Ultrasound systems receive FDA clearance

Philips announced that two CV ultrasound systems to perform diagnostic, pediatric and interventional echocardiography have received 510(k) clearance from the FDA.

One system (Epiq CVx) aids clinicians by simplifying workflow and increasing diagnostic confidence with improved image quality, according to a press release from the company.

“The Epiq CVx brings together advanced image quality, quantification and intelligence specifically for the cardiologist,” Roberto Lang, MD, professor of medicine and director of the noninvasive cardiac imaging laboratory at University of Chicago Medicine, said in the press release.

The system also features image sharpness, higher processing power and reproducible quantification through anatomical intelligence. It includes technology (TrueVue) to provide clinicians with photorealistic rendering of the heart. An OLED monitor allows side-by-side image comparisons.

Anatomical intelligence is also utilized in a feature to quantify left ventricle function (Dynamic heart model, Philips), which reduces the time needed to generate a 3D ejection fraction.

Another system (Epiq CVxi) has been created specifically for the interventional lab and includes a tool (EchoNavigator) to improve communication between the interventional cardiologist and echocardiographer. This system also combined live ultrasound and X-ray into one view.

“With the Epiq CVx and its cardiology-centric design, clinicians can perform fast exams with enhanced diagnostic information,” David Handler, general manager of cardiac ultrasound at Philips, said in the press release. “The Epiq CVxi is our third-generation integrated ultrasound-angiography cath lab solution for real-time, workflow-optimized image guidance and advanced quantification for structural heart procedures.” - by Darlene Dobowski

Disclosures: Handler is an employee of Philips. Please see the study for all other authors' relevant financial disclosures.