By Kelly Cloonan
Monogram Technologies has received clearance from the Food and Drug Administration for its mBôs Total Knee Arthroplasty system.
The company said Wednesday the clearance means it can start marketing the device, and is preparing for initial placements with surgeons in select areas of the U.S.
The placements aim to gather real-world clinical evidence and deepen surgeon engagement, the company said.
Monogram also gained regulatory approval from India's Central Drugs Standard Control Organization to import the system and initiate a 102-patient clinical investigation to evaluate its safety and effectiveness.
The company expects patient enrollment to begin shortly, with the first live surgeries in the next 90 business days.
The clearance and regulatory approval provide a clear path to commercial adoption in key markets, Chief Executive Ben Sexson said.
Shares rose 8.8% to $2.72 in after-hours trading Wednesday.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
May 14, 2025 17:17 ET (21:17 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。