Healio

FDA questions Outset Medical’s marketing of Tablo dialysis products

Outset Medical Inc. reported in a recent 8-K filing that it had received a warning letter from the FDA expressing concerns about the company’s marketing of its Tablo dialysis machine and other ...
Nasdaq

OM Stock Gains on FDA Clearance for Next-Gen Tablo Dialysis System

Outset Medical, Inc. OM recently announced that its next-generation Tablo hemodialysis system has received 510(k) clearance, marking a key regulatory milestone for the company. The clearance positions ...
Business Wire

Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) Clearance

SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of 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 ...
MD&M East

Did Outset Medical Put the TabloCart Before the Horse?

Dialysis tech company Outset Medical appears to have put the cart before the horse, so to speak. The "cart" in this case being quite literal – the TabloCart – and the "horse" being metaphorical for ...
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 ...