February 3, 2017

bioMerieux Recalls Reagents And Accessory Products

bioMerieux is recalling the NucliSENS reagents and accessory products due to a quality problem of the magnetic silica (MagSil) component.

MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis.

The distribution dates are from May 03, 2016 to August 18, 2016.

Neural Analytics Receives CE Mark for the Lucid System

Los Angeles–based, Neural Analytics has gained a CE Mark for its advanced ultrasound device, the Lucid M1 transcranial doppler ultrasound system (lucid system), which is a portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders.

The device system is a battery-operated, medical-grade tablet. It uses a type of ultrasound called transcranial doppler to assess the brain’s blood vessels from outside the body.

The device received FDA marketing clearance in October 2016.

Cambridge Cognition Awarded FDA Marketing Clearance for Cantab Mobile

Neuroscience digital health company, Cambridge Cognition has achieved FDA marketing clearance for its Cantab mobile.

The device is designed to detect clinically-relevant memory impairment in older adults at the point of care. It includes a computerized test of visuospatial associative learning (CANTAB PAL) to assess episodic memory with optional mood and functional assessments.

The touchscreen test takes less than 10 minutes to complete.

Bard Peripheral Vascular Issues Recall for Halo One Thin-Walled Guiding Sheath

Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient’s leg.

The company also reports that the sheath may kink, and that its tip may become damaged during the procedure.

The device is used to introduce and/or guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient’s leg.

The distribution dates are June 24, 2016 to July 12, 2016.

FDA Grants Clearance to GEO Bone Screw System

Dallas–based, Gramercy Extremity Orthopedics (GEO) has received FDA marketing clearance for the GEO Bone Screw System.

The device can be used for bone fractures, osteotomies, arthrodesis, osteochondritis and tendon reattachments.