PARIS – Fineheart SA, of Bordeaux, France, reported the success of a seven-day preclinical study to evaluate its Implantable Cardiac Output Management System (ICOMS), the first fully Intra-Ventricular Flow Accelerator synchronized to the native heartbeat to restore natural heart pumping capacity.

Like many other med-tech companies, Medtronic plc, of Dublin, saw COVID-19 affect its financial results for its fourth quarter and fiscal year 2020, as procedures were deferred in the wake of the pandemic. Quarterly worldwide revenue came in at $5.998 billion, representing a decrease of 26% as reported and 25% on an organic basis.

Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.

PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as U.S. FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld.

LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.

LONDON – The U.K. is launching a £28 million (US$34.5 million) project to sequence the whole genome of every COVID-19 patient in the country treated in intensive care, with the aim of uncovering host genetic factors that lead some people to be more severely affected by the infection. The study will involve up to 20,000 people currently or previously treated in one of 170 intensive care units (ICUs), whose genomes will be compared to 15,000 people with a confirmed infection who had mild or moderate symptoms.

DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million.

LONDON – A new technique for analyzing solid tumor DNA has been shown to significantly improve scoring of mutation burden, making it possible to identify patients who will respond to immunotherapy.

The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.

Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO₂) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.