The U.S. FDA has posted the long-awaited final rule for lab-developed tests, which amends the draft rule in a few key respects, but Reps. Diana DeGette and Larry Buchson, once again voiced their opposition to the rule. DeGette and Bucshon acknowledged that congressional inaction has left the FDA with few choices, but called again for passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which they said is critical because “burdensome regulation of these medical products creates uncertainty in the future of innovation and patient care.” Read More
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market. Read More
Abbott Laboratories received U.S. FDA approval for its Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system for use in chronic limb-threatening ischemia well ahead of the expected second half 2024 time frame. Esprit showed clear superiority to angioplasty in the LIFE-BTK trial presented at last year’s Transcatheter Cardiovascular Therapeutics conference and published in The New England Journal of Medicine. Read More
Integra Lifesciences Holdings Corp. will not launch any new product in the EU before the U.S. because of the challenging requirements under the new Medical Device Regulation, Stuart Hart, chief medical officer at the Princeton, New Jersey-based company, told delegates at the LSX conference in London. Read More
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them. Read More
Lund, Sweden based-Paindrainer AB received notification from the European Patent Office that it intends to grant this patent application for its digital tool, Paindrainer, which coaches users in managing their pain and provides guidance on how to reach a personalized activity balance to reach an optimal functional level and alleviate pain. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Bio-Techne, C2N Diagnostics, Donaldson, Hermes Medical, Ivantis, Medica, Mediford, Ossdsign, Spectrum Dynamics, Thermo Fisher. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Labs, Clearpoint Neuro, Labcorp, Leica Biosytems, Sectra. Read More
