FDA's decision puts Outset Medical back on hyper growth track

With the recent quarterly results, Outset Medical also announced that the FDA cleared its dialysis device Tablo for use at home after two months of suspension. The company's business at home, its main market opportunity, is finally getting back on track.

Bottom line

Only 2 months after the FDA temporarily suspended Outset’s flagship product (Tablo for patients at home) asking for more data, the regulatory agency reversed its decision. Although the halt compounds macro headwinds and impacts the company’s growth story in the near term, Outset is addressing again a $9bn market opportunity with long-term favorable drivers and solid fundamentals, that will restore its appealing commercial momentum.

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