Latest News
AACC: As U.S. Struggles to Get Coronavirus Testing Up and Running, AACC Calls on FDA to Allow Clinical Labs to Develop Their Own Tests for the Virus
In a letter to the Food and Drug Administration (FDA), AACC is urging the agency to allow clinical laboratories to develop coronavirus tests without going through FDA review.
COMPANION MEDICAL: FDA Clears InPen Diabetes Management System for Fixed Dosing and Meal Estimation
Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose according to the 2019 Seagrove Partners' Patients Perspectives Report.
FDA: Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized
To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA is recommending that consumers and health care providers follow the cleaning instructions provided by the CPAP’s manufacturer, which normally include regular cleaning with soap and water.
INNOCOLL HOLDINGS LIMITED: Resubmits New Drug Application to FDA for XARACOLL® for the Management of Postsurgical Pain after Open Inguinal Hernia Surgery
Innocoll anticipates a 6-month review by the FDA.
FDA: Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries
LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site.
FDA: Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome
The U.S. Food and Drug Administration today authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability.
FDA: Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications
Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications.
U.S. FDA: FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process
The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch.
BLUEGRASS VASCULAR TECHNOLOGIES: FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System
First device to reliably and repeatedly achieve central venous access from the inside-out in patients with venous obstructions
PULSE BIOSCIENCES: Provides Update on FDA 510(k) Submission for the CellFX System in Dermatology
Schedules Business Update Call on February 18, 2020 at 2:00pm PT
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).
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
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.
HYPERFINE: World’s First Bedside MRI System Receives FDA 510(k) Clearance
Novel MRI system is a breakthrough in patient accessibility and cost
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.
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.
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.
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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.
