Kent Imaging Inc. received CE marking for its SnapshotNIR imaging device which uses near-infrared spectroscopy to measure oxygenated and deoxygenated hemoglobin in the microvasculature. The non-invasive point-of-care device provides real-time data to clinicians to help them make decisions which can change the trajectory of a wound, from chronic and non-healing, into a healing one, significantly improving the patient’s quality of life.
Sonomind SAS raised €3 million (US$ 3.5 million) in financing for its transcranial neuromodulation system, which targets deep regions within the brain non-invasively. The funds will go towards accelerating the development of the platform, which has already proven to be safe and effective in treating patients suffering from drug-resistant depression, after only five days of treatment.
The lack of funding available for early-stage European med-tech and AI-based companies could soon see many go under as their current backers run out of capital, and new investors fail to materialize, Hubert Birner, managing partner at TVM Capital Life Science, told BioWorld.
Convatec Group plc secured CE mark and UKCA approvals for Convamatrix, its porcine placenta-based wound dressing designed for hard-to-heal wounds. The single use, skin substitute product is intended to cover, protect and provide a moist wound environment to support the body’s natural healing process.
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.
