A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through. Read More
Accunea Ltd. is looking to reduce the number of kidneys that are discarded with its bioanalysis technology Renosure, which can detect critical changes in organ function in real-time, both before and after transplantation. The company is looking to raise £1.6 million (US$2 million) to develop the device which could transform the lives of people requiring a kidney transplant. Read More
Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations are progressing heat-stable, dried-formulation mRNA vaccines using Vaxxas’ needle-free high-density microarray patch. Read More
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common. Read More
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field. Read More
Med-tech firms raising money in public or private financings, including: Grey Matter Neurosciences, Median Technologies, Neko Health, Semler Scientific, Xaga Surgical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Spine and Pain Management, Caranx Medical, Eneura, Grey Matter Neurosciences, Milestone Scientific, Recon Supply, Surgery Hero, Sword Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Saluda. Read More
