NEW YORK, March 27, 2020 /PRNewswire/ -- The medical device industry is undergoing significant changes in terms of efficiency and scope as new technologies push the boundaries of what's possible. Technology is transforming the medical device market with features such the Internet of Things (IoT), machine learning and advanced 3D printing. For example, IoT in healthcare is increasingly being used to promote active patient engagement and patient-centric service delivery through advanced devices that are constantly connected with each other. Furthermore, the influence of emerging economies on the medical device market is expected to be substantial, as healthcare infrastructure is now being properly established. As a result, by 2022, more than 30% of the global healthcare expenditure is expected to arise from emerging economies. Furthermore, combining these two factors positions the industry for strong growth around the world. Yet, in the meantime and despite global growth, the United States is still the largest medical device market, with a value of USD 156 Billion, which accounted for 40% of the global industry in 2017. And research provided by SelectUSA, a U.S. government-wide program led by the U.S. Department of Commerce, estimates that by 2023, the medical device market is expected to grow to USD 208 Billion. Nemaura Medical, Inc. (NASDAQ: NMRD), Boston Scientific Corporation ( NYSE: BSX), Baxter International Inc. ( NYSE: BAX), Smith & Nephew plc (NASDAQ: SNN), iRhythm Technologies, Inc. (NASDAQ: IRTC).
Some of the most promising, high-growth-opportunity segments in the medical device market by application include surgical and infection control devices, general medical devices, cardiovascular devices, orthopedic devices and wearable monitoring healthcare technologies. Wearables, in particular, are a new trend that has been evolving in the medical technology sector in recent years. These devices can be used to remotely monitor a patient's various physiological parameters. In addition, new wearable monitoring devices, equipped with the Internet of Things (IoT) technology, are able to communicate with smartphones, transferring crucial data to user friendly applications. Overall, the most commonly measured data include vital signs such as heart rate, blood pressure, blood oxygen saturation, blood glucose levels as well as physical activities through the use of electrocardiogram (ECG), ballistocardiogram (BCG) and other devices. Additionally, it is important to note that the wearable tech industry was worth nearly USD 23 Billion in 2018 and is forecast to grow at a compound annual growth rate (CAGR) of 19% to reach USD 54 Billion by 2023, GlobalData indicates.
Nemaura Medical, Inc. (NASDAQ: NMRD) announced breaking news last week that, "it is preparing for the launch of sugarBEAT® in the U.S. under the wellness category following recent feedback from the U.S. Food and Drug Administration (the "FDA"). The Company is prioritizing launch plans in the U.S. and is considering various options to expedite the launch, including potential partnering in continuation of its on-going discussions with multi-national companies.
'Under the FDA's wellness category, the Company intends to make sugarBEAT® available to any adult wishing to be empowered with knowledge of how different lifestyle, dietary and health and wellbeing factors impact their sugar levels and is potentially appropriate to the pre-diabetic and diabetic market. This gives us access into the US market, which we believe is the world's largest diabetic market by value. As sugarBEAT® is adopted, we believe we will have the benefit of gathering data on a large scale, and from a diverse patient demographic, that we believe has never previously been achieved using CGM. Nemaura intends to use this data to develop artificial intelligence-based predictive algorithms that in the future potentially enable us to open up a number of new opportunities for the prevention and management of diabetes in an affordable and scalable manner. To the best of our knowledge, no other CGM has yet been allowed under the wellness category by the FDA, and this is one of the most important milestones for us thus far,' stated Dr. Faz Chowdhury, Nemaura's CEO.
The FDA general wellness category use is defined as: (1) An intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or disease conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
The first phase of the commercial launch of sugarBEAT® began in the U.K. after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company focused on scaling up its manufacturing operations. The U.K. licensee of sugarBEAT®, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT®…"
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Boston Scientific Corporation ( NYSE: BSX) announced last year primary endpoint results from the EVOLVE Short DAPT clinical trial, the first prospective study initiated in the U.S. to examine the safety of a shortened duration of dual antiplatelet therapy (DAPT) in patients at high risk for bleeding. Results were presented during a late-breaking clinical science session at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in San Francisco, and demonstrated that a three-month regimen of DAPT is non-inferior to a 12-month or longer regimen in patients with an increased risk of bleeding after being treated with the SYNERGY™ Bioabsorbable Polymer (BP) Stent. "These data prospectively demonstrate a low rate of adverse events for patients who are at high risk for bleeding and who then stop DAPT at three months," said Ajay Kirtane, M.D., director of Cardiac Catheterization Laboratories at Columbia University Irving Medical Center/New York-Presbyterian Hospital and principal investigator of the EVOLVE Short DAPT trial.
Baxter International Inc. ( NYSE: BAX) announced last month the U.S. Food and Drug Administration (FDA) clearance of Q-NRG+, a metabolic monitoring device utilizing indirect calorimetry (IC) technology. IC is considered the "gold standard"1 to accurately measure a patient's calorie needs, or resting energy expenditure (REE). These readings can help inform prescription and administration of nutrition therapy, which may include parenteral nutrition (PN), the intravenous administration of nutrients. Q-NRG+ is expected to be available in the United States beginning at the ASPEN 2020 Nutrition Science & Practice Conference taking place March 28 – 31, 2020 in Tampa, Florida.
Smith & Nephew plc (NASDAQ: SNN) announced earlier this month the U.S. launch of the new PICO 14 Single Use Negative Pressure Wound Therapy System (sNPWT) which has a pump duration of up to 14 days. The new pump builds on the features and advantages of previous PICO sNPWT variants, and comes with an enhanced pump which requires less user intervention. 14 days of therapy may be particularly relevant for patients where both the risk of surgical site complications (SSCs) and the consequence of obtaining them are high, such as cardiothoracic surgery and abdominal surgery. Complications following coronary artery bypass graft surgery (CABG) can devastate patient lives, with up to a 35% in hospital mortality rate associated with deep sternal wound infections and mediastinitis and length of stay as long as 23 days per patient, which incurs substantial healthcare associated costs.
iRhythm Technologies, Inc. (NASDAQ: IRTC) announced last year a collaboration with Verily, an Alphabet company, focused on the development of solutions aimed at improving the screening, diagnosis and management of patients with atrial fibrillation (AFib). This collaboration brings together iRhythm's expertise in AI based arrhythmia diagnosis and Verily's advanced health data analytics technologies to address the millions of patients living with undiagnosed AFib. The iRhythm and Verily collaboration aims to address this significant, underserved population at risk for asymptomatic or silent AFib. Under the terms of the agreement, iRhythm and Verily plan to collaborate on solutions capable of providing earlier warnings, enabling the identification and management of patients that could otherwise go undiagnosed until they have a cardiac event, such as a stroke.
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