TGA Yanks Alere InRatio Monitors, Strips
Australia’s TGA is withdrawing from the market the Alere INRatio and Alere INRatio 2 PT/INR monitors, as well as the INRatio Test Strips due to innacurate test results.
However, Alere will continue to manufacture and distribute the test strips for a period of time to allow patients to safely transition to another monitoring method. Alere recommends that patients have periodic verification of their INR using a laboratory INR method as soon as possible.
UK Warns on Nipro Glucose Strips
The UK’s Medicines and Healthcare products Regulatory Agency warned people with diabetes to stop using Nipro Diagnostics’ TRUEresult glucose test strips due to a manufacturing fault that could lead to false low blood sugar results.
The manufacturer discovered an issue with the packaging of certain lots, and the test strips were not sealed properly. Read the warning here: www.fdanews.com/08-11-16-UKsafetyalert.pdf.
Boston Scientific’s Emblem MRI Approved
Boston Scientific received FDA approval for its Emblem MRI subcutaneous implantable defibrillator (S-ICD) system, as well as magnetic resonance conditional labeling for previously implanted Emblem S-ICD systems.
The Emblem MRI S-ICD System is a treatment option for patients at risk of sudden cardiac arrest, leaving the heart and vasculature untouched. Boston Scientific also received CE Mark approval for the system earlier this year.
FDA Clears Hammertoe Correction System
Centric Medical has been granted a 510(k) marketing clearance for a foot-phalange device for hammertoe patients.
The Hammertoe Correction System is a dual-threaded device and is placed between the proximal and middle phalanges, so that both threads grip the phalangeal canal of the toe and compress the joint. This is an alternative treatment to wire pins, which can break and dislodge.
InSeal Gets CE Mark for InClosure
InSeal Medical has received CE Mark approval for the InClosure vascular closure device.
The device’s technology is based on a biodegradable internal membrane that seals the puncture by using blood pressure to improve sealing.
InClosure is implanted percutaneously and requires no pre-procedure. The internal membrane fully biodegrades within several months of the procedure.
Medtronic Gets CE Mark for DBS Software
Ireland-based Medtronic received CE Mark approval for its SureTune2 software for use in deep brain therapy devices.
The software allows for patient-specific visualization during DBS therapy. The therapy device emits mild electrical stimulation to targets in the brain in order to modulate specific symptom control. SureTune2 is currently not approved in the United States.