FDA Grants Clearance to Outset Medical's TabloCart Featuring Prefiltration

Tuesday, May 07, 2024

Outset Medical, has announced the FDA's clearance of TabloCartTM with prefiltration, an innovative accessory for the Tablo® Hemodialysis System. This clearance allows Outset to resume distribution of TabloCart with prefiltration in the United States.

Outset Medical, emphasized the significance of this FDA clearance, stating, "With the clearance of TabloCart with prefiltration, we have introduced features that enhance the flexibility of the Tablo Hemodialysis System for nurses and healthcare systems, enabling better patient care from the ICU to bedside.

This reaffirms Outset Medical's commitment to innovation and our mission to revolutionize dialysis treatment."

TabloCart is designed to improve the user experience within healthcare facilities, offering two versions tailored to meet diverse clinical needs. Key features include:

  1. Versatile prefiltration: TabloCart offers three customizable prefiltration options to accommodate varying water conditions, alongside a booster pump to enhance incoming water pressure.
  2. Enhanced maneuverability: Equipped with 360-degree rotating wheels and directional locking rear wheels, TabloCart ensures smooth movement in different clinical environments.

TabloCart serves as an optional accessory that complements the Tablo Hemodialysis System, representing a significant advancement in dialysis technology. Tablo, designed for use from hospitals to homes, simplifies the dialysis experience for patients and providers alike.

Utilizing only tap water and a standard electrical outlet, Tablo serves as a comprehensive solution for dialysis delivery across various care settings, enabling flexible and accessible treatment options.


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