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
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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
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.
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.
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: 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: 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.
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.
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.