Nasdaq

Outset Medical’s Tablo® Hemodialysis System Receives Landmark TPNIES Approval From CMS

SAN JOSE, Calif.--(BUSINESS WIRE)-- Outset Medical, Inc. (Nasdaq: OM) (“Outset”) today announced that its Tablo® Hemodialysis System has received the first-ever approval from the Centers for Medicare ...
Business Wire

World’s First Patient Starts Using Outset Medical’s Tablo Dialysis System at Home

Outset Medical is dedicated to technology-driven service model innovation aimed at reducing cost and transforming the patient care experience. Outset’s Tablo System is FDA-cleared for use in acute, ...
Business Wire

Outset Medical Announces Shipment Hold on New Tablo Systems for Home Use Pending FDA Review and Clearance of Recent 510(K) Submission

SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, Inc. (Nasdaq: OM) (“Outset” or the “company”) today announced it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System ...
Yahoo Finance

New Research Demonstrates the Advantages of an Insourced Dialysis Service Line for Acute-Care Facilities Using Outset Medical’s Tablo® Hemodialysis System

SAN JOSE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM) ("Outset"), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and ...
Yahoo Finance

Next-Generation Tablo Hemodialysis System Receives FDA Clearance, Second Quarter Launch Planned

SAN JOSE, Calif., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM), a medical technology company pioneering a first-of-its-kind technology to improve clinical outcomes in dialysis ...
Healio

Outset sets record for delivery of Tablo dialysis machines

Please provide your email address to receive an email when new articles are posted on . Outset Medical, maker of the Tablo hemodialysis machine, reported that the device was added to 30 new hospital ...
FierceBiotech

Outset Medical pauses at-home dialysis shipments, sending stock to all-time low

After kicking off the year by shipping out a record number of its Tablo hemodialysis systems for at-home users, Outset Medical has brought those sales to a screeching halt. The California-based ...
Healio

FDA approves Outset Medical’s Tablo dialysis machine for home use

Please provide your email address to receive an email when new articles are posted on . The FDA has approved Outset Medical’s Tablo Hemodialysis System for use in a home setting after positive results ...
Nasdaq

Tablo® Hemodialysis System Cartridge Receives FDA 510(k) Clearance Enabling Production in North America

SAN JOSE, Calif.--(BUSINESS WIRE)-- Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company reducing the cost and complexity of dialysis, announced today that the U.S. Food and Drug ...
Seeking Alpha

Outset Medical outlines 5%–9% revenue growth for 2026 with next-gen Tablo launch and gross margin expansion

Gaeta provided 2026 revenue guidance of "$125 million to $130 million, a 5% to 9% increase over 2025." She expects "the first quarter to be roughly flat to the fourth quarter of 2025, and then ...
The Motley Fool

Outset Medical Plunges on Shipment Hold: Buy the Stock on the Sell-Off?

Outset Medical announced a hold on shipments of its Tablo dialysis system to home users. This hold will be in place until the FDA completes its review of a new regulatory filing. Outset's revenue will ...