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FDA Grants 501K Clearance to Bladder EpiCheck for Surveillance in NMIBC

The FDA has granted 510K clearance to Bladder EpiCheck for use as a noninvasive method for surveillance of tumor recurrence in previously diagnosed patients with non–muscle invasive bladder cancer, in conjunction with cystoscopy. ....

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Hip replacement pre-op software earns FDA clearance

Joint replacement technology company Formus Labs has earned 510(k) clearance from the FDA for its image processing software for hip replacement preoperative planning. ....

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