Laborie Medical Technologies Inc. continued a string of recent deals with an agreement to acquire Urotronic Inc. for $255 million cash up front with an additional $345 million in payments contingent on meeting specified commercial and reimbursement milestones. Laborie already held a minority interest in the manufacturer of the Optilume drug-coated balloon technology for treatment of urethral strictures and benign prostatic hyperplasia (BPH). Read More
Ibex Medical Analytics Ltd. closed a $55 million series C financing round that will allow the company to expand its footprint in the U.S. to meet the increasing demand for artificial intelligence (AI)-powered diagnostic solutions. Ibex has developed the Galen platform which offers AI solutions that allow pathologists to accurately and rapidly detect and diagnose cancer. The company also reported the launch of Galen Breast HER2, a new software which will play a critical role in helping oncologists identify effective therapies for breast cancer patients. Read More
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions. Read More
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee. Read More
Pacira Cryotech Inc. reported the filing of a patent for a hand-held cryogenic treatment system with a probe configured to apply a cryogenic therapy to one or more nerves, such as the nerves of the stellate ganglion and autonomic tissue peripheral to the stellate ganglion. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ciliatech, Istar Medical, Lucid Diagnostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Body Vision, Click, Endologix, Indivior, Mediflex, Paige AI Inc., Profound Medical, Scipher Medicine, Strata Oncology. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveofit, Boston Scientific, Implantica. Read More