The controversy over U.S. Medicare coverage of breakthrough devices is far from over as an administrative matter, but the House of Representatives is prepared to statutorily force the issue with a new bill that enjoys bipartisan support. The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 provides instant Medicare coverage upon FDA clearance or approval of the device, a feature of previous policy proposals that the CMS has found administratively problematic. Read More
Aural Analytics Inc. received a breakthrough device designation from the U.S. FDA for its Speech Vitals-ALS technology, a software application that collects and analyzes speech recordings to help monitor amyotrophic lateral sclerosis (ALS) in adults in clinic and home settings. The software could improve management of the devastating disease. Read More
Genialis Inc. reeled in $13 million in a series A financing co-led by Taiwania Capital and Debiopharm Innovation Fund. The funds will be used to build out the company’s store of clinically validated biomarker models for individualized cancer diagnosis. Read More
The U.S. FDA granted Graymatters Health Ltd. 510(k) clearance to market Prism for PTSD, a non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD). Read More
U.S. FDA commissioner Robert Califf went to Capitol Hill ostensibly to answer questions about the agency’s budget request for fiscal 2024, but the conversation quickly focused on issues such as baby formula and food supply security. Read More
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acumen Diagnostics, Ase Chung-Li, Astellas, Boston Scientific, Clearpoint Neuro, Endonovo, G Medical, Obo Pro2, Peak Pharmaceuticals, Retrieve Medical, Roche Diabetes Care, Scivita Medical, Sofpulse, Todos Medical, United Health, Usound. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Corelink. Read More
