The European Commission has proposed legislation that would ease some of the EU’s barriers to innovation, but MedTech Europe said that while the European Innovation Act would be helpful, it is no substitute for fixing what’s already ailing the EU med-tech industry.

Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.

Edap TMS SA signed a €36 million (US$42 million) multi-tranche credit facility with the European Investment Bank, with the first tranche of €11 million expected to be disbursed in early November. The funds will be used to strengthen the company’s balance sheet to support the continued expansion of its Focal One high-intensity focused ultrasound technology in focal therapy and accelerate the development of new clinical indications.

Comind Technologies Ltd. secured $60 million in funding for its optical neuromonitoring device which non-invasively measures key physiological parameters of the brain to provide critical information on its health. The technology could significantly improve the way the brain is monitored by addressing key challenges of current methods such as inaccuracy, invasiveness and limited availability when needed.

The U.K. Competition and Markets Authority (CMA) has issued draft guidelines for remedies for mergers and acquisitions, which the agency insists incorporates some regulatory flexibility. However, CMA said its approach is premised on the notion that any regulated transaction should have zero effect on competition in the affected industry, a premise that would seem to quash any transaction that leads to fewer companies in that industry.

The U.K. Medicines and Healthcare Products Regulatory Agency reported the winners of the second phase of the AI Airlock challenge, which includes the Tortus AI, a medical scribe system developed by physicians in the U.K. National Health Service.

Private equity firm Keensight Capital acquired a majority stake in Bedfont Scientific Ltd. in a move that will allow the company to expand the use of its devices for breath analysis and monitoring worldwide. Although the value of the deal was undisclosed, Keensight typically invests in profitable companies generating revenues in the range of €10 million to €400 million.

Oura Health Oy raised more than $900 million in a series E funding round to fuel global expansion of its popular smart ring and development of new health technologies. The new infusion brings the company’s total funds raised to date to $1.5 billion and implies a corporate valuation of about $11 billion, Oura said.

Who knew? In addition to adopting a new name, Kneu Health Ltd. recently raised $5.6 million in a seed funding round for its smart-phone-based platform which helps to monitor neurological disorders to enable timely intervention. The funds secured will be used to expand commercial operations in the U.S., scale deployments for Parkinson's disease and advance the monitoring capabilities of the platform for dementia.

Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.