The studies will assess the performance of its HLT Meridian® TAVR® Valve System to treat aortic stenosis and aortic regurgitation for high-risk patients suffering from aortic disease MAPLE GROVE, Minn. (March 24, 2022) – HLT Inc., a Bracco Group Company and a leader in the development of cutting edge transcatheter aortic valve replacement (TAVR) therapy, announced today that it has received U.S. […]
U.S. Food and Drug Administration approval of a clinical trial of Cardialen’s low-energy defibrillation and cardioversion therapy expands the number of leading clinical institutions evaluating its promising MultiPulse™ Therapy. Minneapolis, Nov. 17, 2021 – Cardialen, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin a […]
OTC Hearing Aid Act designed to offer greater public access to hearing aids at a lower cost Intricon well positioned to provide the ecosystem necessary to deliver high customer satisfaction ARDEN HILLS, Minn., Oct. 20, 2021 (GLOBE NEWSWIRE) — Intricon Corporation (NASDAQ: IIN), a joint development manufacturer of micromedical technology for use in interventional, implantable, and body-worn […]
PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large […]
U.S. FDA approves pre-filled syringe packaging for the macrocyclic gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine). Clariscan has been approved in more than 70 countries globally, with more than seven million patient doses shipped, and now offers a wider range of packaging solutions. Clariscan in pre-filled syringes offers potential advantages for workflow safety and efficiency. GE […]
U.S. Food and Drug Administration issued the following announcement on Nov. 6. The U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The […]
• U.S. commercialization expected to begin in the first half of 2021 • Continues positive momentum for Mainstay, with increasing commercial footprint in Europe and expected launch in Australia in early 2021 Dublin – Ireland, 22 June 2020 – Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) […]
Rebiotix and Ferring are the first to announce positive preliminary results on primary efficacy endpoint from ongoing pivotal Phase 3 clinical trial for RBX2660 RBX2660 is an investigational, non-antibiotic, microbiome-based therapy, developed to reduce Clostridiodes difficile (C. diff) infection recurrences CDC defines C. diff as a major burden to patients and doctors and an urgent […]
PhysIQ announces FDA-sanctioned labeling to address the COVID-19 public health emergency with its proprietary Multivariate Change Index (MCI) Deployed within the pinpointIQ® continuous remote monitoring solution, physIQ’s MCI will be used to proactively monitor homebound patients with or vulnerable to COVID-19 The sophisticated, machine learning-based algorithm uses multiple continuous vital signs from wearable sensors to detect […]
MINNEAPOLIS, June 17, 2019 /PRNewswire/ — Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation. This designation not only validates the clinical importance of Bio-Techne’s EPI test, […]