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FDA clears Medtronic RespArray patient monitor for procedural sedation and medical-surgical units – Mass Device

The Medical Device Business Journal — Medical Device News & Articles | MassDevice
September 7, 2022 By
Fridley, Minnesota-based Medtronic designed RespArray for procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography.
RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Algorithms help to detect respiratory compromise early and reduce alarm fatigue.
Medtronic said in a news release that it plans for a limited market release in the fourth quarter of 2022. A full-market release is earmarked for early 2023.
The company said the system helps with the increased need for attention for patients in procedural sedation and medical-surgical units as staffing shortages and clinician burnout caused a decrease in patient safety.
According to Medtronic, improved continuous monitoring and response help to prevent 97% of post-operative opioid-induced respiratory depression. RespArray also connects and integrates into hospital EMRs to improve workflow.
“Helping to keep patients safe is our top priority,” Frank Chan, president of Medtronic’s patient monitoring business, said in a news release. “We engineered RespArray to expand access in procedural sedation and medical-surgical units to critical monitoring technologies that are always watching out for patients. These technologies can help clinicians detect respiratory compromise early so they can intervene fast.”
Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Hospital Care, Patient Monitoring, Regulatory/Compliance, Respiratory
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