FDA Approval

HLT®, Inc. Gains FDA Approval for Two TAVR Clinical Studies

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. […]

Cardialen Receives FDA Approval to Conduct Clinical Trial of Low-Energy Atrial Fibrillation Treatment

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 […]

Intricon Applauds FDA’s Proposal to Improve Access to Hearing Aid Technology for Millions of Americans, Paving the Way for Over-the-Counter Hearing Aids

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 […]

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma

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 […]

GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan™ (Gadoterate Meglumine) in Pre-Filled Syringes

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 […]

FDA: Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

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 […]

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

• 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 announce world’s first with positive preliminary pivotal Phase 3 data for investigational microbiome-based therapy RBX2660

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’s Proprietary Personalized Analytics to be Used for COVID-19 Care with Newly Broadened FDA Labeling

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 […]

FDA Grants Breakthrough Device Designation to Bio-Techne ExoDx™ Prostate Intelliscore™ (EPI) Test

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, […]