Approvals

Materialise Cardio Planning Software Cleared

The FDA granted Materialise 510(k) clearance for its Mimics Enlight product, a suite of cardiovascular planning software that create 3D models for use in transcatheter mitral valve replacement (TMVR) procedures.

The device provides clinicians with accurate 3D models for consistent patient screening. It also helps clinicians to determine the appropriate size and placement of TMVR devices.

Biocorp Earns CE Mark for Insulin Tracker

Biocorp has gained approval in Europe for the Mallya smart sensor, a device that records key treatment information for diabetic patients.

The sensor connects conventional insulin pens to a mobile app, tracking the selected dose, date and time of injection. The automated recording eliminates the need for logbooks and manual recordkeeping.

The device also creates a summary report of a patient’s injected doses over the previous three months.

Heart Murmur Sensor Gains CE Mark

Austria-based eMurmur has earned the CE Mark for its heart murmur sensor, a mobile device that uses cloud technology in conjunction with a third-party electronic stethoscope.

The device makes use of advanced machine learning to identify pathologic and innocent heart murmurs, as well as the absence of a heart murmur.

The system uses machine learning, a mobile app and a web portal to help healthcare providers with cardiac auscultations.

This usually requires providers to have good hearing and the ability to distinguish different pitches and timing.

CorMatrix Epicardial Patch Cleared

The FDA granted CorMatrix Cardiovascular 510(k) clearance for its Cor PATCH epicardial patch, used to support and repair heart tissue in adults and patients.

The device is able to provide epicardial support and repair of atrial and ventricular walls of the heart that have been reduced or damaged by a heart attack.

Jubilant DraxImage Rubidium Elution System Receives CE Mark

Jubilant DraxImage’s RUBY Rubidium Elution System (RbES) and its accompanying accessories have earned the CE Mark for use in myocardial imaging.

The elution system delivers customized patient doses of rubidium chloride injection, a radioactive diagnostic agent used in PET imaging. The doses are generated using the company’s RUBY-FILL device and require an elution system due to their short half-life.

The radioactive diagnostic agent is indicated for PET imaging of the myocardium under rest or stress conditions to assess regional myocardial perfusion in adult patients that have or may have coronary artery disease.