Masimo Receives FDA Approval for Continuous RRp Monitoring

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Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) monitoring with its with Rad-97, Radical-7, and Radius-7 Pulse Co-Oximeters.

Usually, monitoring respiration rate involves manually
counting breaths with a timer or using chest straps that need to be fitted. The
newly-approved Masimo RRp monitor allows clinicians to conveniently measure
respiration rate in patients whose arterial oxygen saturation is already being
monitored using the Masimo SETpulse oximetry monitor.

Respiration rate is an important vital sign because breathing difficulty is considered one of the earliest signs of clinical deterioration. Masimo hopes that the RRp will play a role in helping clinicians and public health officials as they treat respiratory-related illnesses, including the coronavirus COVID-19.

Medgadget reported last week that Masimo received FDA clearance for its MightySat Rx, a fingertip pulse oximeter that can spot-check respiration rate in the home or clinic setting.

The approval of Masimo’s continuous RRp monitoring adds to the company’s available respiration rate monitoring modalities, including acoustic respiration rate and NomoLinecapnography. Masimo hopes that this variety will help clinicians ensure they have the right tools for each patient scenario, according to the announcement.

“We aim to provide clinicians with the best monitoring tools so that they can provide the best care possible – which means recognizing that a monitoring method that works particularly well in one patient scenario may not be available or be the best choice in another,” Masimo Founder and CEO Joe Kiani said in the release. “With the introduction of continuous RRp to our devices in the US, we are finally able to give clinicians in our home country a powerful third way to monitor respiration rate continuously, complementing other methods with a convenient and cost-effective single-sensor solution.”

Related product info links: Rad-97; Radical-7; Radius-7

Via: Masimo





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