Capsule Technologies, a medical device-maker (not to be confused with digital pharmacy Capsule), has just landed FDA 510(k) clearance for its new connected capnography-monitoring technology.
Called Vitals Plus monitoring solution, it was created to incorporate Masimo’s NomoLine ISA CO2, and designed to keep track of a patient’s end-tidal carbon dioxide, respiratory rate, and fractional inspired CO2. The company is pitching the technology as a way to keep track of a patient’s ventilation adequacy and changes in a patient’s cardio and respiratory conditions.
The data from the monitors can be sent directly to the EHR. The tech can be integrated with Capsule’s Early Warning Scoring System (EWSS) in order to alert care teams if a patient is deteriorating.
WHY IT MATTERS
The company said that these measurements are key to accessing hypoventilation and hyperventilation after respiratory depression or arrest. It can also be used to help check for spontaneous circulation after a heart attack.
“The ability to continuously monitor CO2 levels keeps patients safer by identifying deterioration faster than other methods,” said Hemant Goel, CEO of Capsule. “Our partnership with Masimo gives clinicians a convenient way to add this important measurement for immediate use and automatically add the measurement data to the patient record with other patient vital signs. This FDA 510(k) clearance also helps expand Vitals Plus into more low- and mid-acuity care settings, including more opportunities to help hospitals monitor patients receiving opioids, which is an increasingly important application for capnography.”
THE LARGER TREND
Connected medical devices have been on the rise for the last decade. Capsule is over 20 years old and has been consistently working in that space. During the coronavirus Kevin Phillips, VP of product management at Capsule, told MobiHealthNews that the company supported connected ventilators.
“So we have a surveillance solution that gives critical experienced care clinicians visibility on those ventilated patients and identifies emerging clinically actionable events so that we can reduce the time that clinicians have to go into the patient rooms,” Philips said.
While the connected medical devices is growing in popularity the FDA has been rolling out guidance about the tools. In 2018 the agency unveiled its Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which is codeveloped with Mitre Corporation.
Original Article: (https://www.mobihealthnews.com/news/capsule-technologies-earns-fda-green-light-capnography-monitor#:)