EU Grants CE Mark for Intact Vascular’s Tack Endovascular System
Wayne, Pennsylvania–based Vascular Tack has attained the CE Mark for its Tack endovascular system for repairing arterial dissections following percutaneous transluminal angioplasty (PTA) below the knee.
The design of the device implant allows it to be used in arteries ranging from 1.5 mm to 4.5 mm in diameter. Unlike stents, which have to be precisely sized to the artery where they will be placed, the device adapts to the diameter of the artery.
FDA Clears SpineGuard’s DSG Integration Module to Market
SpineGuard has received FDA marketing clearance for its DSG (Dynamic Surgical Guidance) integration module for use in combination with Zavation’s spinal fusion system.
A DSG-enabled screw is a combination of a bipolar sensor and a pedicle screw in one device. The technology offers surgeons real-time guidance and the ability to insert the screw directly into a vertebra without drilling a pilot hole.
The DSG sensor differentiates various tissue types based on the analysis of the local electrical conductivity. Real-time feedback informs the surgeon of changes in tissue type by an audio signal varying in pitch and cadence. This alerts surgeons to potential breaches during screw placement.
Medasense Biometrics Nabs CE Mark for Pain Monitoring System
The European Commission has awarded a CE Mark for Medasense Biometrics’ pain monitoring device, PMD200.
This device allows post-operative care units to adjust the treatment of pain by avoiding the use of excess or deficiency of analgesics that may cause major complication. The system consists of a finger probe that receives and measures physiological signals from four different sensors. This data is then analyzed by algorithms and converted to reflect a pain index score.
MindChild Acquires FDA Marketing Clearance for Fetal Monitoring System
MindChild Medical has received marketing clearance for its Meridian M110 non-invasive fetal heart monitor.
The device measures and displays fetal heart rate, maternal heart rate, and uterine contractions, using abdominal surface electrodes to detect the fetal ECG, maternal ECG and uterine contractions.
FDA Grants Marketing Clearance to CyMedica Muscle Stimulation Device
Scottsdale, Arizona–based, CyMedica Orthopedics has received FDA marketing clearance for e-vive, a wireless muscle stimulation device that rehabilitates muscle strengthening for ACL and total knee replacement patients.
The device system is app-controlled and allows patients to be engaged with their rehab by tracking their progress and allowing data-sharing to clinicians.
Medtronic Wins CE Mark for 34mm Heart Valve
Medtronic has won a CE Mark for its CoreValveEvolut R 34 mm valve.
The Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with a diameter size ranging from 26-30 mm.
The valve is designed to fit in the native aortic valve and is delivered through the EnVeo R delivery catheter system.
Ventripoint Applies to Health Canada for Heart Analysis System
Toronto, Ontario–based, Ventripoint is seeking Health Canada’s approval for the expansion of its VMS heart analysis product to include the right atrium, left atrium and left ventricle chambers of the heart.
The expanded approval would allow the product to be used to determine the volume and function for all four chambers of the heart.