Net Medical Announces Joint Venture with Leading FDA Regulatory Firm, Smith Associates
Net Medical (OTC Pink:NMXS) has partnered with Smith Associates to enhance clinical trial development, focusing on identifying flu, common colds, and COVID. This collaboration follows FDA guidelines and aims to assist manufacturers in obtaining Emergency Use Authorizations and 510k clearances for their tests. With over 100 years of regulatory experience, Smith Associates will streamline the FDA approval process. CEO Dick Govatski expressed optimism about this partnership, indicating it as a key growth area for Net Medical.
- Formation of a strategic partnership with Smith Associates enhances clinical trial capabilities.
- Partnership supports manufacturers in obtaining FDA approvals for COVID tests.
- Smith Associates offers over 100 years of regulatory experience, improving approval process efficiency.
- None.
ALBUQUERQUE, NM / ACCESSWIRE / June 6, 2022 / Net Medical (OTC Pink:NMXS) announced today it has formed a strategic partnership with Smith Associates for development and support of sophisticated clinical trials with multiple purposes such as the ability to specifically identify flu, common colds or COVID conditions.
The usability and clinical trial programs, which follow FDA guidelines, are jointly managed by Smith Associates and Net Medical. Smith Associates ensures that Net Medical has all the proper documentation needed to be compliant. Net Medical conducts trials in both English and Spanish, the two most important languages spoken in the U.S.
This is in response to increasing demand from both domestic and international manufacturers of COVID-19 tests to gain FDA approvals for Emergency Use Authorization (EUA) and 510k clearances. To gain approvals, medical device and related companies are subjected to rigorous evaluations and examinations by the FDA.
This partnership provides the necessary skills and experience to streamline the evaluation process for the manufacturers.
Smith Associates brings a combined 100-years of FDA regulatory background and experience for medical device and other medical companies seeking FDA approvals. This includes the most common route to clearance in the United States, the 510k submission (PMN), as well as Pre-Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s.
Christian Smith, Director of New Business Development within Smith Associates, reached out to Net Medical with the idea of working alongside their family-owned company to help small business succeed in getting their medical devices cleared. Along with founders EJ and Yolanda Smith, they have put together over 280 successful 510k clearances and countless PMA's across all Centers for Devices and Radiological Health (CDRH) at the FDA.
Net Medical CEO Dick Govatski said, "We're delighted with this valuable new partnership. Manufacturers of rapid antigen and PCR tests need custom designed protocols that can be submitted to the FDA for Over the Counter (OTC) products that are more readily available for consumers to check on and monitor their condition. This venture with Smith Associates is an important growth area for Net Medical."
For more information, call 505-255-1999 X 320. Visit www.netmedical.com. Email ir@netmedical.com.
About Net Medical - publicly traded (OTC Pink:NMXS) since 1999.
Net Medical has two operating units. Net Medical Labs is a moderate complex CLIA certified lab that specializes in virus and infection testing and diagnostics. The company's mobile fleet of vans provide COVID and flu testing in New Mexico for schools, companies, homeless shelters and nursing homes. The company provides a unique Test-To-Treat program for home and office care that combines both diagnostic and pharmaceutical services that are particularly valuable in rural communities. The lab also serves as a reference lab for physician offices and other facilities that lack services for complex virus diagnostics. Net Medical Xpress provides telemedicine solutions for hospitals, nursing homes, specialty hospitals and other medical facilities. The company maintains a 24/7/365 call center, a team of software developers and telemedicine platforms.
Forward-Looking Statements. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are the company's current expectations about future events and can be identified by terms such as "plans," "expect," "may," "anticipate," "intend," "should be," "will be," "is likely to," "believes," and similar expressions referring to future periods. The company believes any expectations reflected in the forward-looking statements are reasonable but cannot guarantee future results, level of activity, performance or achievements. Actual results may differ materially from those expressed or implied in the forward-looking statements.
SOURCE: Net Medical Xpress Solutions, Inc.
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