FDA Grants PMA Approval for Hologic Assay
Massachusetts–based, Hologic has received PMA approval from the FDA for its hepatitis C virus assay for measuring viral load and confirming infection.
The Aptima HCV Quant Dx assay uses real-time transcription-mediated amplification (TMA), which provides sensitive and specific performance for diagnostic use, and measures sustained antiviral response across all major genotypes.
The assay runs on the automated Panther system, which reduces hands-on time with random and continuous access.
The assay is CE-IVD marked for diagnostic and viral load monitoring in Europe.
Biolase Gains FDA Clearance for its All-Tissue Laser System
Biolase, has received FDA marketing clearance for its Waterlase Express all-tissue laser system.
The company said the product will be available to dentists in the U.S. as well as in Europe, the Middle East and Asia.
Health Canada Approves Medtronic’s Drug-Coated Balloon
Medtronic Canada has obtained a license from Health Canada for its IN.PACT Admiral drug-coated balloon.
The endovascular device is used in patients with peripheral artery disease in the thigh and behind the knee.
A compressed balloon is inserted into the artery, inflated to re-open the blockage and then removed. The device leaves behind medication that helps prevent the artery from narrowing.
Abbott Issues Recall on StarClose SE System Due to Potential Faulty Clip
Abbott Vascular has issued a recall of the StarClose SE Vascular Closure System. The device may fail to deploy the StarClose SE Clip, which can lead to prolonged surgical procedure times.
Abbott advised healthcare providers to immediately stop using the devices and return unused devices.
Biotronik’s Coronary Stent System Gets FDA Approval
Biotronik’s pro-kinetic energy cobalt chromium coronary stent system has gained FDA approval.
The device is designed to expand coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries.
The strut thickness of this stent allows for deliverability under the most extreme conditions of bended areas and calcification.
It is indicated for patients who have a blockage in arterial vessels between 2.25 and 4.0 mm in diameter and lesion lengths up to 31 mm.
CareFusion Issues Recall for Faulty Air-In-Line Sensor
CareFusion recalled the Alaris Syringe Pump because of a faulty air-in-line sensor which could generate a false alarm and cause the syringe pump to stop supplying an infusion to the patient, which could cause serious adverse health consequences or death.
The device delivers fluids such as nutrients, blood and medications in controlled amounts.