Mittelstand Santé, a new Franco-German health-tech alliance, has just published its first compilation of feedback from executives of French and German health care companies relating to the COVID pandemic. The French contingent is developing proposals aimed at strengthening the resilience of European health care manufacturing.

Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.

Penumbra Inc. presented new data at the LINC Symposium in Leipzig, Germany, evaluating its Indigo aspiration system for submassive pulmonary embolism (PE). The subgroup analysis evaluated performance outcomes of patients with main pulmonary artery (PA) emboli vs. discrete unilateral or bilateral PA emboli without main PA involvement. Data from the study suggests the system can be used effectively for both proximal and distal aspiration thrombectomy in the pulmonary arteries.

Grail LLC reported a new study with the U.K.’s NHS to assess the clinical utility of its Galleri multi-cancer early detection test (MCED) for reducing late-stage cancer diagnoses. Menlo Park, Calif.-headquartered Grail presented the study design during the American Society of Clinical Oncology (ASCO) meeting in Chicago. The randomized controlled trial will enroll 140,000 asymptomatic participants aged 50-77 living across England to determine if Galleri can find cancers at an early stage when they are less advanced.

Two studies published back to back in Nature have looked at the accumulation of mutations in blood-forming stem cells with age, gaining new insights into how the overall landscape of such cells changes across the lifespan. 

Healiva SA, a Swiss wound care specialist, emerged from stealth mode having acquired two cell therapy assets from Smith & Nephew plc. Financial terms were not disclosed, but they included an up-front payment as well as “deferred benefits,” Healiva CEO and founder Priyanka Dutta-Passecker told BioWorld. The deal means that the Lugano-based company – which was formed in 2020 – could be booking revenues as early as 2023.

Vitestro BV is preparing for pivotal clinical studies of its automated phlebotomy device after unveiling the prototype to clinicians in the Netherlands.

Less than three years after unveiling the first Sonovein device, Theraclion SA is launching its CE-marked, third-generation platform, Sonovein HD. This represents a new generation of robotics platform for noninvasive treatment of varicose veins. The new version integrates the acquisition and analysis of technical data during the procedure.

Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.

“The incomplete in vitro diagnostic regulation (IVDR) poses critical ongoing risks that need urgent resolution,” said Medtech Europe, as it welcomed the coming into force of the new EU regulatory system on May 26. Five years since the publication of the regulation, and after the industry has invested “significant resources into complying with its requirement,” some key elements of the infrastructure “are still not fully operational or even in place,” according to the trade body. “It is critical that all needed infrastructure is put in place and made operational without delay,” said Serge Bernasconi, CEO of Medtech Europe.