Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
Samsara Vision Inc. has received FDA approval to begin a U.S.-based PMA supplement trial to assess improvements in visual acuity and safety of its smaller-incision next-generation implantable miniature telescope, called SING IMT, in people with late-stage age-related macular degeneration (AMD). The device has been available in the EU since 2020.
Cefaly Technology sprl reported results from a phase III clinical trial showing that two-hour treatment with its Cefaly Dual external trigeminal nerve stimulation (e-TNS) device is a safe and effective nonpharmaceutical option for acute migraine treatment in a nonhospital setting.
Vivosense Inc. aims to improve clinical trial recruitment and outcomes by developing new digital biomarkers and clinical outcome assessments (COAs) that use data from wearable devices, a goal made a touch easier by its successful completion of a $25 million series A financing round. The company’s platform is designed to detect and rigorously interpret subtle shifts in physiology using body-worn sensors.
With an eye on promoting innovation in complex innovative trial designs, the U.S. FDA published a series of case study examples Jan. 18 from its CID Pilot Meeting Program.
Olga Torres, co-owner of Miami-based Unlimited Medical Research, pleaded guilty Jan. 12 to obstructing a 2017 FDA inspection in connection with an alleged scheme to falsify data in a clinical trial evaluating an asthma drug for children.