FDA OKs Fresenius dialysis software to guide patients, caregivers through at-home sessions

Though the increasing availability of at-home hemodialysis systems represents a convenient alternative to reporting to the clinic several times a week—allowing patients to undergo the blood-cleaning process from the comfort of their own homes—it may be difficult for them to get the hang of managing the procedures themselves without all the resources and trained professionals found in a clinical setting.

That’s where Fresenius Medical Care comes in. The kidney care giant has developed a software program for its own home dialysis systems that’s designed to guide patients and their in-home caregivers step-by-step through the procedure.

The GuideMe software will soon be available to users of Fresenius’ VersiHD dialysis machines across the U.S., as the company announced Wednesday that it’s been newly cleared by the FDA. The rollout will start this year in “selected markets,” per Fresenius, and current VersiHD users will also be able to upgrade to the new software system on their existing devices.

The VersiHD home dialysis machine was first introduced in 2017—the same year its maker NxStage initially agreed to be acquired by Fresenius in a deal valued around $2 billion that didn’t end up closing until 2019. The system is cleared for both solo and overnight use, offers users a simplified setup process and can be easily transported around a patient’s house or beyond.

Fresenius Medical Care GuideMe
(Fresenius Medical Care)

The GuideMe software displays its instructions on the VersiHD devices’ brightly lit, full-color touchscreens. It includes step-by-step guides through the processes of setting up, conducting and ending dialysis treatments, with each guide comprising a checklist of simple actions accompanied by pictures to serve as visual aids.

Ultimately, the guidance is meant to speed up the patient training process and make it easier while also giving users more confidence as they transition from in-clinic to at-home dialysis sessions, according to Fresenius.

“We expect VersiHD with GuideMe Software to further simplify home hemodialysis for patients during training and at home,” Brigitte Schiller, M.D., medical officer of Fresenius’ home therapies business, said in the announcement.

Additionally, according to Schiller, “VersiHD with GuideMe Software will support Fresenius Medical Care’s mission of advancing access to home therapies to more patients.”

Indeed, in recent years, the company has prioritized and celebrated the increase of at-home dialysis patients. After setting a goal of treating at least 15% of patients in the home setting by 2022—which it achieved ahead of schedule in 2021—Fresenius has since bumped up that aim to 25%.

It’s somewhat slow going, however: During a second-quarter earnings call earlier this month, CEO Helen Giza reported that the number of home users was “hovering around the 16% mark.”

“Some of the labor stabilization … is helping that so we can drive trainings again,” Giza continued. “So we’re seeing our training volume up, which will, in turn, obviously translate into a higher home percentage. But we know that we’ve really got to turn the corner on this to get to our 25% goal.”