Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

Two Chairs, which uses algorithms to match the right therapists with patients, secured $72m in investment to expand its business.

J&J’s acquisition of IVL device maker Shockwave Medical for $13.1bn sets J&J’s medtech arm solidly in a leadership position in multiple cardiovascular markets.

Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.

Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.

Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.

Delays have plagued J&J's soft tissue surgical robot. However, the company has now solidified at least its near-term plan and hopes to commence trials later this year.

Views from medtech industry leaders and investors on the most significant uncertainties and opportunities facing the sector in 2024. 

At a webinar organized by the Association of the European Self-Care Industry, sustainability expert Onur Durmus, partner at ERM, gave an overview of the Corporate Sustainability Reporting Directive and what consumer health companies must do to ensure compliance.

Ankur Dhingra has replaced Joydeep Goswami as Illumina’s chief financial officer after Goswami spent just 14 months on the job. The San Diego-based sequencing and array tech company also appointed Jakob Wedel as chief of strategy and corporate development officer.

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

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

Medtech Insight's News We're Watching highlights medtech industry developments we are following: LivaNova named a new CEO, Roche confirmed plans to launch a continuous glucose monitor, Virtual Incision sent its surgical robot into orbit, and Synchron announced a deal with Acquandas to advance its brain interface technology.