While European health care systems have historically lagged the U.S. in terms of digital adoption, a report by investment firm Albion VC is highlighting how the pandemic has created the momentum for change.

The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.

LONDON – Researchers in the U.K. have applied the heft of national population-level databases to devise a new algorithm that predicts those people who are most at risk of hospitalization and death from COVID-19, despite having received two doses of vaccine.

Merck KGaA has signed an agreement with French company Biocorp SA to develop a version of its Mallya smart device for monitoring human growth hormone (HGH) treatment. Mallya is a clip-on device for pen injectors that collects the dose and time of each injection and transfers the information in real time to a companion software using Bluetooth technology. The device is CE marked (Class IIb) and was first launched in France in 2020.

PARIS – Sofinnova Partners SAS reported the successful closing of its med-tech accelerator fund, Sofinnova MD Start III, at $75 million. The fund had been oversubscribed and exceeded its original quota, with new investors joining existing ones such as Medtronic plc, Liva Nova plc, Baxter International Inc., French national public investment bank Bpifrance and the European Investment Fund.

The new regulatory framework for the EU is now in force, and it touches on the respective roles of manufacturers, distributors and other economic operators (EOs). Erik Vollebregt, of Axon Lawyers in Amsterdam, told an audience at the 2021 Regulatory Convergence sessions that the roles and responsibilities of these EOs are frequently misunderstood, a predicament that amplifies the regulatory and legal risk for all these entities doing business in the EU.

Three is the magic number for Finnish companies Abacus Diagnostica Oy, Kaivogen Oy and Labrox Oy as they link up to develop a new diagnostic solution combining antibody and PCR testing on a single device. The three Turku, Finland-based companies said they are joining forces to form a new diagnostics powerhouse, harnessing their own unique expertise. Abacus Diagnostica develops molecular testing and rapid PCR tests while Kaivogen specializes in immunoassays and antibody tests and Labrox on laboratory instruments. All companies have previously collaborated on R&D projects.

PARIS – Researchers at the Institute for Surface Technologies and Photonics in Weiz, Austria, and the Institute of Scientific and Industrial Research Osaka University, Japan, have invented new ultra-flexible health monitoring patches that use harvested bio-mechanical energy. “These new devices represent a wireless e-health patch for accurate pulse and blood pressure monitoring,” Andreas Petritz, from the Institute for Surface Technologies and Photonics (the materials research unit of Joanneum Research FmbH), told BioWorld.

LONDON – Health data specialist Sensyne Health plc is opening up broader access to its U.S./U.K. patient information system with the launch of a subscription service giving accredited users the ability to interrogate more than 2 million longitudinal electronic health records. At an annual cost of £25,000 (US$34,602) per head, the company will provide “industrial scale” access to anonymized hospital records “to the smallest company or to a single researcher working in academe,” through the new Sensight service, said Paul Drayson, CEO.

LONDON – Oxford Biodynamics plc won a $910,000 grant to help validate real-world use of its epigenetics test for identifying patients who will respond to treatment with checkpoint inhibitor drugs. The award was made as part of the Beau Biden Cancer Moonshot.