Federal Regulators Affirm the Value of Wearable Devices for Medical Use

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Apr 08, 2020, 09:00 ET

NEW YORK, April 8, 2020 /PRNewswire/ -- The current pandemic has drastically changed the world's social and economic landscape since the virus was first identified. Countries have shut down schools and businesses, restricted travel, canceled entertainment and sporting events, and are encouraging the public to stay at home as much as possible. Last week, the World Health Organization (WHO) and UNICEF announced an agreement to work together on the pandemic response through the Solidarity Response Fund powered by the United Nations Foundation and Swiss Philanthropy Foundation. The money collected through the fund will be used, among others, to train and equip communities and health-care workers to prevent or detect viral infection. The "pandemic requiring extraordinary global solidarity to urgently respond," stated Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. "I'm pleased that UNICEF joined the Solidarity Response Fund. With their extensive experience both in fundraising and in implementing programs, this partnership will help us to work together closely to save lives." Nemaura Medical, Inc. (NASDAQ: NMRD), Medtronic plc (NYSE: MDT), Johnson & Johnson (NYSE: JNJ), Becton, Dickinson and Company (NYSE: BDX), Masimo Corporation (NASDAQ: MASI)

While the world is coming up with ways to battle the pandemic, new technology and innovative medical devices offer a possible solution to various issues the medical field is currently struggling with. For example, a report by WIRED indicates that a wearable device, which had been approved by the US Food and Drug Administration (FDA) in May 2019 as a tool for remotely monitoring patients recovering from opioid overdoses, has recently been retooled to help doctors manage patients suffering from the pandemic virus. FDA officials approved the device within days. "This way, the caregivers can go about their normal days and only get alerts, only pay attention when they need to," explains Joe Kiani, inventor and founder of Masimo. "And then, if for some reason they don't respond within a period, it elevates the alarm to other care providers."

Nemaura Medical, Inc. (NASDAQ: NMRD) just announced breaking news that, "it immediately plans to repurpose and commercialise the CE approved sugarBEAT^® platform as a CTM making use of the inbuilt temperature sensor which is capable of continuously tracking body temperature. Nemaura is considering various options to expedite the launch of a CTM, including potential partnerships and direct to consumer sales.

As a direct response to the COVID-19 pandemic, Google's Verily is developing a small body worn temperature patch that transmits data to a phone application to provide timely notification of fever and support earlier diagnosis and treatment of a viral infection like the flu or coronovirus¹. Nemaura Medical sees a significant commercial opportunity to utilise the sugarBEAT^® platform specifically for CTM purposes with data being automatically sent by low energy blue tooth to a mobile phone app from which it can be sent to a member of family or caregiver for remote tracking of body temperature.

Several diseases including COVID-19 are characterised by fever (an increase in body temperature) meaning that temperature monitoring is a vital tool in the detection of such a condition and consequently a means of containing the spread of the disease through isolation. Measuring body temperature on a continuous basis may also be used to track the course of a disease and so allow physicians to analyse the effectiveness of treatments and thus pro-actively adapt to improve outcomes.

Dr. Chowdhury, CEO of Nemaura stated, "body temperature can vary depending on the age of the person, their level of (recent) physical activity, the time the measurement is taken and importantly where on the body the temperature is taken. For this reason the ability to track the temperature continuously over time and measure the rate at which it is rising or falling would be a superior form of monitoring a person than sporadic measurements taken using a thermometer."

Nemaura recently announced that it is planning the launch of proBEAT™ in the USA, a wellness device and digital service targeting 88 million pre-diabetics and over 34 million diabetics², to help them make informed decisions through prompts relating to blood glucose levels caused by individual diet and lifestyle to help prevent diabetes or manage Type 2 diabetes."

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American Diabetes Association

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Medtronic plc (NYSE:MDT), the global leader in medical technology, announced last month it is publicly sharing the design specifications for the Puritan Bennett™ 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19. This decision is consistent with the recent FDA Guidance and in accordance with the public health and medical response of governmental agencies globally. Introduced in 2010, the PB 560 is sold in 35 countries around the world. This ventilator's ability to be used in a range of care settings, as well as its technology and design, make it a solid ventilation solution for manufacturers, inventors, start-ups, and academic institutions seeking to quickly ramp up ventilator design and production. The PB 560 ventilator is a compact, lightweight, and portable ventilator that provides airway support for both adults and children. It can be used in clinical settings and at home and provides mobile respiratory support.

Johnson & Johnson (NYSE: JNJ) announced on March 30th, 2020 the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company's manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process. Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.

Becton, Dickinson and Company (NYSE: BDX), a leading global medical technology company, and BioMedomics, a privately held, North Carolina-based clinical diagnostics company, announced last week, the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics, will be available through BD and distributed exclusively by Henry Schein, Inc. to health care providers throughout the United States. The test does not require special equipment and may be used in a laboratory or at the point of care. The test detects antibodies in the blood that are produced by the body in response to coronavirus infection. These antibodies are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure, which helps clinicians determine who has been exposed to the coronavirus, even if a person didn't exhibit any symptoms of the COVID-19 disease. Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combatting COVID-19.

Masimo Corporation (NASDAQ: MASI) announced on April 7th, that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet™ to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness."

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