Thales SA signed a major partnership with the Curie Institute to use very high-intensity electron FLASH radiotherapy (FLASH-RT) in cancer therapy. Based on its experience in the field of particle accelerators, “we have all the manufacturing facilities and human know-how necessary to ramp research and development for this new technology,” Charles-Antoine Goffin, vice president, microwave & imaging subsystems at Thales, told BioWorld. 

Illumina Inc.’s acquisition of Grail Inc., of Menlo Park, Calif., may or may not prove to be a case of jumping the regulatory gun, but the move to date has not racked up significant financial penalties for the company. That may soon change per a statement by the European Commission, which said that Illumina may find itself on the receiving end of “hefty fines,” a statement made by EC executive vice president Margrethe Vestager.

In an era of ever-increasing change in regulation of medical devices, the 2021 draft regulatory proposal by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) might have seemed like an invitation to regulatory balkanization. However, MHRA said the responses to the draft proposal indicated widespread support for “international collaboration with like-minded regulators,” thus reassuring industry that their developmental devices won’t face an entirely new set of barriers to access to a market of more than 67 million.

The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.

Ibex Medical Analytics Ltd. extended the reach of its artificial intelligence (AI) powered pathology system, adding gastric cancer to existing CE mark approvals in prostate and breast cancer.

The EU’s Medical Device Coordination Group (MDCG) has advised the device industry that many manufacturers seem ill prepared for the transition to the Medical Device Regulation (MDR), which will be fully in force for all devices as of May 2024. MDCG said that that any leniency shown after that date will be granted only for devices that address an urgent public health need, potentially leaving many existing authorizations out in the cold.

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.