Uncertainties brought on by tariffs have certainly dampened the optimism in the med tech sector seen at the beginning of the year, as it has slowed M&A and fundraising activity. However, companies developing differentiated products based on solid technology, supported by substantial clinical data, will attract financing and M&A activity will return, Luc Marengère, managing partner at TVM Capital Life Science, told BioWorld.

The first phase of the EU’s Data Act is now officially in place, although member state enforcement of the Act might be spotty. This is because several nations, including Germany, have yet to finalize implementing regulations for the Data Act, a problem these nations will have to fix as the secondary and tertiary compliance dates arrive in August 2026 and August 2027.

Two months after it was launched, the wheels are coming off the U.K. government’s 10-year life sciences strategy, with pharma companies withholding promised capital investments in protest at the row over drug pricing. Merck & Co. Inc., Astrazeneca plc and Eli Lilly and Co. Inc. have said they are not going ahead with previously announced investments.

Tensive Srl's Regenera, a bio-absorbable breast implant, promises to help the millions of women who undergo breast cancer surgery every year, to feel whole again. “While surgery will save many lives, it comes at the cost of losing something very personal, which is the sense of a woman's wholeness. I think that's what has been a major challenge,” Sanjay Kakkar, CEO told BioWorld.

Remynd NV has turned in positive phase IIa data for a new target in Alzheimer’s disease, showing that restoring calcium homeostasis in neurons reduces levels of pathological tau proteins, increases dopamine levels and has a positive effect on cognition in symptomatic patients.

In a real-world study, Eko Health Inc.’s AI-enabled digital stethoscope dramatically increased detection rates for atrial fibrillation, heart failure and valvular heart disease in primary care settings. Researchers from Imperial College London presented results from the study at the European Society of Cardiology in Madrid.

Regulatory and reimbursement challenges in Europe are leading an ever-increasing number of med tech companies to prioritize the U.S. market for the launch of their devices. However, certain technologies can reach European patients more quickly, presenting valuable opportunities with the EU, delegates heard at the LSI Europe ’25 conference in London this week.

Safeheal SAS secured a further €10 million (US$11.72 million) in a series C extension funding round, adding to the €35 million it raised earlier in the year. The funds will go towards Colovac, its temporary endoluminal bypass device designed as an alternative to stoma for colorectal cancer patients undergoing surgery.

The financing environment remains difficult for solutions addressing women’s health, Lara Zibners, co-founder and chair of Calla Lily Clinical Care Ltd., told BioWorld. “Until I entered this space, I've never spoken to an investor in any other area who said, ‘I need to go home and ask my wife’,” she said on the sidelines of the LSI conference in London.

The European Commission (EC) posted a call for evidence regarding its intent to “simplify EU rules” for medical technology with a comment period that began Sept. 8, 2025. Stakeholders almost immediately flooded the docket with recommendations.