Innovations compressed from months and years to days due to COVID-19

Innovations compressed from months and years to days due to COVID-19
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Monday, July 6, 2020

 
 
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Abbott's Bluetooth connected implantable heart rhythm devices score FDA clearance

By Laura Lovett

Abbott’s Bluetooth connected cardioverter defibrillator and cardiac resynchronization therapy defibrillator, part of the Gallant product line, scored FDA clearance this morning.

Patients using the technology can connect it to a smartphone app, called MyMerlinPulse, which will let both patients and providers see transmission history and device performance. The app is also designed to nudge patients to set up their next doctor’s appointment. Doctors are able to tap into the app in order to remotely monitor patients and detect any potentially problematic events. 

This FDA designation includes the MyMerlinPulse App and the software to program the Gallant family of devices on the programmer, according to a company spokesperson. 

The tool landed a European CE mark in February, and is geared towards individuals with reduced cardiac function. 

WHY IT MATTERS 

Heart conditions are common in the US. In fact, atrial fibrillation impacts between 2.7 million and 6.1 million people in the United States, according to the CDC. The company is pitching this product as another way for doctors to monitor their patients' heart conditions remotely. 

"The ability for patients to stay connected to their doctors via their implanted device and a smartphone app has the potential to change how healthcare providers and patients communicate with each other," Dr. Raffaele Corbisiero, director of electrophysiology and pacing at Deborah Heart and Lung Center, Browns Mills, said in a press statement. "The FDA's approval of Abbott's Gallant devices enables doctors to provide a more collaborative approach to treatment plans and the increased bond between a patient and provider will lead to better outcomes for all."

THE LARGER TREND 

This isn’t Abbott’s first foray into cardiac monitoring. In 2017, the FDA cleared its Confirm Rx Insertable Cardiac Monitor (ICM), an implantable device that is able to track a patient’s heart rhythms and send the data to a smartphone app via Bluetooth. 

This was shortly followed by Abbott subsidiary St. Jude Medical gaining FDA clearance for MyMerlin companion app to its Confirm Rx Insertable Cardiac Monitor

However, Abbott’s experience in the digital health space goes beyond just cardiac care. It has long been known for its role in the diabetes care. In fact, in June it announced the FDA clearance of the continuous glucose monitoring system the FreeStyle Libre 2

It has also dipped into neurological care. It also launched a system where its deep brain stimulation device can connect to an iPad mini where clinician can program their patient’s therapy and monitor outcomes.

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MFB Fertility signs contract with US Air Force for fertility testing >>

By Mallory Hackett

The U.S. Air Force has inked a $1.3 million deal with MFB Fertility in order to provide military members and their partners the former’s home fertility tests.

The Air Force’s AFWERX office will invest in Proov, an at-home ovulation test with FDA clearance. The test works by measuring Pregnanediol Glucuronide (PdG), the urine metabolite of progesterone, which is released by the ovary after ovulation. High levels of PdG over multiple days can confirm that successful ovulation took place.

The contract will provide free Proov kits to Air Force couples upon request and connect them to fertility specialists.

WHY THIS MATTERS

Infertility is a common issue, according to the Department of Health and Human Services. It affects about 12% of couples in the United States.

The problem is even greater among military couples, however. A survey about reproduction from the Service Women’s Action Network found that 37% of respondents had trouble getting pregnant when they were actively trying to do so.

“While being in the Air Force for many years and understanding how the healthcare system works, I have seen colleagues and friends struggle to start a family,” U.S. Air Force Major Eric Straub said in a statement. “With the Proov technology, it is my hope to change the stigma surrounding the lack of fertility resources and provide proactive fertility diagnostics and treatment options for Airmen and their families.”

Through this contract, Air Force couples will have access to a possible first step in achieving their fertility goals.

THE LARGER TREND

In December of last year, the Air Force made a smaller investment of $50,000 into Proov through a Small Business Innovation Research grant. The original funds served the same purpose as the new contract – to provide free testing kits and fertility consultations to military couples.

In March, Proov got the FDA green light for its at-home ovulation test. The company rolled out its mobile app this spring, which shows users their progesterone and LH levels, as well as a graph of their hormone levels.

The AFWERX office was founded in 2017 to “connect Airmen to solutions across the force: whether that be funding, collaborating with industry, or simply receiving guidance on a project,” according to its website.

The Air Force has entered into other agreements with health companies in the past. In 2018, it entered into a patent licensing agreement with Philips Healthcare for Battlefield Airmen Trauma Distributed Observation Kit.

ON THE RECORD

“With this new contract from the US Air Force, we are proud to give simple fertility care access to couples who are trying to start a family,” said Amy Beckley, MFB Fertility’s founder and CEO, in a statement. “From our research, we saw significant issues in the lack of support and care from military couples trying to conceive. At Proov, we want to continue carrying out our mission to provide women with the knowledge and resources about their reproductive health that can help them conceive without the costly treatments and emotional and physical stress that I personally experienced.”

 

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