Philips scores FDA 510(k) for acute patient monitors

The IntelliVue MX750 and MX850 patient monitors received an EUA last year and a European CE mark in 2019.

Dutch health tech giant Royal Philips has scored FDA 510(k) clearance for its IntelliVue MX750 and MX850 patient monitors.

The monitors, which received an FDA emergency use authorization in 2020 and were cleared in Europe with a CE mark in 2019, are designed to support clinical decisions, manage a patient’s condition and needs, and improve infection control within a hospital setting.


Philips is pitching the MX750 and MX850 as their most advanced monitors, including integration with other Philips’ tech and giving providers the option to customize the monitors to their care setting, even in a virtual space.

The company also touts the ability for data to flow into Philips’ acute care telehealth solution and into a hospital’s EHR.

“Continuous patient monitoring plays a vital role in overall patient safety while providing clinicians and caregivers with the holistic view they need to best support their patients and manage their workload,” Sandra Lesenfants, general manager of hospital patient monitoring at Philips, said in a statement.

“Philips Patient Monitors IntelliVue MX750 and MX850 are our most advanced patient monitors and a key part of our modular portfolio of hardware, software, services and consumables that can be tailored to provide integrated monitoring solutions that meet the individual needs of each healthcare provider.”


This isn’t Philips’ only FDA clearance this year. Last month, it scored another 510(k) for its Liver Fat Quantification tool, which helps clinicians diagnose early-stage fatty liver disease.

The company also announced plans to acquire Cardiologs, which recently landed its own FDA clearance to use its AI-backed cardiac diagnostic platform on children and teens.

In October, Philips launched a new digital pathology platform called IntelliSite, and over the summer it announced two new tools in its HealthSuite: a patient flow tool and its acute telehealth product.

“If we think about what are key themes that we do support, and we want to kind of double down on it, one is the collaboration need around care has been truly stepping up,” Roy Jakobs, chief business leader for connected care at Philips, told MobiHealthNews at the time of the HealthSuite announcement.

“And COVID accelerated, of course, the need for that in an unprecedented way, where it exposed the system in terms of where the collaboration was lacking, [and] what the impact was of that, both in terms of the patient impact, as well as the resource-management impact.”

Original Article: (