The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.
The U.K.’s National Institute for Health and Care Excellence is revisiting its policy for osteoporosis and may recommend that clinicians include vertebral fracture assessment with dual energy X-ray absorptiometry procedures.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brainsway, Cerevasc, Compremium, Lucid Diagnostics, QT Imaging, Venus Concept.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Machina Medical, Omnia Medical, Sonomotion, Surgentec, Truvian Health.
Abbott Laboratories received CE mark in Europe for the Tactiflex Duo ablation catheter to treat patients with atrial fibrillation. The first commercial cases using Tactiflex Duo, a dual energy device, were completed in the EU this week.
Investors continue to pour capital into AI-driven health care technologies, from drug discovery and diagnostics to personalized medicine and clinical decision-support tools. However, there remain issues with the quality and reliability of the data underpinning these systems, as well as the viability of their business model.
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