Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see. Read More
Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology. Read More
HONG KONG – To boost the competitiveness of its medical device industry, South Korea will invest ₩1.2 trillion (US$10.3 billion) in medical device R&D over the next six years. Despite some high expectations for the new support, there are concerns about inefficient budget execution, and that the scheme is too short a term. Read More
The draft rules for the Stark and Anti-Kickback statutes (AKS) seem to have excluded makers of devices, but Meena Datta of Sidley Austin told BioWorld MedTech that while these agencies have plenty of reasons to rethink that notion, the final rules are unlikely to emerge in 2020 simply because of the complexity of the undertaking. While the final rules may reverse the drafts’ exclusion of makers of devices and diagnostics, device makers were upbeat at the prospect that they could engage in value-based payment arrangements with providers. Read More
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. Read More
