Nurse Assist Recalls Saline Flush Syringes
Nurse Assist Inc. is recalling its normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.
According to the U.S. Centers for Disease Control and Prevention, the effects of Burkholderia cepacia on people vary widely but can include serious respiratory infections, especially in patients with cystic fibrosis.
FDA Will Post Faster Recall Information
The FDA announced that it will post information in the searchableand the much earlier than previously — at the time a firm takes a correction or removal action and notifies the agency, rather than at the time of the FDA’s recall classification.
This change will help minimize confusion among patients and health care providers from a delay between when a firm initiates a correction or removal action and when the FDA announces the recall classification. It should also assist firms that are seeking information about legally marketed medical devices.
FDA Renews Technical Electronic Product Radiation Safety Standards Committee
The FDA announced the renewal of the Technical Electronic Product Radiation Safety Standards Committee for an additional two years beyond the charter expiration date. The committee provides advice to the FDA for setting standards for radiation emissions from electronic products. The new charter will be in effect until December 24, 2018.
Anika Therapeutics Scores CE Mark for Tendon-Injury Treatment
Bedford, Massachusetts-based Anika Therapeutics, Inc. has won CE Mark for its Orthovisc-T, indicated to relieve pain and restore function of tendons damaged by chronic injury and overuse.
Orthovisc-T is designed to provide lubrication and encourage tendon gliding. It is administered via injection into the site of injury.
FDA and Health Canada Approve OneTouch Vibe Plus Insulin Pump
Animas Corporation, a division of the Johnson & Johnson Diabetes Care Companies, has gained FDA Clearance and Health Canada’s authorization for its OneTouch Vibe plus insulin pump and continuous glucose monitoring system for the treatment of patients age two and older living with diabetes.
The transmitter collects blood glucose readings from the sensor and sends them to the patient’s insulin pump screen and compatible mobile device systems and app.
FDA Grants Marketing Clearance to Cepheid’s Next-Generation Test for MRSA Colonization
Sunnyvale, California-based Cepheid received clearance from the FDA for Xpert MRSA NxG methicillin-resistant Staphylococcus aureus (MRSA) infection control test.
Xpert MRSA NxG is a molecular test that delivers results in about an hour. The test has been validated for use with both ESwab (Copan) and rayon swabs.
Iradimed Corporation Scores FDA Clearance for MRI Compatible IV Infusion Pump
Winter Springs, Florida- based Iradimed Corporation received FDA clearance for its MRidium 3860+ magnetic resonance imaging (MRI) compatible IV infusion pump system, including its dose error reduction system software feature.
The compatible IV infusion pump system has been designed with a non-magnetic motor and other feature in order to deliver anesthesia and other IV fluids during MRI procedures.
FDA Grants Marketing Clearance to SalutarisMD’s RBS System
Tucson, Arizona-based Salutaris Medical Devices, Inc. has received marketing clearance for its SMD-Sr90-DA Radionuclide Brachytherapy Source (RBS), which is used within a manual brachytherapy applicator system.
The SMD-Sr90-DA RBS device is indicated for episcleral brachytherapy. The patented technology delivers a single-use brachytherapy procedure.