Evidence-based testing in real clinical settings and diagnostics tailored to community needs are crucial adoption success factors for new IVDs, Michael Wright, joint medical director at Newcastle...

Armor Medical’s wrist-worn wearable detected postpartum hemorrhage five times earlier than standard care in earlier studies. After surviving near-fatal hemorrhage herself, co-founder/CEO Kelsey Mayo...

Jupiter Endovascular is positioning Vertex as a next-generation pulmonary thrombectomy solution that could redefine procedural standards, especially if ongoing SPIRARE trials confirm its clinical...

Excitement surrounds Multi Cancer Early Detection testing for diagnosing hard-to-detect cancers early and improving patient outcomes. But without full randomized trials – only accuracy studies –...

J&J announced the separation of its orthopedics unit into a stand-alone company. The firm as a whole expects sales growth of over 5% in 2026. Gabelli analyst Jennie Tsai foresees more consolidation...

Europe’s medtech sector is actively supporting the European Commission’s push to cut red tape in environmental legislation. By offering practical solutions, the industry aims to ease regulatory...

The UK regulator adjusted its proposed 2026 device registration fee increase after criticism from industry, but now it has laid out how users should prepare for the uplift which is partly to pay for...

The recall of various Respironics sleep and respiratory care devices in 2021 plunged Philips into static growth and market share loss. Careful remediation is the group’s top priority, but S&RC head...

Spain is drafting a new digital health bill that aims to ensure the country is ready to implement the European Health Data Space Regulation.

Stakeholders have served up bold ideas - and familiar frustrations - in the EU’s latest MDR and IVDR consultation, giving the European Commission much to reflect on.

During a town hall session at AdvaMed’s MedTech Conference in San Diego, US FDA device center head Michelle Tarver discussed the center’s successes in product approvals, digital health, home health...

Family offices, impact funds, and public-private partnerships are among alternative approaches to financing that stress early-stage investment, collaboration, impact and health equity – but not, at...

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

In what seems to be the season of regulatory change in the UK, medtech stakeholders are checking their consultation diaries and gauging the value of the MHRA’s new AI Commission.

Ceribell has filed patent-infringement claims against Natus alleging its BrainWatch EEG copies Ceribell’s headband and electrode innovations. Natus denies any intellectual property violations, saying...

At the MedTech Conference, the CEOs of Stryker, Hologic and Insulet said during a panel AI is now central to their business strategies, from creating new medical devices to streamlining workflows and...

New notified body is listed under the EU Medical Device Regulation after no designations for a year.

The Santreva-ATK system integrates axial plaque traversal, lateral plaque compression and channel formation into a single mechanism, simplifying procedures that previously required sequential steps....

Successful implantations of a novel transcatheter mark a major step forward in treating congestion in heart failure, according to the California-based company that developed it. The procedure was...

Brazil’s government has implemented a three-pronged strategy to protect local industry, including medtech, from the worst effects of the 50% US tariff on Brazilian exports. But the option of counte...