But revenue delayed isn't nearly as bad as revenue lost altogether. ![]() Assuming that all goes well, Outset's revenue should be disrupted for only a few months. There's no reason at this point to expect that the company will run into any problems winning a thumbs-up from the FDA for its latest regulatory filing. Outset made changes to its previously submitted 510(k). The FDA requires that a new 510(k) be submitted anytime "there is a change or modification to a legally marketed device and that change could significantly affect its safety or effectiveness." The company initially received FDA clearance for its Tablo dialysis system to be used by home patients in March 2020. A 510(k) application is required to demonstrate that a medical device is safe and effective prior to being marketed. Outset Medical stated in a press release that it suspended shipments of its Tablo system for home use because it's waiting on the Food and Drug Administration (FDA) to review and clear a 510(k) application. But is Outset a buy on the sell-off? Why shipments are being suspended The healthcare stock plunged more than 30% on Tuesday following the news. Outset announced after the market closed on Monday that it was placing a hold on all shipments of its Tablo system for home use. ![]() ![]() That momentum just hit a major bump in the road, though. The company shipped a record number of its Tablo systems for home patients in the first quarter of 2022. Outset Medical ( OM 0.29%) seemed to be at an important inflection point in the home dialysis market.
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