Monday, March 30, 2020

Monday, March 30, 2020

Latest News

AAO: Reports Congressmen Write Letter to the FDA and FTC Regarding SmileDirectClub, While California Board of Dentistry Moves to Dismiss SmileDirectClub's Lawsuit

The American Association of Orthodontists (AAO) - in the interests of the health, safety, and well-being of patients seeking orthodontic care - reports that on January 6, nine members of the U.S. House of Representatives authored a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) "to express [their] concern regarding SmileDirectClub."

GOJO: Takes Immediate Action on Communication from the FDA

GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.

SONY: Announces FDA Clearance for NUCLeUS, the Smart Operating Room Platform, for Sale in the U.S.

Sony Electronics has received FDA 510(k) clearance from the Food and Drug Administration for the company's NUCLeUS™ Operating Room, Imaging Management and Collaboration Control platform.

HONEST GLOBE: Elixicure CBD-Infused Pain Relief Product Listing Receives FDA Certification

Elixicure's Over-The-Counter Drug Registration has been Certified by the U.S. Food and Drug Administration (FDA) for its Elixicure CBD-Infused Pain Relief products following a successful year-long process, announced Elixicure Chief of Business Development Yaniv Kotler.

U.S. FDA: FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans

The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.

KOURA: 'Green' Medical Propellant Receives FDA Approval to Proceed to Clinical Trials

Koura's Zephex® 152a facilitates greater than 90% reduction in inhaler carbon footprints compared to current MDIs

CARDIOFOCUS: Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.

U.S. FDA: FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals

“Genome editing is a groundbreaking technology used to introduce intentional genomic alterations in animals and has the potential to improve human and animal health, animal well-being and to enhance food production and quality. It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness.

U.S. FDA: FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.

CAPTION HEALTH: FDA Grants Caption Health Landmark Authorization for First AI-Guided Image Acquisition System

Caption Guidance™ uses artificial intelligence to empower medical professionals without specialized training to perform cardiac ultrasound

EYEYON MEDICAL: Breakthrough Device Designation Received From the FDA for EndoArt®

EyeYon medical Ltd. announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its EndoArt®, Artificial Endothelial Layer Implant.

INTERNATIONAL ISOTOPES INC.: Announces U.S. Food And Drug Administration Approval Of Their ANDA For Sodium IODIDE I-131

International Isotopes Inc. (OTCQB: INIS) (the "Company") is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA) for its SODIUM IODIDE I-131 pharmaceutical product.

SOLITON: Files Special 510(k) with FDA for its Generation II RAP Device

Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that it has filed for Special 510(k) Premarket Notification with the U.S. Food and Drug Administration ("FDA") for its Generation II Rapid Acoustic Pulse ("RAP") device.

BAXTER INTERNATIONAL: Baxter and COSMED Announce U.S. FDA 510(k) Clearance of Q-NRG+ Indirect Calorimetry Device

Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) clearance of Q-NRG+, a metabolic monitoring device utilizing indirect calorimetry (IC) technology.

CARELIGHT: Introduces Line Of FDA-Cleared Light Therapy Devices; Recognized Industry Leader Joins Sales Team

CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the public. Inspired by Nobel Prize-winning science, Light Therapy devices are backed by years of scientific research and are FDA-cleared to reduce pain and increase circulation.

ORTHOFIX: Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators

App designed to facilitate patient compliance and improve outcomes now captures Patient Reported Outcome Measures

SOLIGENIX: FDA Grants Soligenix "Fast Track" Designation for RiVax® in the Prevention of Ricin Poisoning

Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).

FDA Reporter