Med-tech deals are showing a 136% increase in value, partially due to rising interest in digital health technologies, and despite decreasing activity focused on the COVID-19 pandemic. While deal values are up, the opposite is true for M&A values. They have fallen by 15% in comparison with the same time frame last year.

The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.

Engineers at Atlanta-based Georgia Tech’s Center for 3D Medical Fabrication have developed a 3D-printed tracheal splint as an airway for children born with a rare condition known as tracheal agenesis or the absence of a trachea or windpipe.

U.K. startup Tympahealth Technologies Ltd. has received $8 million in seed financing for commercialization of its point-of-care hearing health assessment system. The Tympa system is a CE marked and FDA-registered device for high-resolution ear drum visualization, ear wax removal and hearing screening assessments. Health care entrepreneurs Maurice Ferre and Arjun Desai led the financing round.

Mindmaze SA continued to add significant funds to its coffers with $105 million as part of a series B financing round, following a $125 million debt financing in October. The new money brings total funding to more than $300 million for the company’s virtual reality-based digital neurotherapeutics platform. Its successful fundraising has pushed the company into unicorn status, making it the first Swiss firm to be valued at more than $1 billion.