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.

PARIS – In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product.

LONDON – With COVID-19 infection varying in severity from asymptomatic to lethal the search is now underway for biomarkers to predict which patients are most at risk of suffering severe disease. As one possibility, Menarini Silicon Biosystems (MSB) is using its Cellsearch liquid biopsy technology to capture and count circulating endothelial cells. Meanwhile, Oxford Biodynamics plc is applying its Episwitch platform to find prognostic and predictive epigenetic markers.

PARIS – April 2020 was a milestone month for the key players in interventional cardiology in France. The reimbursement system in France is finally opening its doors to the drug-eluting balloon (DEB), following years in the wilderness.

Artificial intelligence-focused Chronolife SAS, of Paris, has secured class IIa medical certification from the EU for its smart T-shirt, which has the new brand name Keesense. The reusable, washable T-shirt is designed for comfortable, round-the-clock use. It works by transmitting data to a paired smartphone app via Bluetooth.

DUBLIN – Kurma Partners closed its third biotech fund, Kurma Biofund III, at €160 million (US$174 million), €10 million ahead of its initial target. The Paris-based fund will allocate the bulk of the capital to therapeutics firms, but it is also open to opportunistic investments in med tech, particularly in digital health applications and in biotech-med tech convergence, partner Peter Neubeck told BioWorld.

LONDON – Noscendo GmbH closed a series A round to finance the commercialization of its next generation DNA sequencing test for the fast diagnosis of bloodstream infections. At the same time, the company reported the start of operations at a new testing lab.

PARIS – Braintale SAS, of Paris, has gained CE mark approval for Brainquant. This software platform, which uses DICOM radiology imaging, enables diffusion MRI scans to be processed as part of managing patients in a coma following brain injury.

Siemens Healthineers AG expects to have a total antibody test available in late May 2020 to identify individuals exposed to the SARS-CoV-2 virus that causes COVID-19. The rapid diagnostic test detects IgM as well as IgG and other antibodies in the blood.

LONDON – The European Parliament gave its full backing to the emergency measure to delay the Medical Device Regulation (MDR), voting by 693 to 1 in favor of postponing implementation from May 26 this year, to May 26, 2021. The delay will “allow health authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic” by keeping existing procedures in place, the parliament said in a statement.