In a move that stunned and dismayed analysts and investors, Masimo Corp. announced a definitive agreement to acquire Sound United LLC Tuesday evening for $1.025 billion. Masimo’s stock (NASDAQ:MASI) plunged on the news of its intended purchase of the high-performance consumer audio products company, plummeting 39% from $228.84 at Tuesday’s close to $139.60 at Wednesday’s opening bell. Volatility led the Nasdaq to suspend trading in the stock for four minutes before 10 am. The stock recovered slightly during the day to close Wednesday at $147.00. Read More
The selection of Robert Califf to run the U.S. FDA might seem like a safe move on the part of the White House, but some believe his prior experience at the FDA does not necessarily suggest an acceptance of the regulatory status quo. Peter Pitts, president of the Center for Medicine in the Public Interest, told BioWorld that while Califf is “not a flashy pick,” Califf possesses a very keen understanding of the need to modernize the FDA’s practice of regulatory science, which should be a welcome bit of news for makers of drugs and devices. Read More
PARIS – Companion Spine SAS has raised $55 million to help develop its noninvasive diagnostic and interventional implant solutions for the treatment of degenerative disc disease and lumbar spinal stenosis. This series A round was led by Viscogliosi Brothers LLC, a New York-based investment company specializing in financing disruptive technology in spine treatment. Read More
Collplant Biotechnologies Ltd. has signed a collaboration agreement with 3D bioprinting company Cellink AB for future commercial production of regenerative breast implants. Rehovot, Israel-based Collplant has developed prototypes of 3D bioprinted implants and is evaluating them in preclinical studies. The regenerative implants are designed to degrade over time and be replaced by new, naturally grown breast tissue. The technology aims to overcome the challenges of existing breast procedures that use silicone implants or autologous fat tissue transfer. Read More
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR). Read More
Most of the better-known targets of prosecution under the U.S. False Claims Act (FCA) are drug and device manufacturers, but the Department of Justice (DOJ) seems to have opened a new front in the war on Medicare fraud. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axim Biotechnologies, Endonovo, Genome Explorations, Imbed Bioscience, Invo Bioscience, Iul, Magellan Diagnostics, Meridian Bioscience, Nanotemper, Spartan Medical, T2 Biosystems, Tesis Biosciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guard Medical, Rapid Medical, Tandem Diabetes Care. Read More
