Medtech Insight
Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.
Archimed will acquire dental implant firm ZimVie for $730m in a deal that reflects private equity’s growing role in medtech M&A, as strategic buyers face antitrust scrutiny. The deal includes a 125% premium and a 40-day window for competing offers.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
As AI tools make research fraud and résumé fraud easier than ever, life sciences companies need to take steps to protect themselves. Snedden Campbell CEO Ivor Campbell has some tips on successful strategies.
The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.
The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.
The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.
AI heart imaging company HeartFlow filed for a $100m IPO after scrapping its 2022 SPAC plans. It remains unprofitable but is betting on FDA clearances, Medicare coverage and a demand for AI-powered diagnostics to win over investors.
A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.
Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.
An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
Worldwide medtech sales totaled $8.5bn in Q2, up 6.1%. Sales grew 8% in the US and 4.1% outside the US. Cardiovascular, surgery and vision were the primary growth drivers. Acquisitions and divestitures had net positive impact of 200 basis points, largely due to the acquisition of Shockwave Medical.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
In this week's Digital Health Roundup, Medtech Insight's team discusses progress on autonomous surgery, Medtronic's new partnership with IRCAD, FDA cybersecurity news, and C-suite interviews with OpenWater, Flow Neuroscience and EnsoData.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.