Leadership

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.

Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

Wearable technology must address women’s unique needs, said Anja Streicher, Women of Wearables chief marketing officer. Samphire Neuroscience and Amira Health demo wearable solutions for PMS and hot flashes at Wired Health.

Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.

President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.

The US FDA is seeing more staff turnover this week, with CDRH deputy director for science Douglas Kelly announcing his departure while the agency gets a new chief counsel and chief of staff.

The FDA commissioner nominee offered few details on device policy, but said he was open to funding device postmarket surveillance through user fees. He also offered some defense of staff cuts while saying he would perform his own assessment before planning any more.

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.

In this first of a two-part series highlighting digital and healthtech innovation in Barcelona, Medtech Insight visits the Barcelona Health Hub, a nonprofit that seeks to advance digital health innovation by bringing together start-ups, investors, health care institutions and corporations.

10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.

Most fired staffers in the FDA’s device center are now back at work, according to several who were unceremoniously let go over the President’s Day weekend purge.

Some US FDA employees who were recently laid off by the Trump Administration, including in CDRH, are being called back to work, multiple sources confirmed to MTI's sister publication, the Pink Sheet.

Foster, an advisor to the HHS Assistant Secretary for Preparedness and Response during the COVID-19 pandemic and counsel to the Senate HELP Committee, also served in various legal roles at small biotech companies. He replaces agency veteran Mark Raza.

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.

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.

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

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.