Leaning on two decades of experience connecting providers with the patients who need them, Net Medical’s business is unique and growing
ALBUQUERQUE, NM / ACCESSWIRE / April 4, 2022 / Net Medical (OTC PINK:NMXS) announced today it has launched a clinical trial program for medical device manufacturers needing to file an Emergency Use Authorization (EUA) or a 510K clearance with the FDA.
International as well as domestic medical manufacturing companies that want to sell products in the U.S. market are required to file either an EUA or obtain a 510K FDA clearance. An EUA is effective until the circumstances justifying the authorization of the emergency use are terminated by the FDA. At that point, companies must obtain a 510K FDA clearance in order to continue to sell their products.
With the powerful combination of the Net Medical’s proprietary Telemed software, a CLIA authorized laboratory and a highly specialized lab staff, Net Medical is particularly well-equipped to implement this program.
Net Medical’s Telemed software placed third in the FDA’s Designathon contest for COVID-19 reporting in December 2020 out of 731 competing participants including some of the world’s best-known companies. This was an important verification and endorsement of the depth and power of Telemed. https://bit.ly/3K6rOxp
Net Medical CEO Dick Govatski said, “With the deep COVID expertise we have acquired over the past two years, Net Medical has developed a highly complex service essential for medical manufacturers to work through a rigorous process of compliance and regulatory hurdles. Telemed provides highly specific data acquisition, management, maintenance and reporting in English and Spanish. As part of the enforcement policy for medical devices under EUA requirements, manufacturers must follow the reporting (MDR) requirements established in 21 CFR Part 803 (Code of Federal Regulations).
“There are few companies like ours able to handle these requirements because of the power of Telemed that enables running clinical trials requiring extensive processing and reporting of complex interrelated activities. We’ve integrated our telemedicine platform plus a laboratory information system serving the point of care market and the over-thecounter markets. This enables our system to deal with existing and growing Federal regulations and reporting requirements. In addition, our reporting capabilities include a sophisticated Research Use Only (RUO) variant detecting system with the ability to detect multiple variants within a routine COVID test. This is required as part of the trials.
“Net Medical is currently conducting usability studies in English and Spanish as well as a clinical trial for an international COVID test manufacturer. We have additional projects in various stages of development,” Govatski said.
About Net Medical – publicly traded (OTC Pink: NMXS) since 1999.
Net Medical Xpress has two operating units. Net Medical Xpress provides telemedicine solutions for hospitals, nursing homes, specialty hospitals and other medical facilities. The company specializes in teleneurology, teleneurosurgery, telecardiology, teleorthopedics, telewoundcare and telenephrology. We maintain a 24/7/365 call center, software developers, and telemedicine platforms. In additional, Net Medical Labs is a moderate complex CLIA certified lab that specializes in virus testing and diagnostics. The company’s mobile fleet of vans is utilized to provide statewide COVID and FLU testing for schools, companies, homeless shelters, and nursing homes. The lab also serves as a reference lab for physician offices, and other facilities that lack services for complex virus diagnostics.
Forward-Looking Statements. This press release contains forwardlooking 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.