FDA Clears NimbleHeart’s Reusable ECG Device
NimbleHeart’s reusable ECG device, the Physiotrace Smart, received FDA marketing clearance.
The device wraps around the user’s torso, and is used without electrolytic gels or adhesives.
The unit is designed for independent home use. The mobile app displays the status of the device, the user’s heart rate, and ECG waveform during a recording session. The app also collects and manages data sent by the device, uploading it to the cloud for caregiver review.
FDA Approves Medtronic’s HeartWare HVAD for Advanced Heart Failure
Medtronic received the FDA’s approval for its HeartWare HVAD System for patients with advanced heart failure who are not candidates for heart transplants.
The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.
The HVAD System received FDA approval in 2012 as a bridge to transplant in patients eligible for heart transplants. It also received European CE Mark in that year for patients at risk of death from refractory, end-stage heart failure, and it previously had received CE Mark for the bridge to transplant indication in 2009.
FDA Clears First Zika Assay for Blood Supply
The FDA approved the first Zika virus detection test for screening blood donations.
The cobas Zika test, manufactured by Roche Molecular Systems, was approved last year for individual diagnoses of Zika virus infection under investigational new drug applications after the FDA issued final guidance in August 2016 on screening individual blood units for Zika virus.
Primarily transmitted by the Aedes aegypti mosquito, Zika virus can spread via a blood transfusion. The newly approved assay for the cobas 68000 and 8800 systems has helped to identify and remove more than 450 potentially infectious donations from the blood supply, according to Roche Diagnostics CEO Roland Diggelmann.
Sleep Apnea Device Wins FDA Approval
Respicardia won FDA approval for its Remedē System, a transvenous implantable neurostimulation system that engages the diaphragm to restore natural breathing during sleep in patients with central sleep apnea.
CSA disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing.
Adhezion Biomedical Gets FDA Nod for Catheter Adhesive
Adhezion Biomedical won 510(k) clearance for its SecurePortIV catheter adhesive.
The SecurePortIV forms a film that holds catheters to the skin to reduce movement, migration and dislodgment.