Device Area

Royal Philips has taken a “significant step” in advancing live-data analytics in clinical practice in a new collaboration with US Mass General Brigham. The parties will leverage software platforms to unify EMR, lab and bedside medical devices data.

Anita Jackson is facing 25 years for device adulteration and a host of other charges. She says the trial and appeals court failed to consider her defense.

The digital health market includes thousands of app-based solutions targeting single health conditions, but the cost, complexity and number of options “gives too many opportunities to health care systems to say no,” said Mike Trenell, Daiser CEO. The second generation of digital health might have the answers, he said.

Hologic attains full US Food and Drug Administration 510(k) clearance for its Aptima SARS-CoV-2 assay, which reached market under an Emergency Use Authorization (EUA). Overall, Hologic’s “best-performing” molecular diagnostic business continues to grow despite the decline in revenue for COVID-19 assays and related items.

Researchers from the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Center are testing Digostics’ GTT@home test in children to assess if it offers a better alternative to the clinical gold-standard oral glucose tolerance test.

Boston Scientific has integrated cardiac mapping and pulsed field ablation into a single catheter with the newly EU-approved Farawave Nav Ablation Catheter. Faraview Software also receives CE marking, allowing for visualization of catheter placement when delivering therapy.

The US market’s largest imaging manufacturer marked two years as an independent company with plans to invest in more M&A and PDx production capacity, but reported a modest 2025 revenues outlook.

France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.

PathAI, a Boston-based AI-pathology startup backed by $355m, partners with Brazil’s largest integrated healthcare network to support diagnosis and treatment of cancer patients using its AISight image management system.

Volta Medical’s TAILORED-AF clinical trial demonstrates that AI can achieve "superior efficacy" in interventional cardiology. The study examined the use of AI-driven Volta AF-Xplorer in addition to pulmonary vein isolation in treating patient with persistent atrial fibrillation.

For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.

Glucotrack is a step closer to marketing its implantable continuous blood glucose monitor, which met primary safety endpoints in its first human trial and is pitched as a potential alternative to existing CGM systems.

Oxford BioDynamics' blood-based colorectal cancer diagnostic test EpiSwitch NST has shown high accuracy (81-85%) and positive predictive values (57-87%) for colorectal cancer and polyps. By reducing false positives, the test could minimize unnecessary follow-up procedures.

BD plans to separate its biosciences and diagnostics division into a new business to enhance strategic focus and growth. The move, which has been approved by the board, is expected to go forward sometime in 2026.

While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.

Precision medicine startup LinusBio launches its breakthrough diagnostic aid across 44 US states. The laboratory test aims to support earlier diagnosis of autism spectrum disorder and can be ordered by health care providers.

Any tariff headwinds should be counterbalanced by currency tailwinds, predicts German imaging and diagnostics company Siemens Healthineers.

The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.

The US FDA says diabetes patients who rely on their smartphones to receive critical disease-related alerts should ensure their phones are configured correctly. If not, the alerts might be missed.

The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.