Diagnostics

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.

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.

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.

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.

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The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases.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.

Stock prices for liquid biopsy firm Angle Plc are up since 28 January after the release of new research. The study used Angle’s technology to detect clinically relevant mutations in circulating tumor cells that were not found in traditional circulating DNA, allowing for further insights into cancer progression, Andrew Newland, Angle CEO, told Medtech Insight.

Seven new Centers of Excellence for Regulatory Science and Innovation have been funded by the UK with a brief to investigate smart regulation of AI and digital health innovations, among other areas. Medtech Insight asked Alastair Denniston, leader of the CERSI in AI and Digital Health Technologies, to explain the significance and the goals of his center.

Avandra CEO says the company has created the world’s largest federated network for de-identified imaging data, providing researchers access to medical images that will accelerate the advancement of clinical trials, precision medicine and AI applications.

During CES 2025, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis to identify the biggest trends in digital health and solutions poised to transform the future of health care. Key trends included empowering consumers with actionable health data, the rising investment in specialized areas such as women’s health, and more companies pursuing regulatory clearance for health products.

Quibim announces $50m in an oversubscribed series A funding round. Quibim CEO Ángel Alberich-Bayarri discusses his plans for the new financing and the company’s competitive edge in training AI with multimodal data.

Sara Brenner, a preventive medicine and public health physician at the US FDA who served in the first Trump administration, has been named the agency’s acting commissioner.

What's coming in 2025? Commissioner Makary, more digital health, and no movement on LDT regulation, predicts consultant and former FDAer Steve Silverman. See his reflections on the year ahead, as well as what he got right -- and wrong -- for 2024, here.

Guardant Health seeks to bring genomic cancer disease data into a clinical context in a new collaboration with ConcertAI aimed at designing cancer therapeutics and clinical trials, Amar Das, VP of real world evidence at Guardant Health, told Medtech Insight.

Inflammatix received US FDA clearance to market its TriVerity Test System to help emergency departments quickly triage patients suspected of having acute infection or sepsis. Medtech Insight spoke with Inflammatix CEO Tim Sweeney about the company’s business strategy and marketing plans.

Boston-area start-up Axoft is developing a soft brain-computer interface device to help coma patients with covert consciousness communicate. Medtech Insight spoke with Axoft’s CEO Paul Le Floch about the technology, plans for first-in-human trials and potential future applications of the device to help patients with disorders of consciousness, including patients in a coma or vegetative state, communicate.

In this second roundup of innovative technologies seen or demoed at CES 2025, Medtech Insight tunes into heartbeat-listening earbuds, vision aids for people with macular degeneration, UTI-detecting toilets, non-invasive injection devices, hot flash-cooling wristband, mobility-aiding smart shoes, and robotic aids for cerebral palsy.