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.
As their term in office winds to a close, MEPs in the two main political groupings of the European Parliament still have huge differences of opinion over the proposed reform of the EU pharmaceutical regulation and how best to achieve the stated aims of improving patient access whilst encouraging innovation.
Over the past few years, the health care sector has been progressively leveraging artificial intelligence techniques for activities such as end-to-end drug discovery and development, diagnosing patients, improving communication and engagement between physician and participant, transcribing medical documents and remotely treating and monitoring patients.
Pharma companies facing the pricing pressures unleashed by the U.S. Inflation Reduction Act will find little respite in European markets in 2024, as governments erect higher market access hurdles around pricing and reimbursement in a bid to constrain drug budgets.
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