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. Read More
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. Read More
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. Read More
The U.S. FDA’s new draft guidance for the voluntary incorporation of patient preference information (PPI) in device development says that PPI would be included in product labels for cleared or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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Aspira Women’s Health, Bioreference Health, Genomenon Genomoncology, Harbinger, Microbiologics, Movano, Naitive, Opko Health, Parvizi Surgical Innovation, Sensid. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Hyperfine, Zeta Surgical. Read More
