Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA.
The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software updates, respectively.
The first feature, according to a beta version preview shared by the company, used artificial intelligence to help the user correctly capture an ultrasound image of the patient's heart, and, with that, automatically computed an ejection fraction measurement.
According to a white paper previously released by the company, the second feature "can provide accurate and reliable bladder volume measurements in [less than six] seconds, regardless of your setting – hospital, urology practice or nursing home." Bladder-volume measurements are used to prevent urinary-retention complications and unnecessary catheterizations that could lead to urinary tract infections, the company wrote in the document.
Butterfly Network told the FDA that it alerted its users of the rescinded features on February 24 via email, and has removed references to the tools from its outward marketing platforms.
Dr. John Martin, Chief Medical Officer at Butterfly Network, described the feature removal as temporary, and said that the company is "working in close collaboration with the FDA" as it works to re-release the two tools.
"This is not a question of the accuracy or quality of the features, but is simply to ensure alignment with the FDA and adherence to the necessary requirements for certain device modifications," Martin told MobiHealthNews in an email statement. "We are working to get both features reactivated, and are confident this will be accomplished soon."
WHY IT MATTERS
The Butterfly iQ made a splash by offering a convenient and cost-effective means for frontline providers to conduct ultrasound imaging. Both of the removed features doubled down on these strengths, using AI to reduce the burden on care providers and assist with clinical decision-making at no additional cost for those already using the system.
Butterfly's revoking of its tools, due to the requirement for additional 510(k)s with each new software feature, is also a demonstration of the FDA's current software-regulation policies in action. The past couple of years have seen the agency weighing new approaches toward software products – whether to reduce the need for trusted vendors to clear each new update via the experimental Precertification Program, or to clear up confusion on which clinical-decision-support (CDS) software would or would not require direct regulatory oversight via draft guidance released last September.
THE LARGER TREND
Since receiving clearance for the device in late 2017, Butterfly has pushed its platform forward by adding a suite of mobile-friendly tools designed to streamline the workflow of frontline providers. The company also made headlines last summer, when the University of California at Irvine Medical School gifted each of its incoming students with their own Butterfly iQ device.
Butterfly is by no means the first digital health company to revoke a software feature to ensure regulatory compliance. Nokia, for instance, made the decision to pull a pulse wave velocity measurement feature from its smart scale in 2018, after learning that the tool would likely require a more stringent level of regulatory approval. Health apps have also been grappling with the challenge of software-only recalls for some time. A recent example is the Roche Accu-Chek Connect diabetes-management app's half-dozen lifetime device recalls.
