2023-07-10 10:03:49 ET
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.
Regarding the other observation that relates to the alleged promotion of Tablo for continuous renal replacement therapy (CRRT), the company said that the issue has already been addressed through modifications to labeling and ongoing changes to promotional activities.
OMI, a maker of hemodialysis systems, has FDA clearance to use the Tablo system in patients with acute and/or chronic renal failure in an acute or chronic care facility. However, its approval doesn’t extend to CRRT, a subtype of hemodialysis.
In issuing a Form FDA-483 in Q1 2023, the agency had previously cited four observations following the first quality system inspection of the company’s San Jose, California, facility.
For further details see:
Outset Medical falls after FDA warning letter