Approvals
ResApp Gains CE Mark for Respiratory Disease Diagnostic App
ResApp has earned the CE Mark for its ResAppDx-EU, a smartphone-based diagnostic test for acute pediatric respiratory disease.
The CE Mark was supported by data from a pediatric clinical study showing that the app’s cough-based diagnosis algorithms had “excellent agreement with a clinical diagnosis,” the company said.
The mobile software app is intended for use by clinicians to diagnose lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children.
Atrial Management Device Cleared for Expanded Labeling
The FDA granted AtriCure 510(k) clearance for additional labeling claims for its AtriClip left atrial appendage (LAA) management device.
The expanded clearance changes the indication from occlusion of the LAA to exclusion and adds electrical isolation as a labeling claim. Occlusion plugs the opening to prevent blood flow into the LAA, whereas exclusion shuts off or eliminates the appendage from the left atrium.
The agency granted the electrical isolation claim after testing showed that when excluding the LAA using the device, the appendage can no longer conduct electrical activity.
FDA Clears Biobeat’s Cuffless Blood Pressure Monitors
The FDA granted Biobeat 510(k) clearance for its blood pressure, oxygenation and heart rate patch and watch monitors.
The devices take away the need for an inflating cuff, enabling remote monitoring and cloud-based healthcare, with data transmitted using either WiFi, Bluetooth, radiofrequency or a smartphone.
The products are the first of their kind to receive FDA clearance, the company said. They previously gained the CE Mark.
Miracor Earns Breakthrough Designation for STEMI Heart Attack Treatment
The FDA granted Miracor breakthrough designation for its PiCSO (pressure-controlled intermittent coronary sinus occlusion) device for treating heart attacks in which a coronary artery is completely blocked.
The device is designed to clear coronary microcirculation by stopping blood delivery into the right atrium through the coronary sinus, to improve blood flow to the area of obstruction after a ST-elevation myocardial infarction (STEMI) heart attack.
ST elevation refers to a reading on an electrocardiogram where the trace is abnormally high. STEMI heart attacks are considered the “classic” heart attacks and occur when a coronary artery has become totally blocked, causing a large portion of the heart to stop receiving blood.
FDA Approves CVRx’s Advanced Heart Failure Treatment
The FDA granted CVRx approval for its Barostim Neo system, a technology designed to improve symptoms in patients with advanced heart failure who can’t be treated with other heart failure devices.
Advanced heart failure can cause fatigue, palpitation and shortness of breath, leading patients with the condition to receive no benefit from standard treatments.
The Barostim Neo was one of the first therapies to receive the FDA’s Breakthrough Device designation, which led to prioritized review of a phase 3 trial in 264 patients, which showed positive safety and effectiveness results.
OrthoPediatrics’ Foot Deformity Treatment Earns 510(k) Clearance
The FDA has granted OrthoPediatrics 510(k) clearance for PediFoot, a pediatric-specific system for treating foot and ankle fractures and deformities.
The device is intended for fixating fractures, osteotomies, non-unions, replantations, and small bone and bone fragment fusions in pediatric patients, including the feet, ankles, hands and wrists. It uses the company’s variable angle locking technology, which offers five points of fixation.
PediFoot addresses common deformities encountered in pediatric patients, including cavus foot, flatfoot, clubfoot and hallux valgus, the company said.