#Natus peloton trial#

The existence of this material weakness and of any other ineffective controls over our financial reporting could result in one or all of the following: Controls and Procedures-Management’s Report on Internal Control Over Financial Reporting. This material weakness is more fully described in Item 9A. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis. The first fiscal year exemption for internal controls over financial reporting does not apply to controls over purchase price accounting, which constituted a material weakness in our internal control over financial reporting. Management’s assessment of our internal control over financial reporting as of December 31, 2017, identified a control was not effective because we did not perform an effective risk assessment relating to significant acquisitions, and as a result, we did not adequately design control activities over the accounting for the acquisition of Otometrics. As part of this internal control over financial reporting and our independent registered public accounting firm is required to attest to and report on the effectiveness of our internal control over financial reporting. Under Section 404 of the Sarbanes-Oxley Act of 2002 and rules promulgated by the SEC, companies are required to conduct an annual comprehensive evaluation of their internal control over financial reporting.

#Natus peloton trial#

If the Institutional Review Boards at the clinical trial sites concur with the non-significant risk determination, the manufacturer may begin the clinical trial. If the manufacturer deems the product a non-significant risk device, the product will be eligible for more abbreviated investigational-device exemption requirements.

An investigational-device exemption approval provides for a specified clinical protocol, including the number of patients and study sites. If the FDA and the Institutional Review Boards at the clinical trial sites approve the investigational-device exemption application for a significant-risk device, the manufacturer may begin the clinical trial. The investigational-device exemption application must be supported by appropriate data, such as animal and laboratory testing results.

In order to conduct a clinical trial on a significant-risk device, the FDA requires manufacturers to apply for and obtain, in advance, an investigational-device exemption. The FDA may require results of clinical trials in support of a 510(k) submission and generally requires clinical trial results for a premarket approval application. Forward-looking statements in this Item 1 include, but are not limited to, statements regarding the effectiveness and advantages of our products, factors relating to demand for and economic advantages of our products, our plan to develop and acquire additional technologies, products or businesses, our marketing, technology enhancement, and product development strategies, and our ability to complete all of our backlog orders.

The words “may,” “will,” “continue,” “estimate,” “project,” “intend,” “believe,” “expect,” “anticipate,” and other similar expressions generally identify forward-looking statements. These statements include, among other things, statements concerning our expectations, beliefs, plans, intentions, future operations, financial condition and prospects, and business strategies.

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about Natus Medical Incorporated (“Natus,” “we,” “us,” or “our Company”).