Outset Medical Gets Investor Suit Over Device Approval Trimmed

Outset Medical Inc. investors can’t proceed with securities fraud claims over most of the company’s statements about its dialysis machine business that the lawsuit targeted as misleading, a federal court ruled.

But three statements are actionable, Judge Edward J. Davila said Monday for the US District Court for the Northern District of California. Two of them allegedly describe Outset’s TabloCart product, which is a water-filtering adjunct to a dialysis machine called the Tablo Hemodialysis System, as a “non-medical accessory"—that is, a product that didn’t need US Food and Drug Administration clearance. The third statement that can proceed as a basis ...