The doctrine of inherent disclosure is not one of the more common methods for invalidating patent claims, but this doctrine led the U.S. Court of Appeals for the Federal Circuit to declare that several claims found in a patent held by Carl Zeiss X-Ray Microscopy Inc. are invalid.
EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle.
The U.S. FDA issued general correspondence letters to two device testing labs located in China. This is the latest in a series of moves by the agency to crack down on falsified or otherwise invalid device testing data.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antylia Scientific, 23andMe, BD, Cardiosense, Smith+Nephew.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robotica, Distalmotion, Empatia, Hyperfine, Olympus.
GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
Salvia Bioelectronics BV raised $60 million in a series B financing round for its minimally invasive implantable neuromodulation device, Mysalvia therapy, which treats chronic migraine. The funds will be used for clinical trials and obtaining regulatory approvals in the U.S., Europe and Australia.
The controversy over budget scoring by the Congressional Budget Office (CBO) once again prompted legislation that would overhaul the membership of a health advisory panel that may affect legislation dealing with the Medicare program. The Health Panel Act of 2025 requires the panel be composed of six members each appointed by Republicans and Democrats. The bill's sponsor said this is crucial to ensure diversity of political views, which is said to be lacking as the panel is currently constituted.