Innovative Advancements in Medical Imaging Devices Hold the Potential to Save Lives

NEW YORK, May 27, 2020 /PRNewswire/ -- The medical device industry is seeing strong growth thanks to new technologies and developing medical infrastructure around the world. As emerging economies invest more in healthcare, the medical device market is being impacted accordingly. Therefore, by 2022, more than 30% of the global healthcare expenditure is expected to arise from emerging economies. In developing countries, medical device companies leverage low manufacturing and labor costs to generate larger profit margins for investors. As a result, the medical device market is projected to grow by USD 134.2 Billion during the period of 2020-2024 and at a CAGR of over 5%, according to Technavio. Among the many technologies that help transform the medical device market are the Internet of Things (IoT), machine learning and advanced 3D printing. For instance, IoT in healthcare is increasingly used to promote active patient engagement and patient-centric service delivery through advanced devices that are constantly connected with each other. Yet despite the 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. Research provided by SelectUSA, a U.S. government-wide program led by the U.S. Department of Commerce, approximations that by 2023, the medical device market is projected to grow to USD 208 Billion. Izotropic Corporation (OTC: IZOZF) (CSE: IZO), Hologic, Inc. (NASDAQ: HOLX), Stryker Corporation (NYSE: SYK), Medtronic plc (NYSE: MDT), Boston Scientific Corporation (NYSE: BSX)

Some of the fastest growing segments in the medical device market by application include diagnostic devices like patient-monitoring systems, MRI machines, diagnostic imaging equipment (including X-ray devices and other diagnostic imaging), and ultrasonic scanning devices. According to a report by Stratistics MRC, the Global Medical Imaging market accounted for USD 29.8 Billion in 2016 and is expected to reach USD 45.1 Billion by 2022. An example of how recent innovations can help the imaging segment was reported by Forbes, which reported that Zebra Medical Vision's machine learning algorithms will be used within this partnership to create 3D models of patients from X-ray images. "The algorithms were trained on very large volumes of CT scans and the inference is from 2D images of the same patients. Zebra-Med's strategic access to hundreds of millions of images enables these types of breakthroughs," explains Eyal Gura, the firm's co-founder and CEO.

Izotropic Corporation (OTC: IZOZF) (CSE: IZO) announced yesterday breaking news that, "it has engaged company advisor and FDA Consultant, Anita Nosratieh Ph.D., to develop and manage the Company's application for FDA medical device approval of its dedicated Breast CT Imaging System.

The first stage towards FDA approval is focused on developing a detailed pre-submission strategy and application, which will be managed by Nosratieh. Her extensive experience includes a position as a lead reviewer at the FDA in the approval process of breast cancer screening and diagnostic devices. The pre-submission meeting provides the opportunity to open a dialogue and obtain FDA feedback prior to the actual submission for medical device approval, resulting in a smoother and more efficient approval process which may expedite patient access to breast CT. Tasks associated with the application include finalizing product and indication for use statements, device labelling terms, and clinical and validation study designs to verify future breast CT marketing claims.

The Company expects the development and submission of the application for the pre-submission meeting to be completed within 8-10 weeks. An interactive period of clarifying questions may then be entered into, resulting in a formal written response from the FDA. The typical timeline for the formal response is 90 calendar days. Once the formal written response is received, the Company can schedule the pre-submission meeting.

Additionally, Nosratieh will develop a strategy and present breast CT to the FDA's Center for Devices & Radiological Health Payor Communication Task Force, a program that facilitates 'medical device sponsors to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions.'

The Company will continue to announce updates to keep its shareholders informed as to its progress and timelines towards the pre-submission meeting, FDA approval processes and US payor adoption of its Breast CT Imaging System."

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Hologic, Inc. (NASDAQ: HOLX) announced earlier last year that the U.S. Food and Drug Administration (FDA) has approved 3DQuorum(TM) Imaging Technology, powered by Genius AI(TM). 3DQuorum technology works in tandem with Hologic's Clarity HD(TM) high resolution imaging technology to reduce tomosynthesis image volume for radiologists by 66%. In 2009, Hologic revolutionized breast cancer screening with the introduction of the Genius(TM) 3D mammography(TM) exam, the only mammogram clinically proven and FDA approved as superior for all women, including those with dense breasts, compared to 2D mammography alone. Today, there are nearly 7,000 Hologic 3D Mammography systems in use in the U.S. alone, and tomosynthesis is now the standard of care for annual breast cancer screening. These advancements serve as the foundation for Genius AI technology, Hologic's new core artificial intelligence platform designed to provide advanced cancer detection, operational efficiency and clinical decision support across the breast cancer care continuum.

Stryker Corporation (NYSE: SYK) announced last year that it had completed the acquisition of Mobius Imaging, LLC, a leader in point-of-care imaging technology, and its sister company, GYS Tech, LLC (DBA Cardan Robotics). "Mobius Imaging and Cardan Robotics bring expertise in advanced imaging and robotics, as well as a robust product pipeline, that will provide Stryker the opportunity to increase its presence in Orthopaedics, Spine and Neurotechnology," said Spencer Stiles, Stryker's Group President, Orthopaedics and Spine. "With this acquisition, we are positioned to make healthcare better by providing more complete procedural solutions, including sales, service, and support. We remain committed to our surgeons and helping them achieve the best possible outcomes for their patients."

Medtronic plc (NYSE: MDT) announced earlier this year the CE (Conformité Européenne) Mark for Percept(TM) PC neurostimulator; it is the only Deep Brain Stimulation (DBS) system to be launched in the European Union (EU) with BrainSense(TM) technology that can sense and record brain signals while delivering therapy to patients with neurologic disorders, such as Parkinson's disease. "DBS is proven to significantly improve motor function in people with Parkinson's disease compared to standard medication alone - but with currently-available systems, physicians need to make therapeutic decisions mostly based on clinical assessments and patient-reported information," said Professor Andrea Kühn, Head of Movement Disorders and Neuromodulation, Charité University Hospital, Berlin. "Percept PC with BrainSense technology is a game changer. Patients and their care teams will have objective patient-specific brain signal data - including data recorded outside the clinic in patients' everyday lives. With this technology, doctors could tailor therapy more precisely to the individual needs of each patient based on data from neuronal activity."

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(TM) 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.

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