Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder.
Dxcover Ltd. initiated three pivotal trials to measure the efficacy of its liquid biopsy platform for early detection of brain, colorectal and lung cancers. The company hopes the trials will provide the evidence needed to gain regulatory approval and begin commercial operations of its diagnostic technology in Europe and the U.S.
The EMA has once again come in behind the U.S. FDA, granting market access to 77 new products in 2023, fewer than half the 157 approvals the FDA processed in the 11 months from January through December 2023.
Onera Technologies BV raised €30 million (US$32.7 million) in a series C funding round that will allow the company to accelerate the manufacturing and deployment of its patch-based sleep test system. The funds will also go towards concluding the development of the company’s second-generation polysomnography (PSG) system.
Six weeks after the U.S. FDA issued an alert, the EMA is following suit and starting a review of the safety of six approved CAR T-cell cancer therapies, following 23 reports of patients developing secondary cancers. The EMA said such malignancies were considered “an important potential risk” at the time of approval and are included in the risk management plan. Close monitoring is in place, with companies required to conduct long-term safety and efficacy follow-up studies and to file safety update reports.
The U.K. Medicines and Healthcare Products Regulatory Agency finalized its plans for an overhaul of its med-tech regulatory system in a comprehensive approach that captures both in vitro diagnostics and artificial intelligence.
Medtronic plc received CE mark for its latest miniature, leadless pacemakers, the Micra AV2 and Micra VR2. According to the company, they are the world's smallest pacemakers, provide a longer battery life, and are easier to program than previous Micra pacemakers, while maintaining the benefits of their predecessors such as reduced complications compared to traditional pacemakers.
Switzerland’s regulatory authority for devices and drugs, Swissmedic, decided to revamp how it organizes its postmarket surveillance work, and is also seeking to stand up its medical product surveillance database.
Roche Holding AG entered into a definitive agreement to buy Lumiradx Ltd.’s point-of-care technology platform for $350 million. The deal is part of Roche’s effort to transform its point-of-care portfolio and enable more patient-centric health care. For Lumiradx, the sale is the end of a journey to restructure and refocus the company and will result in it being delisted from Nasdaq.
After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.
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