Milleporesigma, Merck KGaA’s North American life sciences business, agreed to acquire Mirus Bio LLC from Gamma Biosciences LP for $600 million. Mirus develops tailored transfection solutions that deliver nucleic acid into cells used in production of viral vector-based gene therapies. It also provides contract development and manufacturing services. The transaction is expected to close in the third quarter of 2024, subject to U.S. regulatory approvals and customary closing conditions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiodynamics, Indica Labs, Virtual-Ports.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aim Medical Robotics, Biocardia, Bio-techne, CDL Laboratories, Lunit, Synaptive Medical, Molecular Instruments, Nanostics, Nanovibronix, Roche, T2 Biosystems, Volpara Health.
Abbott Laboratories announced a class I recall of the Heartmate 3 left ventricular assist system (LVAS) that affects nearly 890 units distributed over the past three years, a move triggered by reports of blood leakage or air entry into the device during implant procedures.
The European Council (EC) voted to approve the Artificial Intelligence Act (AI Act), a sweeping horizontal legislative product that affects all sectors of the European Union’s (EU) economy. Regulatory attorney Erik Vollebregt told BioWorld that the horizontal nature of the AI Act is still likely to exacerbate some of the problems already seen with the Medical Device Regulation (MDR) in a way that he said will make the EU market less attractive than is already the case.
Nuvo Group Ltd. recently completed a business combination with Los Angeles Media Fund (LAMF) Global Ventures Corp, a special purpose acquisition company, and became a listed company in a bid to bring its Invu pregnancy monitoring and management platform to as many women as possible. “We are totally focused on women's health and trying to drive better outcomes through pregnancy care,” Rice Powell, CEO of Nuvo, told BioWorld.
News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.
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