Outset Medical, Inc. (NASDAQ:OM) shares are trading higher Monday after the company announced that TabloCart with prefiltration received FDA clearance.

The Details:

Outset said that it has resumed distribution of TabloCart with prefiltration and has product available to ship to customers in the United States.

"With the FDA's clearance of TabloCart with prefiltration, we have delivered features to the Tablo Hemodialysis System that increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside," said Leslie Trigg, CEO of Outset Medical. "Today's announcement underscores Outset Medical's commitment to innovation and our ongoing dedication to transforming the landscape of dialysis treatment."

Outset Medical shares are moving on heavy trading volume following the announcement. According to data from Benzinga Pro, more than 14.13 million shares have been traded in the session, compared to the stock's 100-day average of less than 969,000 shares.

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OM Price Action: According to Benzinga Pro, Outset Medical shares are up 27.7% at $4.01 at the time of publication Monday.

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