North America Ultrasound Devices Market - Segmented by Application, Technology, Type, and Geography - Growth, Trends, and Forecast (2018 - 2023)
Ultrasound is a medical imaging modality that uses high-frequency sound waves to visualize the internal organs of the body. It transmits high-frequency ultrasonic sound waves into the body of the patient, which are reflected by the organs into the probe and are transmitted to a display to generate the image. The North America ultrasound devices market is expected to register a CAGR of 5.5% during the forecast period of 2018–2023.
Government and Private Funding for R&D in Ultrasound Imaging
The governments across the world are focusing on the promotion and support of industrial research. Several tax incentives have been provided for industries to establish R&D units, with highly improved imaging facilities, such as ultrasound. The long-term goal of these initiatives is to develop innovative, disruptive, safe, non-invasive ultrasound technologies that enable or enhance interventional therapies for the treatment of diseases, injuries, abnormalities, and other conditions. The types of ultrasound interventional therapies to be considered include ultrasound thrombolysis, high-intensity focused ultrasound, and sonophoresis.
FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, re-label, and import medical devices and radiation-emitting electronic products, such as ultrasound equipment. As per the Code of Federal Regulation 21 CFR Part 807, manufacturers and initial distributors of ultrasound equipment must register with the FDA, and registrations must be submitted electronically, unless a waiver has been granted by the FDA. The manufacturers should follow all the steps set by FDA, from equipment registration to submitting a premarket notification. The same applies for premarket approval, investigational device exemption, quality system regulation, labeling and medical device reporting. FDA possesses excessive regulatory authority. Proving efficacy is much more expensive and time-consuming than proving safety. These stringent FDA regulations are restraining the growth of North American ultrasound devices market.
Additionally, the lack of skilled professionals to handle the equipment is also restraining the ultrasound devices market.
United States to Dominate the Market
The United States dominates the market due to improvements in the ultrasound technology, increasing the need for accurate and early diagnosis, and improving healthcare infrastructure. Also, the shifting trend towards home healthcare and remote patient monitoring to reduce hospitalization cost is augmenting the demand for handheld ultrasound devices.
Major Players: ANALOGIC CORPORATION, FUJIFILM, GE HEALTHCARE, HITACHI MEDICAL CORPORATION, PHILIPS HEALTHCARE, SAMSUNG HEALTHCARE, SIEMENS HEALTHINEERS, and TOSHIBA MEDICAL SYSTEMS CORPORATION, among others..
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