Med-tech powerhouse Johnson & Johnson made a bold bid to bolster its interventional cardiology holdings with the news on April 5 that it is acquiring Shockwave Medical Inc. for approximately $13.1 billion including cash acquired. The $335 per share cash price represents a more than 5% premium to Shockwave’s (Nasdaq: SWAV) April 4 closing price. Read More
Paragonix Technologies Inc. expanded access to its U.S. FDA-cleared Baroguard donor lung preservation system following a successful limited release with a handful of top transplant centers. In addition to critical temperature control, the new system provides active airway management to keep donor lungs in the best condition possible. Read More
Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor. Read More
In what represents its first patenting, Halifax, Nova Scotia-based Hollo Medical Inc. seeks protection for its product that is designed for inhaler users who are frustrated with cumbersome valved holding chambers and desire something more compact and portable. Read More
After decades of trying and dozens of failed trials, amyloid targeting has paid off with the first disease-modifying agents reaching the market. But success does not mean slam dunk. Aduhelm (aducanumab, Biogen Inc.) was dogged by controversy throughout its brief tenure, and Biogen pulled the plug on it in early 2024. Leqembi (lecanemab, Biogen Inc.) has received full approval. In this second installment of a three-part series on Alzheimer’s, BioWorld looks at the nuanced view of amyloid’s role in the disease. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: California X-ray Imaging, Emboline, Luscii, Omron, Quantaix, Shimadzu, Sophia, Strand Life Sciences, Swat Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Prenosisk, Sebia. Read More