MCRA Assists Net Health in Receiving Breakthrough Device Status

MCRA Assists Net Health in Receiving Breakthrough Device Status

Net Health's Tissue Analytics for Wound Care Granted Breakthrough Device Status by FDA

(PRNewsfoto/Net Health Systems, Inc.)


Net Health Systems, Inc. 

Jun 02, 2022, 08:00 ET​​

 First time an EHR company has received Breakthrough Device Status

PITTSBURGH, June 2, 2022 /PRNewswire/ -- Net Health, a provider of specialty electronic healthcare record (EHR) and predictive analytics software, announced today that Tissue Analytics, the company's AI-powered wound imaging and analysis software, has been granted Breakthrough Device Status by the U.S. Food & Drug Administration (FDA). Tissue Analytics received the rare designation because of its novel diagnostic algorithms. The Company believes the FDA designation represents the first time an EHR company has been granted such designation.

Breakthrough Status indicates that the FDA believes the Company's novel diagnostic Software as a Medical Device (SaMD) could provide more effective treatment or diagnosis of a life-threatening or debilitating condition, such as hospital-acquired pressure injuries (HAPIs), venous and diabetic foot ulcers and other non-healing wounds. Breakthrough Status is not granted solely on the severity of the device's applicable condition. The submission must also meet one of the following criterion: the proposed device represents "breakthrough technology" as defined by the FDA; no other approved or cleared alternatives exist; the device offers significant advantages over existing approved or cleared alternatives; or the device availability is in the patient's best interest.

Net Health's Tissue Analytics Technology Pushes the Boundaries

"Finding ways to help our clients more quickly and accurately identify potentially life-threatening wounds and manage associated costs has been a priority for more than 20 years," said Josh Pickus, CEO of Net Health. "The FDA designation highlights that Net Health is redefining EHRs as much more than  simple documentation systems. Our intelligent AI-driven analytics solutions are pushing the boundaries of EHRs and helping change healthcare outcomes."

Deployed by hundreds of healthcare organizations, including leading hospitals, health networks, and independent wound care clinics, Tissue Analytics' novel diagnostic solution analyzes skin injury images and patient data using machine learning technology. This new level of analysis will allow Tissue Analytics to eventually provide new diagnostic elements as a complement to its current measurement generation imaging software, pending approval of its forthcoming marketing submission.

In granting the Breakthrough Device Status, the FDA recognized that the software could help wound care providers improve care by standardizing the diagnosis and care process of triaging patients with chronic, non-healing wounds with poor healing trajectories. In addition, the Agency noted that the "product will aid clinicians throughout the referral process with additional diagnostic information that can inform the wound care experts' ultimate diagnosis and plan of care for chronic, non-healing wounds."

"A first of its kind advancement like Tissue Analytics' novel imaging functionality will make the clinical workflow for wound care safer, more effective, and ultimately more efficient," said Alex Cadotte, Ph.D., ex-FDA Team Lead and now Director of Software and Digital Health at MCRA, LLC. "The FDA's breakthrough designation acknowledges that Tissue Analytics is a first-of-its-kind device in Wound Care. The designation will also facilitate a collaborative conversation with FDA, which will ultimately be a win for public health."

Learn more about TA's Breakthrough Device Status.

For more information on Tissue Analytics, visit or . 

About Net Health

Net Health's mission is to harness data for human health. 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.

SOURCE Net Health Systems, Inc.