Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Camdiab, Ypsomed.
The U.S. FDA has had its sights on artificial intelligence (AI) for some time, but an upcoming advisory hearing will review questions such as the regulatory status of a generative AI (GenAI) algorithm. This is just one of several AI-related dilemmas facing the agency in the next few years.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bruker, Icecure, Index International, Mammotome, Olympus, Orthofix, Quirugil, R3 Vascular, Seer, Thermo Fisher, Trinity Biotech, Venus Concept.
While the size of the market is enormous, drug development and treatments for women’s health care still lag behind what is offered for men. There has been a renaissance in the past few years, however, led by investors and companies that have wrestled with determining exactly what encompasses women’s health and how to meet its challenges.
Quanta Dialysis Technologies Ltd. received the greenlight from the U.S. FDA for the use of its portable dialysis system at home. The clearance brings a much-needed option for patients with end-stage renal disease to receive their treatment in the comfort of their own homes and without a rigid dialysis schedule.
The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or approved medical devices.
Almost a year after U.S. FDA approval of the first pulsed field ablation device for treatment of atrial fibrillation, Johnson & Johnson secured FDA approval for its Varipulse system, intensifying competition in the rapidly growing market.
The first patenting from Fibra Inc. sees its founder and CEO Parnian Majid describe their development of a non-invasive wearable device which tracks fertility data through the measurement of various physiological parameters.
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