Monidor reach­es major mile­stone as Monidor Vitals gains MDR class IIb CE approval for home health­care use

Monidor Vitals has received its updat­ed MDR Class IIb CE cer­ti­fi­ca­tion, extend­ing its approved use from in-hos­pi­tal envi­ron­ments to home health­care. The cer­ti­fi­ca­tion marks a sig­nif­i­cant mile­stone for the com­pa­ny, as Class IIb approval for home use remains rare with­in the med­ical device indus­try.

With this update, Monidor Vitals is now cer­ti­fied for hos­pi­tal-grade remote mon­i­tor­ing both in clin­i­cal set­tings and in hos­pi­tal-at-home mod­els. In addi­tion, the updat­ed ver­sion intro­duces sig­nif­i­cant­ly more flex­i­ble alarm con­fig­u­ra­tion based on user feed­back. User units can now, for exam­ple, define ward-spe­cif­ic default alarm lim­its and alarm delays, as well as select which devices receive alarms, improv­ing usabil­i­ty and work­flow effi­cien­cy in dif­fer­ent care set­tings.

The plat­form deliv­ers wire­less pulse oxime­try, includ­ing con­tin­u­ous mon­i­tor­ing of SpO₂, pulse, and pho­to­plethys­mog­ra­phy (PPG). The solu­tion sup­ports use cas­es such as pul­monary mon­i­tor­ing in hos­pi­tals and hos­pi­tal-at-home set­tings.

“The Monidor Vitals plat­form is now sol­id, scal­able, and ready for growth,” says Mikko Savola, CEO of Monidor Oy. “Pulse oxime­try rep­re­sents the first step in Monidor’s long-term plat­form strat­e­gy. Build­ing on this foun­da­tion, Monidor Vitals will evolve into a mul­ti-para­me­ter wire­less mon­i­tor­ing plat­form through the inte­gra­tion of addi­tion­al high-qual­i­ty sen­sors in col­lab­o­ra­tion with select­ed part­ners.”

Monidor Vitals is a CE-marked med­ical device under the EU Med­ical Device Reg­u­la­tion (MDR).

Con­tact per­son

Mikko Savola

CEO, Monidor Oy

mikko.savola@monidor.com

Source: Monidor