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- Andrew Celentano

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

GRAND RAPIDS, Mich., Sept. 10, 2026 /PRNewswire/ — Shoulder Innovations, Inc. (“Shoulder Innovations”, or “the company”) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the N-22 Humeral Head, a titanium implant option for patients with metal hypersensitivity. Alongside the clearance, the company also announced the product’s full commercial launch.

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AI-designed proteins outperform existing CAR T designs against BCMA tumors in mice

CAR T cell therapy, which involves genetically modifying a patient’s own immune cells to fight cancer, is a technique that has shown great promise, especially against blood cancers. But currently, only about 4% of patients with advanced or metastatic cancer in the United States are candidates for CAR T therapy, and closer to 3% will actually benefit, according to one recent analysis.

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