This morning Abbott revealed that its much anticipated integrated continuous glucose monitoring system the FreeStyle Libre 2 is now FDA cleared for adults and kids over the age of 4 with diabetes. 

The latest product is able to continuously transmit glucose data every minute, and users can set the system to send alarms when their glucose is too high or too low. Previously users had to scan the sensor in order to get a glucose read.  

The way it works is users apply a small sensor, roughly the size of two stacked quarters, on the back of their upper arm. The system will then be able to monitor their glucose levels. The wearable can last for up to 14 days, which the company is pitching as one of the longest-lasting iCGMs. 

Like other versions of the FreeStyle Libre, the system will be able to transmit data to a handheld device where users can view their glucose readings and trends. According to the company, the system is developed to eventually be used with a smartphone device. 

This announcement has been a long time coming. As far back as July of 2019, the company announced its plans to vamp up its manufacturing capacity, in part to clear the way for the U.S. launch of the  FreeStyle Libre 2. 

According to the MedTech device company the system will be rolled out at pharmacies across the US within the next coming weeks. It said it will offer the FreeStyle Libre 2 at the same price point as its predecessor, which came onto the market in 2018.  

WHY IT MATTERS 

Diabetes impacts roughly 34.2 million adults in the United States, according to the CDC. It is associates with kidney failure, lower-limb amputations and adult blindness. 

It can also be a finical burden on the health system and the patients, with costs associated with the condition totaling at approximately $327 billion a year, according to the  American Diabetes Association. The company is pitching this as an easier way to manage the condition at a less expensive price point. 

"Managing diabetes is expensive, even for those with insurance coverage," Jared Watkin, senior vice president for Diabetes Care at Abbott, said in a statement. "From the start, Abbott designed FreeStyle Libre technology with affordability in mind. We set a global price for our sensing technology that's closer to that of traditional blood glucose fingerstick systems, and significantly less than other CGMs, because we wanted to make sure our life-changing technology was accessible to as many people as possible."

THE LARGER TREND 

In 2017 Abbott’s Freestyle Libre system became the first CGM to be FDA cleared for use without fingersticks. At the time the system was cleared for 10-day use, but in 2018 Abbott got another clearance for its FreeStyle Libre 14 Day Flash Glucose Monitoring System. 

Just last week a new study published in US Endocrinology found Abbott’s continuous glucose monitoring system, the FreeStyle Libre, demonstrated significant cost savings for diabetic care compared to traditional fingerstick testing. 

Abbott isn’t the only major CGM maker in the U.S.  Dexcom and Medtronic are among the other big names in the industry. Just this week, rival company Dexcom announced that its G6 Pro would begin shipping in July. Among other features, the G6 Pro allows for blinded and unblinded modes of use, and can read glucose values up to every five minutes. Like the FreeStyle Libre 2, it is also cleared to be used without the need for fingerstick calibrations. 

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. 

MARKET SNAPSHOT 

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.