Outset Medical (NASDAQ: OM) seemed to be at an important inflection point in the home dialysis market. The company shipped a record number of its Tablo systems for home patients in the first quarter of 2022.
That momentum just hit a major bump in the road, though. Outset announced after the market closed on Monday that it was placing a hold on all shipments of its Tablo system for home use. The healthcare stock plunged more than 30% on Tuesday following the news. But is Outset a buy on the sell-off?
Outset Medical stated in a press release that it suspended shipments of its Tablo system for home use because it's waiting on the Food and Drug Administration (FDA) to review and clear a 510(k) application. A 510(k) application is required to demonstrate that a medical device is safe and effective prior to being marketed.
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Outset Medical Plunges on Shipment Hold: Buy the Stock on the Sell-Off?