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Butterfly Network told the FDA that it alerted its users of the rescinded features on February 24 via email, and has removed references to the tools from its outward marketing platforms.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.

This morning MassChallenge hosted a virtual summit focused on innovation in the time of the coronavirus. This comes amid the growing number of coronavirus cases in the United States. As of today the World Health Organization reported over 42,000 cases in the U.S. alone.

This rising number has resulted in a slew of innovations to address some of the most pressing questions, including testing, treating and tracking the disease. But, like many other industries, startups are still learning about the need.

Nick Doughty, managing director of MassChallenge HealthTech, posed the question of what innovators need to know about how the government and public health officials are addressing this virus, to a panelist of insiders. Viewers got some good, and bad news from the speakers.

"I do have some good news, which is that there is nothing about this virus or outbreak that can't be tackled with our traditional public health playbook," Margaret Bourdeaux, research director at Harvard Medical School, said during the panel discussion. "So that's great. We know what to do and what the plan has to be, but executing on that is going to require a lot of American camaraderie and ingenuity."

Bourdeaux noted that other countries who have had success flatting the curve have followed four main steps. The first is identifying cases, which will take massive testing efforts. Thus far, testing efforts have posed a challenge for the country. According to a report by Oxford University's Our World in Data, the per capita number of tests in the U.S. is 40 times lower than that in South Korea.

Last week a slew of take-home testing kits were scheduled to be launched, however the majority of these of offerings have since been rescinded, or hang in doubt, thanks to new warnings and regulatory clarifications issued this weekend by the FDA. It is important to note these are not the only testing efforts. Several industry players, such as Roche, are also creating new tests.

Second, Bourdeaux said successful countries have strengthened their abilities to implement contact tracing, meaning pinpointing which individuals have been exposed to a person with the virus.

Third, countries have to be able to support safely isolating patients who have been infected with the disease. But this will take what she calls some TLC, which could come in the form of digital tools.

"It's extremely difficult to be isolated, sick and not be able to be supported," she said. "I think what we have learned from other outbreaks is ... how to be with people without physically touching them."

Fourth, countries who have been able to get control of the virus have been able to support quarantine for those who have been exposed to the virus, but are not sick.

"We can do all those things, those things have been done [before] in the United States ... It does require innovation," she said. "Until that framework has come together, we do have to lean in on physical distancing, because that is the only thing we can do to break transmission. Once we start rolling out testing, contract tracing, safe and supportive isolation, and quarantine, we can start to relax those measures, and right now it's up to us. My only concern is not aligning policy and executing on the plan, then I'm worried."

While the world is currently quarantining, it's important to remember the well-being of those at home, particularly the senior population, said Charlotte Yeh, chief medical officer at AARP.

"I don't want to forget about the person who is isolated and lonely, who is not connected. Think about easy plug-and-play if relying on voice technology and telephone calls," Yeh said. "Think about the hearing impaired, that is, two-thirds of everybody 70 and older. Are you thinking about captioning? What can you do with Bluetooth? What are you doing to test the hearing and making sure they can communicate clearly? This is a great opportunity for the innovators out there, so I think we have real positivity that can come out of this."

Across sectors there is unity on what needs to be done, said Juliette Kayyem, cofounder and CEO of Grip Mobility and a national security analyst for CNN. However, in the U.S. there is a lot of variation in quarantine requirements between states and even cities. She noted that this means the private sector has to be responsible for their employees.

"None of it gets done with a hodgepodge social isolation standard. We are the only country besides Brazil now without a strong national focus on a stay-at-home campaign ... so in the absence of that we look to other leadership," Kayyem said. "We saw it with governors and mayors. You saw it with CEOs. Twitter did it immediately. My advice to everyone here – everyone is a president – your capacity to control or set standards for good behavior for employees, and serve as a model for your conduct, and ability to help in a system that is not being unified."

While there may not be a central strategy for the entire U.S., Kayyem said that the private sector is busy organizing, and there are sources for startups to look up ways to help.

"There has been really good NGO and private-sector organization," she said. "There is a website called COVID-19 Action Tracker. It gives a list by state of how you can contribute resources, personnel, expertise and data management. Good news is the plan is sound and agreed upon by everyone who knows the field."