Brief: Outset Medical Announces Shipment Hold On New Tablo Systems For Home Use Pending FDA Review And Clearance Of Recent 510(K) Submission

Outset Medical

13/06/2022 21:57

Outset Medical Inc  OM.O :
    * OUTSET MEDICAL ANNOUNCES SHIPMENT HOLD ON NEW TABLO
SYSTEMS FOR
HOME USE PENDING FDA REVIEW AND CLEARANCE OF RECENT 510(K)
SUBMISSION
    * OUTSET MEDICAL INC - OUTSET HAS NOT IDENTIFIED ANY SAFETY
ISSUES
WITH TABLO
    * OUTSET MEDICAL INC - COMPANY WILL CONTINUE TO MARKET AND
SHIP
TABLO FOR USE BY HEALTHCARE PROFESSIONALS IN CHRONIC AND ACUTE
CARE SETTINGS
    * OUTSET MEDICAL INC - DEVICES THAT ARE ALREADY DISTRIBUTED
TO
HOME USERS HAVE NOT BEEN REMOVED
    * OUTSET MEDICAL INC - AS A RESULT OF SHIPMENT HOLD, OUTSET
NOW
EXPECTS Q2 2022 REVENUE OF AT LEAST $25 MILLION
    * OUTSET MEDICAL INC - COMPANY ANTICIPATES AN UPDATE ON
STATUS OF
REGULATORY REVIEW PROCESS IN Q3
    * OUTSET MEDICAL INC - COMPANY HAS SUSPENDED ITS PRIOR
GUIDANCE.

Source text for Eikon:  ID:nBw6WG56Ga 
Further company coverage:  OM.O