Latest News from FDA Reporter

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

Regulation

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 launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

By Princess Jade Barrenechea | Feb 1, 2020

Interactive tool offers information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief program

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

By Press release submission | Feb 3, 2020

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

By Press release submission | Feb 4, 2020

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

By Press release submission | Feb 4, 2020

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

By Press release submission | Feb 7, 2020

“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

By Press release submission | Feb 7, 2020

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

By Press release submission | Feb 8, 2020

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

FDA, State Regulators, Paula's Choice, Colgate-Palmolive, Mary Kay and Amway to Discuss Cosmetic Compliance in Los Angeles this April

Regulation

By Press release submission | Feb 8, 2020

Add Teaser here

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

By Press release submission | Feb 9, 2020

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

By Press release submission | Feb 10, 2020

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

Regulation

By Press release submission | Feb 11, 2020

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

By Press release submission | Feb 12, 2020

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.

HYPERFINE: World’s First Bedside MRI System Receives FDA 510(k) Clearance

By Press release submission | Feb 12, 2020

Novel MRI system is a breakthrough in patient accessibility and cost

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

By Press release submission | Feb 12, 2020

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

By Press release submission | Feb 13, 2020

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