon and Esprit BTK product lines.

Medtech Insight talked with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH about the firm’s new CareIntellect for Oncology offering to help clinicians make efficient use of multimodal patient data, his vision for projects within AI Innovation Lab, and the future of AI in health care.

After more than 20 years in patient care, cardiologist Ethan Korngold became chief medical officer for Abbott’s vascular business in April. How was his first conference on the industry side of the table? “Incredibly invigorating,” he said, offering updates on Abbott’s Ultreon and Esprit BTK product lines.

At HLTH 2024, GE HealthCare unveiled CareIntellect for Oncology, a generative AI-driven platform to help oncologists quickly assess patient data across multiple sources to save time and improve treatment planning. The platform, currently in evaluation at two US hospitals, is set for launch in the second half of 2025.