The US FDA’s new initiative to create an idea lab for medical device use at home will benefit device manufacturers, patients and policymakers alike.
Home use is often an afterthought in medical device development, and many devices need to be retrofitted for the home. The new Home as a Health Care Hub initiative from the Center for Devices and Radiological Health at the US Food and Drug Administration is helping to rethink that model.
CDRH announced the $1.2m initiative on 23 April. Michelle Tarver, deputy director for transformation at CDRH, told Medtech Insight...
Medtronic’s diabetes spin-out – a process likely to run up to 18 months and involve 20% IPO followed by a split-off for Medtronic shareholders – will allow firm to focus on higher-margin devices.
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
Roche’s Indianapolis site currently produces 5.2 billion Accu-Chek test strips annually and supports distribution to 53 countries. The new CGM line will add to an already diversified operational footprint, which includes R&D, laboratories, manufacturing, and IT services.
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
