OrthAlign’s “Smart” Navigation Device For Total Hip And Total Knee Arthroplasty
OrthAlign has received 510(k) clearance for OrthAlign Plus, a palm-sized “smart” instrument designed to be a reliable and efficient alternative to expensive and bulky computer-assisted surgery systems.
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It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?