Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
U.K. scientists developed a saliva-based test which better predicts the risk of prostate cancer than current prostate-specific antigen (PSA) blood tests by analyzing DNA to look for genetic variants linked to prostate cancer and calculating a polygenic risk score.
Medicud Srl received over €1.3 million (US$1.4 million) in seed funding to support clinical trials and secure regulatory approval of Dryum, its incisional negative pressure wound therapy system.
Med tech and diagnostic companies in Europe are considering strategies to navigate the U.S. market following President Trump’s introduction of reciprocal tariffs on imports. While some companies are more exposed than others, there’s no doubt that many will feel the pain.
Pulsed field ablation using Boston Scientific Corp.’s Farapulse system was non-inferior and even superior, slightly, to Medtronic plc’s Artic Front Advance cardiac cryoablation system in treating patients with paroxysmal atrial fibrillation.
French venture capital firm Karista led a series B extension financing round for Samantree Medical SA to take the total raised in the round to $20 million. The funds will be used to launch Samantree’s Histolog scanner in the U.S. market.
Calla Lily Clinical Care Ltd. secured £1 million (US$1.3 million) in funding from the National Institute for Health and Care Research to begin clinical trials of Callavid, a drug delivery technology which treats women at risk of miscarriage.
CMR Surgical Ltd. secured more than $200 million in funding to bring its surgical robotic system, Versius, to the U.S. market and expand elsewhere. The financing, which came in the form of equity and debt, is “highly important” for the company and comes at the right time as it is “expanding and growing nicely,” company CEO Massimiliano Colella told BioWorld.
Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.
The use of an AI tool could speed up the time it takes to do pregnancy scans by almost half and it is still able to identify any abnormalities in the fetus, researchers found. Results from a study showed the AI tool used to assist with 20-week pregnancy scans reduced the scan length by more than 40% and still maintained the same accuracy and reliability of diagnoses.
