Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach.
Palmetto GBA of Columbia, S.C., issued a draft local coverage determination that provides coverage for biomarker testing to stratify a patient’s risk associated with ductal carcinoma in situ.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Fluoguide, Olympus, Prophase, Radiology Oncology Systems, Raysearch, Zimvie.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Medtronic, Seimens, Spirair, Takeda.
Heartflow Inc. continued the steady rhythm of med-tech companies filing to go public, with an S-1 submitted to the U.S. SEC on July 17. The company joins 15 others that have completed IPOs in 2025 and one other in process – Carlsmed Inc., which a company spokesperson told BioWorld is expected to begin trading on the Nasdaq on July 22.
Xeltis BV is seeing encouraging preliminary data for Xabg, its coronary artery bypas conduit, from two clinical trials underway in Europe and South America. The data shows positive safety and patency in patients with multi-vessel atherosclerotic coronary artery disease.
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