US requires all importing companies to appoint a registered United States Food and Drug Administration (USFDA) agent to act as a connection between the company and the USFDA. “When marketing a device which is a predicate device to USFDA, the manufacturers are required to prove substantial equivalence by submitting a 510(k) application, a Premarket Approval application (PMA). Understanding the requirements and checking for exemptions of premarket notification [510(k)] will save time and resources for manufacturer before deciding upon submission.”
The article cited AMA's "Global Neuronavigation Systems Market Study" explored substantial growth in North America and CAGR of 15.35%. According to the report, Developments in Augmented Reality (AR) Navigation Systems
is one of the primary growth factors for the market. Increasing Need and Rising Demand for Accurate and Precise Systems
is also expected to contribute significantly to the Neuronavigation Systems market growth. Overall, Neurosurgery
applications of Neuronavigation Systems, and the growing awareness of them, is what makes this segment of the industry important to its overall growth. The End User, such as Hospitals, is boosting the Neuronavigation Systems market. Additionally, the rising demand from SMEs and various industry verticals, macro-economic growth are the prime factors driving the growth of the market.
AMAs Analyst on the Global Neuronavigation Systems market identified that the demand is rising in many different parts of the world as "Increasing Adoption of Surgical Navigation Systems in Ambulatory Settings and Untapped APAC market
".
The report provides an in-depth analysis and forecast about the industry covering the following key features: o Industry outlook including current and future market trends, drivers, restraints, and emerging technologies o Analyses the Global Neuronavigation Systems market according to Type, Application, and regions o Analyzes the top 10 players in terms of market reach, business strategy, and business focus o Provides stakeholders insights and key drivers & trends of the market
**The market is valued based on weighted average selling price (WASP) and includes any applicable taxes on manufacturers. All currency conversions used in the creation of this report have been calculated using constant annual average 2018 currency rates.
Market Size Estimation In market engineering method, both top-down and bottom-up approaches have been used, along with various data triangulation process, to predict and validate the market size of the Neuronavigation Systems market and other related sub-markets covered in the study.
o Key & emerging players in the market have been observed through secondary research. o The industrys supply chain and overall market size, in terms of value, have been derived through primary and secondary research processes. o All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Data Triangulation The overall Neuronavigation Systems market size is calculated using market estimation process, the Neuronavigation Systems market was further split into various segments and sub-segments. To complete the overall market engineering and arriving at the exact statistics for all segments and sub-segments, the market breakdown and data triangulation procedures have been utilized, wherever applicable. The data have been triangulated by studying various influencing factors and trends identified from both demand and supply sides of various applications involved in the study. Along with this, the Global Neuronavigation Systems market size has been validated using both top-down and bottom-up approaches.