Organox Ltd.’s normothermic machine perfusion device, Metra, has been cleared by the U.S. FDA for use during air transport. The greenlight from the regulatory body paves the way for the broader use of donor organs that might otherwise be discarded, as the Metra system circulates oxygen and nutrient rich perfusate through the organ at near-body temperature, extending preservation times.
A committee of the House of Representatives advanced a bill that if passed will give eligible breakthrough medical devices four years of Medicare coverage.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argá Medtech, Medical Care Technologies, Renalytix, Roche, Tempus AI, True-See, T Rx Capital.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kelyniam, Medtronic.
A new generative AI model trained on UK Biobank data can simultaneously forecast the risks and timing of developing over 1,000 different diseases a decade into the future. The developers applied similar algorithmic concepts to those used to develop large language models like ChatGPT and Gemini to build the model, using medical records from 402,799 participants in UK Biobank.
A late-breaking study presented at the PERT Consortium 2025 Pulmonary Embolism Scientific Symposium in San Diego showed marked clot-burden reduction with no device-related serious adverse events for Imperative Care Inc.’s Symphony thrombectomy system, though other companies have a head start. Circulation: Cardiovascular Interventions simultaneously published the study in an article titled “A Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial.”
An international team of researchers has successfully used Onward Medical N.V.’s ARC-IM therapy to develop a neurostimulation system that improves blood pressure stability in patients with spinal cord injuries. According to data from two studies published in Nature and Nature Medicine, the implanted system also led to durable reduction of hypotensive symptoms, resulting in an improvement in the quality of life of patients.
As is the case with the Made in China 2025 initiative, the Make in India program has at least a decade of history to look back on, with some benefits accruing to the nation’s med-tech sector. All the same, Gunjan Bagla, CEO of Los Angeles-based Amritt Inc., told BioWorld that the initiative could be more successful if the legislature would tweak the laws to create a more helpful environment for industry.
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