Approvals
HemoSonics’ New Diagnostic for Hemostasis System Gains CE Mark
HemoSonics has gained the CE Mark for its QStat Cartridge, allowing its Quantra Hemostasis System to be used in trauma surgery and liver transplants settings in hospitals.
The disposable cartridge offers a panel of blood tests for gauging clot time, clot stiffness, fibrinogen and platelet contribution to clot stiffness and clot stability to lysis.
All tests except the clot stability to lysis diagnostic take 25 minutes or less to produce results, which are read on a user-friendly dials interface that requires little training, the devicemaker said.
FDA Grants Breakthrough Status for Electrostimulation System
Checkpoint Surgical has earned the FDA’s breakthrough designation for its brief electrostimulation therapy system (BEST), a device designed to treat nerve injuries.
The device is intended to be used in combination with surgical intervention following nerve injury to speed up patient recovery.
BEST uses low-level electrical currents to stimulate a patient’s peripheral nerves and encourage nerve regeneration.
EBR Systems Nabs Breakthrough Status for Wireless Cardiac Pacing System
EBR Systems’ WiSE (wireless stimulation endocardially) cardiac resynchronization therapy (CRT) device has earned breakthrough designation from the FDA for treating heart failure.
The wireless device synchronizes the heart’s left and right ventricles to more efficiently distribute blood, improving its pumping ability. The system controls pacing through the use of a wireless electrode.
The system is implanted in the left ventricle wall in a minimally invasive procedure, giving better options for pacing locations.
Exact Imaging’s Transperineal Needle Guide Grabs CE Mark
Exact Imaging has received the CE Mark for its sterile transperineal needle guide for use with its EV29L transducer on the ExactVu micro-ultrasound system.
The device allows urologists to conduct targeted prostate biopsies using Exact Imaging’s micro-ultrasound device for transperineal-based biopsies.
The needle biopsies take prostate tissue samples for microscopic examination to look for cancer cells.
Netech Grabs FDA Clearance for Defibrillator/Pacemaker Analyzer
Netech has received 510(k) clearance for its Delta 3300 device, a defibrillator and pacemaker analyzer that tests and validates the functions of semi-automated and automated defibrillators.
The portable product also measures external pacemakers.
The device tests for various metrics, including energy, peak discharge voltage and the simulation of ECG and arrhythmia waveforms, among others.
Bardy’s 14-Day Ambulatory Cardiac Patch Monitor Cleared
The FDA granted Bardy Diagnostics 510(k) clearance for the 14-day version of its Carnation Ambulatory Monitor (CAM) patch, a wearable device used to diagnose arrhythmia and assist in patient management.
The extended wear version detects and records the P-wave, a small amplitude signal of the ECG originating in the heart’s upper chamber. The wave is important in accurately diagnosing arrhythmia, Bardy said.
The new version uses the same P-wave focused technology as the company’s two- and seven-day CAM patches. Its extended duration may help detect less frequent arrhythmias, the company said.
FDA Clears Masimo’s Updated Cerebral Oxygenation Monitor
The FDA has cleared additional measurements by Masimo’s O3 cerebral oxygenation monitor, enabling the device to show more information on changes in the blood used to calculate cerebral oxygen saturation.
The agency has cleared the indices for changes in deoxyhemoglobin, oxyhemoglobin, and the sum of deoxyhemoglobin and oxyhemoglobin.
The O3 uses spectroscopy to monitor cerebral oxygenation in situations where peripheral pulse oximetry may not fully indicate oxygen levels in the brain, the company said.
FDA Hands SoniVie Breakthrough Designation for PAH Treatment
The FDA granted SoniVie breakthrough device designation for its Therapeutic Intravascular Ultrasound (TIVUS) system in patients with pulmonary arterial hypertension.
The system, a dedicated ultrasound catheter, is placed in the pulmonary artery during a heart catheterization procedure to ablate nerves associated with the disease’s effects.
The debilitating, life-threatening rare disease occurs when patients have high blood pressure in the vessels that move blood from the heart to the lungs.
Occlutech Grabs CE Mark for Atrial Flow Regulator
Occlutech’s atrial flow regulator device has been cleared on the European market for treating heart failure symptoms through decompression.
The intra-atrial shunt is placed in the patient’s septum between the left and right atriums via a minimally invasive procedure to decompress abnormal pressure.
The device comes in a variety of sizes to allow individualized treatment.