Organox Ltd.’s normothermic machine perfusion device, Metra, has been cleared by the U.S. FDA for use during air transport. The greenlight from the regulatory body paves the way for the broader use of donor organs that might otherwise be discarded, as the Metra system circulates oxygen and nutrient rich perfusate through the organ at near-body temperature, extending preservation times.
An international team of researchers has successfully used Onward Medical N.V.’s ARC-IM therapy to develop a neurostimulation system that improves blood pressure stability in patients with spinal cord injuries. According to data from two studies published in Nature and Nature Medicine, the implanted system also led to durable reduction of hypotensive symptoms, resulting in an improvement in the quality of life of patients.
Roche Holdings AG received CE mark approval for the integration of its AI-enabled continuous glucose monitoring system, Accu-Chek Smartguide, with the Mysugr diabetes management app. The integrated solution, which combines predictive CGM technology with therapy data in one place, will simplify the daily decision-making for users managing their diabetes.
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
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.
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.
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.
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.
