FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
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The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Execs On The Move: July 14–18, 2025

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

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.


Medtech M&A Resurges: How To Define Startup Exit Strategy

 

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

Intuitive Surgical Sees Early Wins With Da Vinci 5, Lifts FY25 Guidance As Tariff Impact Eases

 
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For the full year, the company now expects tariffs to increase the cost of sales by approximately 1% of revenue, plus or minus 20 basis points. This is lower than the previous estimate of approximately 1.7% of revenue. The updated gross margin guidance for 2025 is 66%-67%, up from 65%-66.5%.

ForSight Sets Its Sights On Automating Delicate Eye Procedures

 
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ForSight Robotics is developing a robotic platform to automate cataract and other eye surgeries, aiming to ease surgeon strain and expand access. Backed by $200m in total funding, it's targeting a first human surgery using Oryom by year-end and is in discussions with US FDA.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
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The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.


Injuries And Deaths Linked To Baxter Infusion Pump

 

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Bates To Energize UK Office For Life Sciences

 
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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.

Private Equity Firm Archimed To Buy ZimVie As Antitrust Concerns Sideline Strategic Buyers

 
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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.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
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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.


Opinion: Catch A Fraudulent Scientist -- If You Can

 
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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.

Medtronic’s MiniMed Expands EU Uses Of MiniMed 780G And Readies For US Expansion Amid Competition

 
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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.

Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

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.

Rising Oncology Start-ups Recognized For Breakthrough Cancer Research

 

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.


HeartFlow Takes Another Crack At Public Markets With $100M IPO Filing

 
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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.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
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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.

Abbott Lowers Outlook But Headwinds Are Temporary

 

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.

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
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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.