Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.
Ireland’s life sciences and health tech companies raised a record-breaking €491.3 million ($572.9 million) in venture capital funding across 89 deals in 2024, according to a report from Enterprise Ireland. The investment underscores investor confidence in the country’s ecosystem, which looks set to continue despite global headwinds such as trade tariffs, economic uncertainty and rising operating costs.
Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture debt package of up to €37.5 million from the European Investment Bank and €10 million from existing shareholders.
SS Innovations International Inc. is experiencing rapid growth and rising demand for its SSi Mantra 3 surgical robotic system. Its revenues are increasing, and so are installations and procedures driven by the design features and affordability of the SSi Mantra, said Sudhir Srivastava, chairman of the board and CEO of SS Innovations. “The system that we have created is, in my personal opinion, better than anything that exists out there because of its various differentiating features and cost effectiveness,” he told BioWorld.
The European Investment Bank and Angelini Ventures have partnered to invest €150 million (US$174 million) in health care companies across Europe. The funding will target seven to 10 companies in biotech, med-tech and digital health in an effort to boost financing in the European health care ecosystem and support the development of innovative solutions across the continent.
The recommendation by a committee advising the U.K. government that screening for prostate cancer should not be made available to the vast majority of men could benefit companies such as Antegenes OÜ. The Estonia-based company develops polygenic risk score-based testing kits which help clarify an individual's genetic predisposition to specific cancers, providing a more targeted approach.
Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant economic benefits alongside improved clinical outcomes.
Mursla Bio Ltd. recently entered a partnership with an unnamed large pharmaceutical company to use its AI Precision Medicine platform to help with drug development and ultimately develop companion diagnostics. The collaboration uses Mursla’s platform ability to isolate and analyze extracellular vesicles from a simple blood sample, to provide biologically labelled, multiomics data to improve patient stratification, monitor treatment and develop companion diagnostics.
CMR Surgical Ltd. hopes to soon gain U.S. FDA 510(k) clearance for its Versius Plus surgical robotic system to bring it to the U.S. market amid rising demand for robotic surgery. Although the company’s original Versius system received FDA clearance in 2024 for use in cholecystectomy in adults, CMR waited to bring the enhanced Versius Plus model to market instead. “I have such a respect for the U.S. market that the last thing that I would do is to enter a market with a product that is outdated,” Massimiliano Colella, CMR CEO told BioWorld.
Overture Life SLU secured CE mark certification for its Davitri system that automates the vitrification and thawing of oocytes and embryos, making the processes more efficient, consistent and cost-efficient. Davitri has the potential to transform IVF, giving women and families more control over their fertility timelines and ensuring every egg and embryo has the best possible chance of survival.
