Roche Diagnostics International Ltd. is joining forces with Bristol Myers Squibb Co. (BMS) to develop two new digital pathology algorithms to support cancer assay use in clinical trials. Roche Digital Pathology will create an artificial intelligence (AI) based image analysis algorithm to assist pathologists in interpreting the company’s FDA-approved Ventana D-L1 (SP142) assay for urothelial carcinoma patients. BMS will use the algorithm to generate biomarker data from clinical trial samples. Read More
Pavmed Inc. implanted its Portio system in three patients in a first-in-human (FIH) study of its intraosseous infusion system and successfully infused fluids in all patients without complications. The Portio system allows long-term direct access to bone marrow for delivery of fluids, medications and other substances in individuals with poor venous access, kidney dialysis or adverse reactions to anticoagulants. Read More
LONDON – A U.K. trial has shown it is possible to seamlessly insert point-of-care genotype testing for a rare genetic variant that causes hearing loss into the current care pathway in neonatal treatment for sepsis. Read More
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works. Read More
Zeta Surgical Inc. has raised $5.2 million in seed funding to improve the accuracy and safety of image-guided surgical procedures through its Zeta neurosurgical navigation platform. Zeta CEO Jose Maria Amich told BioWorld the funding will also advance a non-invasive ultrasound system for imaging the brain and help complete initial clinical studies for its FDA approvals application. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cutera, HLT, Lazurite, Sky Medical. Read More
