Get 40% Off
⚠ Earnings Alert! Which stocks are poised to surge?
See the stocks on our ProPicks radar. These strategies gained 19.7% year-to-date.
Unlock full list

Outset Medical Shares Plunge 21% on FDA Shipment Hold of New Tablo Systems for Home Use

Published 06/13/2022, 01:39 PM
Updated 06/13/2022, 05:43 PM
© Reuters.  Outset Medical (OM) Shares Plunge 21% on FDA Shipment Hold of New Tablo Systems for Home Use

By Davit Kirakosyan

Outset Medical Inc (NASDAQ:OM) shares plummeted more than 21% after-hours Monday following the company’s announcement, according to which it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA’s review and clearance of recent 510(k) submission.

The company now expects Q2/22 revenue of at least $25 million due to the shipment hold. An update on the status of the regulatory review process is expected in Q3. The company will provide an update on its 2022 revenue and other financial goals during its next quarterly update in early August. Until then, it has suspended its prior guidance.

The company has not identified any safety issues with Tablo and will continue to market and ship it for use by healthcare professionals in chronic and acute care settings. Already distributed devices to home users have not been removed and current users can continue to work with their healthcare providers on appropriate treatment.

Latest comments

wery wery nice
Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.