Alcon AG plans to acquire Lumithera Inc., adding its photobiomodulation (PBM) device designed to treat early and intermediate dry age-related macular degeneration (AMD) to the Alcon portfolio. The financial terms of the deal were not disclosed. The move continues Alcon’s strategic expansion in eye care, following on its recent acquisitions of Aurion Biotech Inc. and Lensar Inc. Read More

The next FDA device user fee agreement is formally in negotiations but a recent agency report shows device makers are increasingly keen to interact with FDA reviewers. This is a fact that may make it difficult to keep the next user fee schedule from increasing dramatically over the current agreement. Read More

With the June 9 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee party-line vote of 12-11, Susan Monarez’s nomination is headed to the Senate floor where she could become the first CDC director to go through the confirmation process. That’s thanks to a provision in the bipartisan PREVENT Pandemics Act that was signed into law in 2022. Read More

The U.S. FDA noted in a series of Federal Register declarations that several device makers are working with the Patent and Trademark Office to claim regulatory review times for their devices, including the Sapien 3 Ultra Resilia device by Edwards Lifesciences Corp. Read More

Researchers from IMEC, the Netherlands’ OnePlanet Research Center in Wageningen, filed for protection of an inexpensive, highly miniaturized ingestible device that may be used for remotely activatable sampling, gut health monitoring and drug delivery. Read More

New hires and promotions in the med-tech industry, including: Mercy Bioanalytics, Merit Medical, QT Imaging, Tellihealth, Vialase. Read More

Med-tech firms raising money in public or private financings, including: Actithera, Neuros, Plexāā. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ultromics. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Caretaker Medical, Circular Genomics, Duke Empirical, Exact Sciences, Fluidai, Fujirebio, H.U. Group, Kinova, Mediview, Quest, Real-Time Innovations, Rockwell, Team Technologies, Terumo. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aktiia, Boston Scientific, Clearnote, Morphic, Q'Apel, W.L. Gore. Read More