Outset Medical receives FDA 510(k) clearance for TabloCart with Prefiltration
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Key takeaways:
- The announcement notice comes after Outset paused shipment of the device in August 2023.
- The company announced it has resumed distribution of the device in the United States.
The FDA has granted Outset Medical Inc. 510(k) clearance of TabloCart with Prefiltration, an optional accessory for the Tablo Hemodialysis System, according to a press release.
“With the FDA's clearance of TabloCart with prefiltration, we have delivered features to the Tablo hemodialysis system that increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside,” Leslie Trigg, chair and CEO of Outset Medical, said in the release. This announcement “underscores Outset Medical’s commitment to innovation and our ongoing dedication to transforming the landscape of dialysis treatment.”
The notice comes after Outset paused shipment of the device in August 2023, following a warning letter from the FDA stating that the cart needed clearance for marketing authorization.
Outset stated in a previous release that its 2023 revenue guidance had a range of $144 million to $150 million but in August 2023, it expected to be at the low end due to the shipment pause.
The TabloCart is a single solution device intended to streamline and make dialysis treatment more accessible, according to the release. Its two versions include one with added storage and one with water prefiltration capabilities.
The company announced it has resumed distribution of the TabloCart in the United States.
References:
Outset Medical reports second quarter 2023 financial results. https://investors.outsetmedical.com/news-releases/news-release-details/outset-medical-reports-second-quarter-2023-financial-results. Published Aug. 2, 2023. Accessed May 8, 2024.
Outset Medical's TabloCart with prefiltration receives FDA 510(k) clearance. https://investors.outsetmedical.com/news-releases/news-release-details/outset-medicals-tablocart-prefiltration-receives-fda-510k. Published May 6, 2024. Accessed May 8, 2024.
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