Abbott Adds MRI-Compatibility to Ellipse Defibrillator
The FDA approved conditional labeling of magnetic resonance for Abbott’s Ellipse implantable cardioverter defibrillator. The addition allows patients with the implants to undergo MRI scans.
Ellipse monitors heart rhythms and can deliver a shock to a patient’s heart. The data captured by the device and wirelessly transferred allows for remote monitoring to help the patient’s care provider determine whether intervention is needed.
FDA Clears Brainlabs’ Radiosurgey Software Apps
Two software applications from device manufacturer Brainlab, Elements Spine SRS and Elements Cranial SRS, were cleared for marketing by the FDA. The software helps physicians craft plans for spine and brain radiosurgery treatments.
The Elements Cranial SRS can create a radiosurgery plan for several cranial indications and it uses an integrated algorithm that allows for organs at risk and healthy tissue to be spared from treatment.
The Elements Spine SRS takes into account spine curvature variations to help ensure that radiation doses are delivered to the tumor and not the spinal cord.
Endologix Snags CE Mark for Aneurysm System
Endologix received a CE mark for the Nellix EndoVascular aneurysm sealing system, an abdominal aortic aneurysm therapy that is the only device whose operating principle is centered around sealing the entire aneurysmal sac, according to the company.
The device is currently being studied in the U.S. for endovascular repairs.
Pentax Medical Wins CE Mark for DEC Duodenoscope
Hoya‘s Pentax Medical won CE Mark approval in the European Union for its DEC duodenoscope featuring a disposable elevator cup.
The device has advanced cleaning capabilities, high definition video quality and improved infection prevention controls.
The single-use, sterile, distal end cap was designed to reduce the likelihood of carbapenem-resistant Enterobacteriaceae infections which have been linked to duodenoscope devices.
Siemens Healthineers Receives CE Mark for Atellica Advanced Diagnostics System
Siemens Healthineers won a CE Mark for its Atellica Solution advanced diagnostic system. The system consists of scalable immunoassay and chemistry analyzers, and can run up to 440 tests per hour. It includes 170 assays and a 10-minute turnaround for certain cardiac, reproductive and thyroid tests.
The system is now available in Europe, the U.S., South America and Asia.
LivaNova Wins 510(k) Clearance for Optiflow Arterial Cannulae
LivaNova won 510(k) marketing clearance for its family of Optiflow Arterial Cannula.
The device has a “basket tip with large openings” to significantly reduce wall shear stress and turbulence.
The device provides improved hydrodynamics and includes a dispersive tip that boosts blood flow.