Diagnostics startup Geneoscopy Inc. said Tuesday it has completed a PMA submission for its noninvasive, stool-based, at-home screening test for the detection of colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals. The filing is based on positive results from the company’s pivotal CRC-PREVENT trial that met all primary outcome targets, including sensitivity and specificity for CRC and AA. Read More
For the second time in recent weeks, Apple Inc. has come out on the losing side of a patent dispute adjudicated by the U.S. International Trade Commission (ITC), this time at the hands of Masimo Corp. While an ITC administrative law judge (ALJ) found for Masimo in connection with one of the company’s patents, Cupertino, Calif.-based Apple was cleared of any infringement in connection with four other Masimo patents, and the ITC has yet to officially declare what sort of remedy it will impose on Apple over the dispute with Irvine, Calif.-based Masimo. Read More
Oncohost Ltd., Baylor Scott & White Research Institute and the Translational Genomics Research Institute (TGen) have joined forces in a five-year study to improve personalized cancer therapy by better understanding resistance mechanisms. The team will analyze host response, patient microbiome, tumor DNA and immune system activity of 350 patients with non-small cell lung cancer (NSCLC). Read More
A U.K. real world nationwide study of the clinical effectiveness of hybrid close loop (HCL) insulin administration systems has found they improve glycemic control in type 1 diabetes compared to the earlier generation of devices. Read More
Shenzhen Core Medical Technology Co. Ltd. completed a series C round to speed up the development of its left ventricular assist devices (LVAD) for heart failure. Read More
The volume of med-tech deals and M&As dropped in the fourth quarter of 2022, although it was a solid year for both types of transactions due to a growing interest in the digital health space. Read More
Depuy Synthes Inc., of Raynham, Mass., has agreed to pay $9.75 million to settle allegations that several members of its sales team had induced an orthopedic surgeon to use the company’s products in orthopedic procedures by offering free implants and surgical instruments. The fine comes under the guise of a False Claims Act violation but might have been substantially larger but for the fact that Depuy reported the issue to federal authorities. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Bioventrix, Daiichi Sankyo, Ibex Medical, Rejuve.AI, Thermo Fisher, Trudiagnostic. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icotec. Read More
