The FDA has granted 510(k) class II clearance to La Jolla, California-based Sense4Baby's cellular-enabled maternal and fetal monitoring system. The company has also secured a CE Mark for the European market and other countries where that approval is recognized. The regulators cleared Sense4Baby's "model B+" system for healthcare providers to use to monitor expectant mothers and their fetuses during the antepartum period -- meaning not during labor and delivery, but any time before.
Sense4Baby CEO Dr. Jessica Grossman told MobiHealthNews that the first indication for the monitor's use will be for non-stress tests with high-risk pregnancies.
"The clearance was for use by a healthcare practitioner -- so that could be a nurse or a doctor," Grossman said. "The patient is the high-risk pregnant patient, because that is who the non-stress test is designed for. These are patients with high blood pressure, [for example]... or some other chronic disease. The non-stress test is a monitoring session and it is traditionally done in a healthcare setting -- office or hospital. With this approval, a provider can provide this monitoring test wherever cellular networks are found."
Grossman, who is herself an OB/GYN and former medical director of J&J's Ethicon Endo-Surgery company, contends that the mix of vital signs that Sense4Baby's device is able to monitor makes a non-stress test its primary indication, doctors might use it for other reasons, too.
The cleared device is a packaged kit that Sense4Baby puts together and it includes either a dedicated smartphone or tablet with pre-loaded Sense4Baby software, which runs the device. Another piece of software, which Sense4Baby calls the Portal, is web-based and allows the provider to view or review all that data entered through the mobile app as well as the monitoring data.
While the FDA has given the company the greenlight for marketing and commercialization, Grossman said Sense4Baby's rollout strategy will be targeted and begin with a few beta testing sites in the US that are mostly just getting underway. These include user evaluation sites at academic and research centers. That said, Sense4Baby is available and for sale to any providers who are interested.
The company's first commercial deployment was in The Netherlands, where Grossman says there is an advanced system already in place for home health care and Sense4Baby is being used alongside a number of other mobile health technologies. In that country midwives are sent to the homes of high risk pregnant patients to perform the non-stress tests, and Sense4Baby hopes to collect data related to cost savings for these tests, since the women did not have to make a costly trip to the hospital for them.
Healthcare costs are a key focus for Sense4Baby's partner, the West Health Institute. The startup, which now has six people on staff, is the first to commercialize technology developed at West and the first to be based in the institute's La Jolla incubator space, which is where the team is still located. The West Health Investment Fund also led Sense4Baby's $4 million first round of funding earlier this year.
While the company's current offering only has clearance for use by healthcare providers, Grossman told MobiHealthNews that Sense4Baby sees a future opportunity in self-use monitors, and it has an (IRB approved) usability study to that end already underway at Scripps.
"Women could potentially do this [non-stress] testing on their own in their home or in their workplace," Grossman said. "It would be a tremendous convenience for moms who usually come in twice a week toward the end of their pregnancy to do the testing if they are high risk. For the study we are doing at Scripps, pregnant women who are low-risk get training [about 30 minutes with the study's nurse coordinator] and are given a system to try themselves at home. With our software we can see via the portal if they were able to apply it and use it correctly and physicians can compare that testing to what was done by a nurse in the office. We want to understand whether it is feasible for women to do this and self-apply the device. Thus far, it seems to be extremely easy to use. We have had almost 100 percent success."
Pointing to the cost savings and the convenience of it, Grossman said "that there are tremendous benefits to women if they are able to do this themselves at their homes."