Medtronic Issues Recall for Neurovascular Products
Medtronic is recalling of certain lots of its embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices.
The devices are designed to be used together for treatment of cerebral aneurysms.
The distribution dates are between Nov. 10, 2014 to Aug. 5, 2015.
FDA Approves Rodo Abutment System
Rodo Medical has received FDA clearance for the Rodo abutment dental system which has the shape-memory Smileloc retentive sleeve.
The sleeve combined with proprietary Rodo abutment and coping, uses Nitinol to create an attachment between a restoration and a dental implant, eliminating the need for cement or screws.
The system is used in tandem with compatible dental implant systems in the upper and lower jaw to retain crowns, bridges and over-dentures.
Quidel’s Solana(R) Molecular Assay Achieves FDA Clearance
Quidel has received clearance from the FDA to market its Solana herpes assay for the detection and identification of different types of herpes and varicella from lesion samples obtained from patients showing symptoms.
Solana can process up to 12 patient samples in each run.
The assay is not intended for use with cerebrospinal fluid or to aid in the diagnosis of herpes or varicella infections of the central nervous system nor in prenatal screening.
ConvertX Nabs FDA Clearance for Kidney Stent System
The FDA has cleared BrightWater Medical’s ConvertX kidney tube stent system for treatment of obstructions.
The device is implanted and converts from a catheter to a stent without the need for radiation or sedation. It then remains implanted in the patient like a standard internal kidney tube stent.
BrightWater Medical is will submit an application for the ConvertX system to the EU for CE marking.
QView Medical Get FDA PMA Approval for QVCAD
QView Medical has received FDA approval for QVCAD, which is a CAD system for automated breast ultrasound (ABUS).
QVCAD presents the CAD results, which include a C-thru navigator image and CAD marks indicating regions of interest, in tandem with the original ABUS image.
The QVCAD pivotal reader study submitted in the PMA application demonstrated that QVCAD reduces reader review time while preserving the accuracy of diagnosis.
Abbott Gains CE Mark for i-STAT Alinity System
Abbot has received CE marking for the i-STAT Alinity system, which is a portable blood testing platform available for sale in Europe.
The all-in-one device performs and analyzes a range of blood tests using only two to three drops of a patient’s blood. Results are delivered in two to 10 minutes.
The device is currently not available in the U.S.
Exact Imaging Receives CE Mark Approval For its ExactVu Micro-Ultrasound System
Exact Imaging has received CE Mark approval for its ExactVu micro-ultrasound system for prostate imaging and biopsy guidance.
The system’s high resolution is derived from its operating frequency of 29 MHz, which is more than double the operating frequencies of conventional ultrasound systems.
Due to the increase in resolution, the device system enables the urologist to view abnormalities clearer in the regions and perform biopsies.
Skyline Medical Wins Health Canada Approval for Streamway
Skyline Medical has won Health Canada approval for its Streamway medical fluid disposal device.
The device is an automated direct-to-drain medical fluid disposal system.
The company expects to reach a deal in the coming weeks to distribute the product across 1,500 hospitals in all 13 Canadian provinces.