Allied Healthcare Group (ASX: AHZ) submitted its 510(k) application for FDA clearance of its CardioCel device, a tissue patch designed to repair heart deformities and malfunctioning valves.
The Australian medical device maker has the green-light in Australia for this product and is waiting to hear back about European CE Mark approval. The company is touting recent study data that shows no tissue calcification 4 years after the device is implanted.