The FDA has granted over-the-counter (OTC) clearance to the first noninvasive wearable to treat stress urinary incontinence. The device, known as Innovo, uses electrical stimulation to strengthen pelvic floor muscles and is integrated into fitted shorts. It was already available by physician prescription in the U.S. since an FDA clearance in early 2019.
Diabetes is the first med-tech sphere that is coalescing for Verily Life Sciences LLC, but cardiology could be next. The South San Francisco-based business that’s part of Google parent Alphabet Inc. has received a second FDA clearance for its Verily Study Watch as an irregular pulse monitor. After a 2017 debut, it was first cleared by the agency about a year ago for use to take an on-demand electrocardiogram (ECG).
Issy-les-Moulineaux, France-based Withings SA said it’s planning to launch its latest product in the U.S. and Europe during the second quarter, the Scanwatch. It is expected to be the first smartwatch to offer both atrial fibrillation (AF) and sleep apnea detection; a CE mark and FDA clearance are both pending. Cardiac arrhythmia and sleep apnea are associated with one another and can be precursors to more serious health problems such as heart attack or stroke.
BOGOTA, Colombia – A startup in Mexico has developed an intelligent glove to diagnose cardiac diseases in seconds just by touching a patient’s chest. The invention could become available on the market by the end of 2020, when Soluciones Kenko, from Jalisco, Mexico, expects to hit the Mexican market with a futuristic solution for the health care sector.
Roseville, Calif.-based US Kidney Research Corp., formerly Curion Research Corp., has been working on its waterless renal replacement technology since its inception in June 2015. Its latest research efforts using its novel blood purifying technology have led to the production of the first ‘synthetic urine,’ which mimics the body’s natural production and the kidney’s filtration capability.
Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch.
Tech giant Google LLC is taking aim at the Apple Watch with its plan to acquire wearables pioneer Fitbit Inc., of San Francisco, for $2.1 billion, or $7.35 per share, in an all-cash transaction expected to close sometime next year.
Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.
CLEVELAND – How are telemedicine and wearable technologies changing health care and how physicians see patients? That question was the focus of a panel that examined how such emerging technology can play a role in improving primary care. The panel took place during the Cleveland Clinic's 2018 Medical Innovation Summit and was part of the a series of discussions on how technologies, including digital health, are disrupting health care.
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