Outset Medical (NASDAQ:OM) lost ~12% on Monday after the MedTech company disclosed that the FDA sent it a Warning Letter citing two additional issues related to its Tablo Hemodialysis System.
In one of the observations, the FDA said that Outset Medical (OM) requires prior 510(k) clearance for marketing authorization of TabloCart with Prefiltration, an accessory to the Tablo System launched in Q3 2022.
Outset Medical’s (OM) plans to resolve that observation include a potential submission of a 510(k) on TabloCart in the U.S.
The other observation relates to the alleged promotion of Tablo for continuous renal replacement therapy (CRRT) for which Tablo is not cleared in the U.S.
The company said that the issue has already been addressed through modifications to labeling and ongoing changes to promotional activities.
OMI has FDA clearance to market the Tablo system for patients with acute and/or chronic renal failure in an acute or chronic care facility.
In issuing a Form FDA-483 in Q1 2023, the regulator had previously cited four observations related to Tablo following its first quality inspection of the company’s San Jose, California, facility.
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Outset Medical stock falls on FDA warning letter (NASDAQ:OM)
