FDA clears Catalyst OrthoSciences’ shoulder system: 5 things to know

Naples, Fla.-based Catalyst OrthoSciences received FDA 501(k) clearance for its Catalyst Fracture Shoulder System, according to an Oct. 15 news release from the company.

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Here are five things to know:

1. The system is a reverse for fracture arthroplasty system to treat proximal humeral fractures.

2. In addition to the FDA approval, the first surgeries using the system have been completed. 

3. The system is designed to improve tuberosity fixation and healing.

4. The company plans for a larger commercial release of the system in 2025. 

5. Catalyst OrthoSciences raised $20 million in financing in September.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

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Wednesday, July 29
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Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

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