Makers of biotech therapies and in vitro diagnostics may be understandably weary of hearing about patent subject matter eligibility under Section 101 of the Patent Act, but Sen. Thom Tillis (R-N.C.) is prepared to take another swipe at the problem. Tillis announced Aug. 3 that the Patent Eligibility Restoration Act of 2022 is intended to reverse some of the deleterious effects of U.S. Supreme Court jurisprudence on Section 101 questions, a proposal that may be the last, best chance to address what many believe is a fundamentally broken judicial understanding of subject matter eligibility.
The controversies over the use of ethylene oxide (EtO) as a medical device sterilant were quelled by the COVID-19 pandemic, but the U.S. Environmental Protection Agency (EPA) has resurrected the issue.
Spintech MRI Inc. raised $6.5 million in series A financing to expand deployment of MRI software designed to improve and accelerate diagnosis and treatment of Parkinson’s disease, Alzheimer’s and other neurological diseases. The FDA-cleared Strategically Acquired Gradient Echo (Stage) platform is currently in use at more than 50 U.S. hospitals and institutions, including the Yale School of Medicine for advanced research, analysis and treatment of Parkinson’s disease.
Tears shed today by patients frustrated by an inability to obtain a diagnosis could speed diagnoses for others in the future. Researchers at Wenzhou Medical University, China, have developed a new nano membrane system, dubbed I-Tears, that harvests and purifies tiny droplets called exosomes from tears, allowing rapid analysis for disease biomarkers.
Bio-Rad Laboratories Inc. signed a $170 million deal to acquire all the outstanding shares of molecular diagnostics subsidiary Curiosity Diagnostics SpZoo from Scope Fluidics SA. The deal consists of approximately $100 million in cash and up to $70 million in future milestone payments. The pre-commercial platform company is the developer of a CE-marked 15-minute point-of-care (POC) rapid PCR system which tests for SARS-CoV-2 virus and methicillin-resistant or-sensitive Staphylococcus aureus bacteria (MRSA/MSSA).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ICU, Smiths, Twist.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytosorbents, Establishment, Fresenius, Mindpeak, Tribun Health, Vela.
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