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.
Avanos Medical and American Industrial Partners have received all required regulatory approvals, clearing the path to finalize their pending merger agreement.
Read the full storyThe company received 510(k) clearance for its upgraded Catamaran system, reclassifying instruments as reusable to drive operational efficiency.
Artivion received FDA approval for its AMDS Hybrid Prosthesis, removing a key hospital adoption barrier and unlocking an estimated $150 million annual U.S. market.