> Back to Nellcor Fiction Home

NELLCOR FICTION:

"The Nellcor N-600 and N-600x perform as well as or better than their earlier generation products found to infringe on Masimo patents."

FACTS:

  • After losing the patent lawsuit Nellcor faced an imminent injunction on the N-395 and N-595.
  • With the discontinuance of the products found to infringe, Nellcor announced a new product, known as the N-600, which was not subject to the litigation. Nellcor did not include adaptive filters or parallel algorithms to measure saturation in this product, which remain significant contributors to the unparalleled performance of Masimo SET and Masimo Rainbow SET oximeters.
  • Although Masimo believed the N-600 design still infringed some of Masimo's patents, after testing the N-600 oximeter provided to Masimo by Nellcor, Masimo agreed to provide a covenant not to sue Nellcor on the N-600 platform in exchange for an on-going royalty. However, if Nellcor improves the performance of the N-600, the improved product may not be covered by the covenant not to sue.
  • Nellcor changed its FDA indications and directions for use for the N-600 and N-600x:
    • FDA indications and directions for the N-595 stated the device was intended for use "during both motion and no motion conditions." For the new N-600 and N-600x devices, the intended use statement does not include these indications for use.
    • While the N-395 and N-595 manuals make no mention of it, Nellcor's N-600x manual states the N-600x utilizes up to 50 seconds of "averaging" for pulse rate and 40 seconds of "averaging" for SpO2 during motion.
    • Nellcor recently introduced the N-600x, but Nellcor's own website says: "The OxiMax N-600x pulse oximeter has the same signal processing technology as the OxiMax N-600 pulse oximeter."
  • Independent studies show Nellcor products produced after the settlement perform worse than their previous products.
  • The superiority of Masimo SET vs. the Nellcor N-600/N-600x is observable in a side-by-side demonstration and clinical evaluations.

PROOF: