Designation enables company to market and sell the AI-based capabilities of its industry-leading wound care technologies in European Union
PITTSBURGH, PA – June 29, 2021 – Establishing itself as a global provider of artificial intelligence (AI)-based technology for wound care, Tissue Analytics, a Net Health company, announced today that it had been awarded The European Union (EU) Class I(m) CE Mark. The highly sought-after designation allows the company to market and sell its mobile wound imaging and analytics solution to healthcare organizations based in EU member countries.
The EU strictly regulates medical technologies for member countries, including Germany, Italy and France. Before any medical technology can be sold in the EU, a manufacturer must comply with all applicable EU legislation requirements and affix a CE mark to their product. The CE Mark indicates that a product meets the essential health and safety requirements under the Medical Device Directives (MDD 93/42/EEC).
The announcement makes Net Health ‘s Tissue Analytics the first mobile wound imaging company to achieve a class I(m) certification for the EU. The EU Class I(m) CE Mark is notable as it requires a higher level of regulatory approval – and commitment to obtain the certification – than a class I non-sterile designation. The “m” in the CE Mark indicates that the measurement functionality of Tissue Analytics’ technology has been certified.
The Net Health Tissue Analytics platform is used by thousands of wound care providers in the U.S. to accurately measure wounds, helping clinicians to better treat conditions related to diabetes, poor circulation, burns and other diseases or injuries.
Using a smartphone image, Net Health’s Tissue Analytics deploys its proprietary AI technologies in real-time to automatically detect the boundaries of the injured skin. The image is analyzed by algorithms powered by Net Health’s wound care database, one of the largest in the nation. The combination of leading-edge technology and a robust database provides a powerful tool for healthcare organizations and clinicians seeking to improve patient outcomes and quality of life.
“Net Health’s Tissue Analytics is recognized by the nation’s leading hospitals and wound care clinics as an innovative and responsible developer of AI technologies” says Josh Budman, vice president of Analytics for Net Health and a founder of Tissue Analytics. “This certificate not only allows us to share our technology and insights with EU-based healthcare organizations, it also opens doors to new partnerships and opportunities with businesses that want to tap into our platform and the rich wound care data provided through our specialty EHRs.”
Net Health’s Tissue Analytics provides a unique platform that enables its imaging and other technologies to connect seamlessly to leading wound care electronic health record (EHR) and electronic medical record (EMR) systems, including market leading hospital information systems and Net Health’s Wound Expert solution. This capability makes it one of the most connected and interoperable wound care solutions on the market.
For more information on Net Health’s Tissue Analytics wound care technology, visit https://www.tissue-analytics.com/ and view this recent webinar on the use of analytics in wound care.
About Net Health
Net Health’s mission is to harness data for human health. We offer EHR software and predictive, actionable analytics for medical specialties, including rehab therapy, wound care, home health and hospice, and employee health and occupational medicine. Net Health solutions are trusted in over 23,000 facilities across the continuum of care. Our EHR software enables caregivers and their organizations to engage effectively with patients, streamline documentation, staff efficiently, secure maximum appropriate reimbursement and maintain regulatory compliance. Our unique approach to analytics seamlessly presents insights in clinical and operational workflows to improve care and business performance. Net Health is a portfolio company of The Carlyle Group, Level Equity, and Silversmith Capital Partners. www.nethealth.com.