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.
Carmat SA recently reported a software update for its bioprosthetic total artificial heart Aeson device that will significantly improve its safety profile. In the past, the company had to suspend implantations of its device following issues around quality. With the enhancements, the Aeson software will be able to detect signals of malfunctions in real time and adapt the control of the prosthesis so that its performance is not affected.
To say that 2023 continued to be a difficult fundraising environment for companies in Europe is an understatement. However, there were some green shoots and investors continued to back companies, seeing opportunities across the health tech, med-tech and biotech space.
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.
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