Third-party testing of medical devices is an established practice, but some testing labs are more reliable than others. The U.S. FDA has warned device manufacturers that some of these labs are turning out falsified data in connection with such testing, calling out labs located in China and India as unusually suspect sources of testing data.
Through its intellectual property holding company, Eindhoven, the Netherlands-based Bambi Medical BV is seeking patent protection for an enhancement to its flexible sensor belt that is worn around the abdomen for monitoring the vital signs of neonates.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon, Athletic Heart, BD, Camtech Health, Diacarta, Dynocardia, Hyperfine, Route 92, Theranica.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sira Medical, Zylox-Tonbridge.
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
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