Market Access

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

One year after the UK mooted the Rules-Based Pathway to give medtechs clarity on what can be expected from an evaluation, the devices industry says UK healthtech assessment and adoption processes are still failing to meet the needs of innovators and patients.

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

Boston Scientific has entered the multi-billion hypertension treatment market with the acquisition of Israel-based startup SoniVie, developer of the TIVUS intravascular ultrasound system for the treatment of high blood pressure by artery nerve ablation.

Only one year in the last decade involved more medtech acquisitions worth over $1bn than 2024, said McKinsey. A new report from the consulting firm found that despite an overall fall in activity for the life science sector, the economic and regulatory environment may support a strong rebound in dealmaking.

AvaSure’s new in-hospital virtual care assistant utilizes Oracle's cloud platform and NVIDIA AI software packages to improve clinical workflow by grading patients’ responses to a question format.

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.

Several counties in the US state of Georgia are maternity care “deserts.” Remote monitoring of high-risk pregnancies with maternal hypertension and diabetes could help improve the state’s high rate of maternal mortality, according to leading health service provider Philips.

Medtronic’s US FDA approval for BrainSense aDBS and BrainSense EI software features of the Percept neurostimulator device has quickly followed CE marking in January.

MELD Graph could help speed up the diagnosis and treatment of people with epilepsy by spotting "invisible" brain lesions often missed by radiologists. The new open-source AI tool developed by UK researchers could save the NHS up to $70,000 per patient, said researchers.

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.

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.