June 2, 2022 | Net Health

3 Minute Read

Tissue Analytics Imaging, Analysis Solution Earns FDA Breakthrough Status, an EHR First

The days of EHRs being viewed as simple documentation systems are largely over. From improving communication and workflows to offering more actionable metrics for providers and directors, EHRs have increasingly evolved through the years.

Yet to this point, few things have shattered the healthcare industry’s preconceptions of what an EHR company can do more than the latest tool developed by Tissue Analytics.

Tissue Analytics recently developed an artificial intelligence (AI)-powered wound imaging and analysis solution that employs novel diagnostic algorithms. In a first for EHR companies in the U.S., this tool was recently granted Breakthrough Device Status from the Food & Drug Administration (FDA).

What is Breakthrough Status?

The Breakthrough Devices Program, which provided the status to Tissue Analytics, is a voluntary FDA program for medical devices that enable providers to more effectively diagnose and/or treat life-threatening or irreversibly debilitating diseases or conditions.

The entire point of the program, according to the FDA, is to provide patients and healthcare providers with timely access to these devices by speeding up their development, assessment and review while still preserving the statutory standards of the FDA.

The status also indicates the device in question – in this case, Tissue Analytics’ wound imaging and analysis solution – meets at least one of the following criteria:

  • It represents breakthrough technology,
  • No approved or cleared alternatives exist,
  • It offers significant advantages over existing approved or cleared alternatives, or
  • Device availability is in the best interest of patients.

Why is Breakthrough Status Important?

Tissue Analytics received this rare designation because of its novel diagnostic algorithms that it hopes to bring to the market in the future.

This solution — easily deployed on a smartphone or tablet — will help wound care providers improve wound care by standardizing the diagnosis and care process for patients suffering from chronic, non-healing wounds.  

Tissue Analytics has been helping wound care providers more accurately measure wounds since 2014. We plan to continue to help clinicians across the continuum of care improve the accuracy and consistency of wound care documentation with this new technology once it is formally approved. 

This is not our first planned deployment of artificial intelligence in wound care. Our Risk of Amputation Indicator, launched last year, is a predictive analytics tool that informs clinicians of the likelihood that a wound could lead to an amputation by highlighting obstacles to recovery. In addition, the Wound Healing Velocity Indicator informs clinicians of the likelihood that a specific patient’s wound will heal within four, eight, 12, or 16 weeks.

This indicator, built in to the Net Health Wound Care software, offers a real-time snapshot of a wound’s likelihood of healing based on an analysis of millions of wound care episodes and factors in hundreds of parameters that affect healing time.

A Word About Cost

We’re excited about getting technology to consistently document wounds in the hands of more providers. Those of us in wound care see first-hand the challenges of wound care and how it impacts patients and their loved ones.

Pressure injuries alone impact more than 2.5 million Americans1 at a cost of more than $26 billion a year2. And we are all constantly searching for ways to give our clinician users more information about these conditions.

For the Medicare population alone, the annual cost burden for care of diabetic foot disease is an estimated $18.7 billion for Medicare recipients.3 

Through technological innovation and partnership with dedicated wound care professionals, we hope to turn these trends around. We are honored to have received the Breakthrough Designation from the FDA and are excited to continue developing this technology.

Looking for more information?

Read our news release.

You can find out more about the FDA’s Breakthrough Status designation here

Learn about Tissue Analytics platform here


1Sullivan N. Chapter 21. Preventing in-facility pressure ulcers. In: Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices. Rockville, MD: Agency for Healthcare Research and Quality; March 2013.

2Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019;16(3):634-640. doi:10.1111/iwj.13071.

3Nussbaum SR, Carter MJ, Cartwright, D. et al. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. 2018 Jan;21(1):27-32. doi: 10.1016/j.jval.2017.07.007.

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