Expanse Ice Inc. received U.S. FDA clearance for its Ice Aspiration system, which is designed to clear blood clots in peripheral vessels. The system uses distal cyclical aspiration to “harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” Expanse Founder and CEO Eitan Konstantino said. Read More
The U.S. Federal Trade Commission’s final rule for noncompete clauses in employment contracts would seem to endanger life science patents and trade secrets, but there is a question of whether the agency stepped outside its statutory bounds in forming the rule. The U.S. Chamber of Commerce has already filed suit on the rule, but Joshua Rich of McDonnell Boehnen Hulbert & Berghoff LLP told BioWorld, that the Chamber is unlikely to be the last entity to file suit over the rule. Read More
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies. Read More
Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for analyzing cells in greater detail to better understand infection, immunity and other phenomena, and could lead to the development of new, more targeted treatments. Read More
The process of manufacturing autologous T-cell therapies is technically challenging when compared with other oncology drugs, making the overall cost of developing CAR T therapies significantly higher. A challenging reimbursement environment for drugs listed on China’s National Reimbursement Drug List also means that most patients will have to pay out of pocket to access CAR T therapies. Taken together, complex logistics – production, manufacturing and supply chain – and complicated administration requirements are key bottlenecks that inflate the input costs involved in developing these specialized treatment options. Read More
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism. Read More
New hires and promotions in the med-tech industry, including: Bioaffinity, Seed Health, Spectral AI, Spectral IP, Techwald, Valcare, Vantage Medtech. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blue Arbor, Cortechs.ai, Genembryomics, Progenesis, Scibase. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curio Digital, Novartis, Pillar Biosciences, SAIL Fusion. Read More
