Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas. Read More
Organox Ltd. gained approval from Health Canada for its Metra system for use during liver transplantation. The system utilizes normothermic machine perfusion to maintain donor livers under physiologic conditions prior to transplantation. Read More
Medtronic plc reported a voluntary recall of certain insulin pumps after customers said a single drop, bump, or physical impact could shorten their battery life. Read More
Researchers from Johns Hopkins University have filed for protection of their Optimal Target Identification via Modelling of Arrhythmogenesis technology – a method that builds a model of a patient’s heart from a cardiac MRI. Read More
Med-tech fundraising saw strong growth in 2024, with companies raising $21.24 billion in the first three quarters, a 48% increase over the $14.36 billion raised during the same period in 2023. However, September’s total dropped to $982.44 million, down from $3.67 billion in August. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3X4 Genetics, Aero Pump, Alpine Laser, Amphix Bio, International Longshoremen’s Association, Machine Solutions, Resyca, United States Maritime Alliance. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exact Sciences, GE Healthcare, Infinitt, Orthalign. Read More
