On July 1, Artivion received FDA approval for its AMDS Hybrid Prosthesis, removing a key hospital adoption hurdle and opening an estimated $150 million annual U.S. market. On July 2, Tenon Medical received FDA 510(k) clearance for its updated Catamaran SI Joint Fusion System, which includes the reclassification of certain instruments from disposable to reusable status. The company expects reusable instrumentation to drive lower capex and improve gross margins and cash flow. On the same day, Avanos Medical and American Industrial Partners announced the receipt of all required regulatory approvals to complete the pending acquisition.
