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.

Companies developing AI-based health care solutions need to ensure they have quality data, a solution that can easily integrate into clinical workflow systems and teams with evolving skills, to attract investment, delegates heard at the LSI Europe ’25 conference in London.

IMU Biosciences Ltd. is working to transform society’s understanding of the immune system. The company’s platform maps the immune system at molecular, cellular and system levels, to unlock new insights into immune-related health and diseases, paving the way for clinical applications that could improve patient outcomes.

Quantum Surgical SAS has secured CE marking for the expanded use of its Epione robotic platform to treat bone tumors and metastases. The regulatory green light allows surgeons to use Epione to treat inoperable tumors which are difficult to reach due to their size or location at an early stage, in a simple and effective way.

Vicentra BV’s insulin patch pump, Kaleido, will soon reach more patients with diabetes after it raised $85 million in a series D funding round. The company said the Kaleido is among the smallest, lightest, and most precise insulin patch pumps available.

The Danish-German Cardiogenic Shock trial found that men implanted with Johnson & Johnson’s Impella CP after experiencing a heart attack with cardiogenic shock gain 600 days of life, on average, compared to usual care at 10 years. The study demonstrated no benefit for women.

Cyted Health Ltd. raised $44 million in a series B financing round to expand the reach of Endosign, its capsule sponge technology, in the U.S. Endosign is a minimally invasive device used to collect cell samples from the esophagus for the early detection of esophageal diseases, offering the potential to transform early cancer detection and improve health outcomes.

The U.K. Medicines and Healthcare Products Regulatory Agency announced a new pilot program for modifications to clinical trials that allows for automatic approvals of those changes based on the risks those changes present.