Oncology

The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.

Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.

The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.

Careology and Entia are partnering to “alleviate the burden of routine patient assessments” on people with cancer. The two early-stage London-based health tech startups already provide services to UK National Health Service (NHS) patients.

Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.

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.

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The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases.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

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.

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.

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.

Applications for the AI Airlock regulatory sandbox pilot phase closed in October. The selected technologies address hospital administrative load, earlier treatment intervention and real-time AI monitoring.

Exact Sciences lowered its full-year 2024 midpoint guidance by $90m. Commercial adjustments to the sales force are being made "to fix the basics," senior company executives told the Jefferies London Healthcare Conference.

Guardant Health expects to break even by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.

This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

Massachusetts-based Harbinger Health has partnered with Memorial Sloan Kettering Cancer Center in New York to accelerate the validation of its AI-driven blood test for early-stage cancer detection. The company also recently presented encouraging data at two conferences.