Approvals

Globus Scores 510(k) Approval for GPS Guidance System

Globus Medical secured 510(k) approval from the FDA for its GPS robotic guidance and navigation system.

The device, the Excelsius, works with three different imaging technologies to integrate implants and instruments. It is compatible with pre-operative, intra-operative and post-operative CT and fluoroscopic imaging.

The company plans a worldwide launch and is increasing investment in R&D, technology acquisition and distribution channels following the approval.

FDA Clears Dictum Health Portable Spirometry System

Dictum Health received 510(k) approval for the last stage of its IDM100 Medical Tablet.

The last step, spirometry, completes the tablet’s cardiopulmonary capabilities.

The portable device is intended for use with pediatric and adult patients with supervision by healthcare professionals. It has the same accuracy as in-hospital exams, improving outcomes and cutting readmission risk, according to the company.

Creo Gets FDA 510(k) Nod on Speedboat RS2 Device

Creo Medical Group has secured FDA 510(k) clearance for its Speedboat RS2 device and CROMA platform.

The Speedboat RS2, which enables minimally invasive endoscopic removal of cancerous and precancerous lesions, was cleared ahead of schedule, according to the firm.

Creo CEO Craig Gulliford said the early approval gives the company confidence to move forward with the devices it has in development.

Medtronic Gets CE Mark for CRT Leads

Medtronic received a CE Mark for its Attain Stability quad cardiac resynchronization therapy leads.

The leads are MRI safe and designed for CRT defibrillators and pacemakers. They are cleared for use with 1.5T and three Tesla scans. They include a side-helix that can be affixed in veins of several sizes.

Medtronic has begun a limited European launch, with the first commercial implants performed at the Haukeland University Hospital in Bergen, Norway. The company has launched a global clinical study to determine the lead’s safety and effectiveness in heart failure patients.

Bioventrix Scores IDE Nod for Revivent TC

BioVentrix announced the FDA granted it investigational device exemption approval for its Revivent TC transcatheter ventricular enhancement system.

The company has launched a safety and efficacy trial for the system, which is designed to treat ischemic cardiomyopathy. The system eliminates the need for cardiopulmonary bypass or heart incisions, according to BioVentrix.

BioVentrix enrolled the first patient in its trial, with the first procedure performed at Papworth Hospital in the United Kingdom. The company will enroll 120 patients at 20 sites across the U.S. and the UK.