Dive Brief:
- Medtronic has received Food and Drug Administration clearance for an updated version of its Nellcor pulse oximetry system.
- The 510(k) clearance, which Medtronic disclosed Monday, covers a device with a new processor designed to support more consistent and reliable results across diverse skin tones.
- Concerns about the accuracy of pulse oximeters in people with darker skin pigmentation led the FDA to publish draft guidance on the devices last year.
Dive Insight:
In January, Medtronic published the results of a verification study of its new processor. Used across the full range of skin tones, the technology, Nell-EQ, achieved better oxygen saturation accuracy than the bar set in the FDA’s draft guidance. The FDA granted its Safer Technologies Program designation to the device last year, reflecting the potential for the technology to improve on the safety of existing products.
Nell-EQ incorporates patient- and sensor-specific signal characteristics to more consistently and reliably translate optical signals into blood oxygen results, Medtronic said. The company designed the processor to support accuracy across diverse patient populations, skin tones and clinical care settings.
Receiving FDA clearance for Nellcor with Nell-EQ could help Medtronic as it competes with Masimo for the pulse oximetry market. Masimo, which reported revenue of $1.5 billion last year, has said Medtronic holds “a substantial share” of the market. Danaher agreed to buy Masimo for $9.9 billion in February.
Medtronic reported mid-teens growth in Nellcor sales in its most recent quarterly results earlier this month. Partnerships form part of the Nellcor business, with Medtronic recently extending agreements to integrate the technology into patient monitoring products sold by GE HealthCare and Mindray.
Medtronic plans to make Nellcor with Nell-EQ available globally in the coming months, offering clinician education and training resources to support the rollout. The skin tone issues identified by the FDA are a global concern, which the International Organization for Standardization addressed recently in a revised standard on pulse oximeters.
