US FDA approvals

Connected nebulizer receives FDA approval

AireHealth received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its connected nebulizer. The portable, electronic vibrating mesh device nebulizes liquid medications for a patient to use in and out of the home. This year, the nebulizer will seamlessly connect to VitalCompanion, AireHealth’s new diary companion app that helps patients track symptoms, receive support for medication adherence, and enable real-time connections to providers. AireHealth will also add VitalCapacity, a connected spirometer, to its VitalBreath respiratory care platform.

FDA clearance for Vantage Ankle PSI

The U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for 3D Systems’ Vantage Ankle PSI patient-specific total ankle surgical planning and 3D-printed instruments. The product includes pre-surgical planning and a patient-specific 3D-printed instrument set that guides resections in the tibia and talus for total ankle replacement surgery using Exactech’s Vantage Total Ankle System. Vantage Ankle PSI increases operating room efficiency, reliability, and improves soft-tissue preservation around the joint. This advancement is a result of the collaboration between 3D Systems and Exactech, developer and producer of innovative implants, instrumentation, and computer-assisted technologies for joint replacement surgery.

“Through our collaboration with Exactech, we drew upon our collective expertise in orthopedics to develop an end-to-end solution for total ankle replacements that is unique to the market,” says Menno Ellis, EVP, healthcare solutions, 3D Systems.

“Our collaboration with 3D Systems represents a meaningful advancement that will accelerate the success of our Vantage Ankle prosthesis,” says Exactech CEO Darin Johnson.

3D Systems and Exactech have entered into a distribution agreement for the Vantage Ankle PSI product offered exclusively with Exactech’s Vantage Total Ankle System. https://www.3dsystems.com; https://www.exac.com