Royal Philips joins the list of companies taking advantage of the relaxed FDA guidelines with its plans to launch its prenatal monitoring platforms in the U.S.
The Fetal and Maternal Pod and Patch will be able to continuously monitor both the maternal heart rate and fetal heart rate, as well as uterine activity, with a dispensable electrode patch. The tech is intended for high-risk pregnancies. Each patch can be used for 48 hours, and is placed on the pregnant patient’s stomach.
The company said this latest patch will be part of a broader product line dubbed the Avalon Fetal Monitoring Portfolio, which includes a transducer system and an obstetrical surveillance and information system called the IntelliSpace Perinatal.
This news comes after the FDA released a new, less restrictive stance on its enforcement policy for noninvasive fetal- and maternal-monitoring devices as a result of the pandemic. However, these relaxed guidelines are only in effect until HHS calls off the public health emergency. A representative from the company told MobiHealthNews that it was still committed to obtaining and FDA clearnce for this new tool.
While the product is new to the U.S. market, it has already landed a CE mark in Europe and been cleared in Australia, New Zealand and Singapore.
This wasn’t the only maternity-health-focused news for Royal Philips this week. Today the company also announced its plans to launch Lumify, a handheld telehealth ultrasound product in Japan. While ultrasounds are often used in the maternity space, Philips notes that the versatility in the technology can be used for a number of conditions.
Lumify is a portable, and is connected to a smartphone platform that can show the images. The company is pitching the tech as a more affordable way to provide care. It was launched in the U.S. as far back as 2015, after it landed an FDA clearance.
“Its transducer connects to a smart device such as a tablet, making it a compact and highly durable solution,” Matthijs Groot Wassink, general manager for access and obstetric ultrasound at Philips, said in a statement. “In addition, by utilizing Philips’ Lumify with Reacts capability, real-time ultrasound images can be shared between medical staff involved in collaboration during imaging procedures.”
WHY IT MATTERS
Philips is pitching both of these products as a way to help solve problems for coronavirus-related issues. For example, it is saying that the Fetal and Maternal Pod and Patch will help monitor patients with less face-to-face exposure.
“Remote monitoring during labor has always provided multiple benefits to expectant mothers, including comfort, mobility, and flexibility. But during the COVID-19 pandemic, the need for mobile solutions during pregnancy is greater than ever,” said Peter Ziese, general manager for monitoring and analytics at Philips. “With this new patch, clinicians now have access to an innovative tool to help monitor pregnant women during COVID-19, helping to deliver comfort to these mothers during a particularly stressful time.”
As for Lumify, while CT scans continue to be the main way clinicians screen patients with suspected COVID-19, ultrasound technology has become a second method. Philips is positioning Lumify as a lower-priced alternative to standard ultrasound tools.
It’s no secret that Philips is interested in the maternity and newborn space. On a trip to Philips’ Cambridge, Massachusetts, research labs last fall, the company gave MobiHealthNews a peek at its new inventions, including a neonatal intensive care unit that seeks to completely overhaul both the technology and design of a typical NICU with connected devices.
But Philips is hardly alone in its development of maternity-monitoring tools. Butterfly has become a popular handheld ultrasound tool. Like Lumify, it also has a smartphone component to it. The company received clearance for the device in 2017. However, it found itself in hot water when its Auto Ejection Fraction Tool and its Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software updates without getting proper FDA clearance.