Arterys announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arterys Software. This clearance allows the Arterys product to be used in clinical settings for the quantification of cardiac flow, which includes 4D flow and 2D Phase Contrast workflows, and cardiac function measurements. The product seamlessly integrates into clinical practice to provide comprehensive, simple and quick Cardiac MR imaging. Previously, the Arterys Software received FDA clearance for its 4D Flow visualization feature.
AtriCure, Inc. announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its cryoICE™ platform and CRYO2 cryoablation probe. The approval marks the first time that these products will be available in the Japanese market.
“We are pleased to have this approval in hand, and to be able to bring our cryoablation products to the Japanese market,” said Mike Carrel, President and CEO of AtriCure. “This new approval will augment our offerings in the Japanese market and offer a leading solution to cardiac surgeons and the Japanese patients for the treatment of Afib.”
The company’s distributor in Japan, Century Medical Inc. (CMI), worked closely with AtriCure to secure approval. Product will be immediately available for sale as soon as the reimbursement application is completed, which is expected in the fourth quarter.
“Japanese surgeons have been waiting a long time for this moment. We believe many patients will benefit from this technology and look forward to bringing it to market,” said Takahiko Motani, president and CEO of CMI.