FDA grants 510(k) approval for Ingenia Elition 3.0T MR solution.- Royal Philips.

Royal Philips announced that it has received 510(k) clearance from the FDA for its Ingenia Elition 3.0T MR solution and two clinical applications, Philips Compressed SENSE and 3D APT. This integrated suite of innovations enables clinicians to perform exams up to 50% faster , increase diagnostic confidence and improve the patient experience. The first commercial installation of the Philips Ingenia Elition in the U.S. has recently been completed at Hennepin Healthcare, a comprehensive healthcare system in Minneapolis.

The device was designed to help speed many types of examinations without sacrificing image quality, in certain cases doing so in half the time of competing devices. The system features the firm�s dStream digital broadband tech, as well as Compressed SENSE and 3D APT capabilities that are aimed at helping to perform scans, making them a little more pleasant for patients, and expanding the scope of the Ingenia Elition . The device can see where the patient is located on the table and features SmartExam capability, which is an artificial intelligence-powered platform for planning, scanning, and processing the scans that takes much of the work and challenges out of the operators hands. VitalScreen technology guides the operator in setting up an exam to make sure it�s appropriate, while VitalEye senses the patient and detects breathing without any input from the tech. Using both of the technologies can help get a routine exam started in less than a minute, which can significantly improve the utilization of the scanner. Once inside, Philips Ambient Experience and Connect solution, which make a claustrophobic experience more enjoyable, engages the patient using video and audio. This can help soothe nerves and make patients calm, avoiding poor scans and subsequent rescans.

Comment: This system is available in Europe .