The U.K.'s Medicines and Health Care Products Regulatory Agency posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K.
The U.K. National Institute for Health and Care Excellence reported that mental health professionals experienced a dramatic increase in referrals for anxiety and depression over the past decade but noted that digital therapies might help manage the caseload, representing a significant opportunity for developers of these products.
Creo Medical Group plc entered into an agreement to sell a 51% stake in its European consumable business to Chinese medical device distributor, Micro-Tech Co. Ltd. for approximately €36.7 million (US$41 million) in cash on a cash free, debt free basis.
The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS).
The U.K. Medicines and Health Care Products Regulatory Agency enacted its AI Airlock program for artificial intelligence – the agency’s branding for its regulatory sandbox for this type of medical software.
There is no evidence to support the differences in prices that the U.K.’s national health service (NHS) is paying for transcatheter heart valves from Abbott Laboratories, Boston Scientific Corp., Edwards Lifesciences Corp. and Medtronic plc, according to the National Institute for Health and Care Excellence.
CSL Behring’s expensive hemophilia B gene therapy is to be reimbursed by the U.K. National Health Service, after the company agreed to an outcomes-based payment scheme. The therapy, Hemgenix (etranacogene dezaparvovec), which has a U.K. list price of £2.6 million (US$3.3 million), was approved under a managed access scheme, in which data will be collected over five years to enable both the long-term effectiveness, and any adverse liver toxicity caused by the transgene, to be monitored.
A new non-invasive device which enables women to test themselves at home for signs of the cancer-causing human papillomavirus strains in menstrual blood, has been developed with support from the Venture Builder Incubator at the University of Edinburgh.
Despite a couple of med-tech deals transacted this year and more liquidity in the market, early-stage medical device companies in Europe continue to struggle to raise funds. To attract interest from Venture Capital (VC) funds, these companies must ensure they have a disruptive technology, be willing to change their story, and do the math to ensure that VC firms who back them can get an adequate return, investors advised at the recent LSX World Congress in London.
The U.K. government said it is taking active steps to ensure that the country’s health and social care system can reliably access safe, effective and innovative technologies. One year following its inaugural medical technology strategy, the government reported changes underway which have already transformed the med-tech sector and consequently patients’ lives.
