New Products and Industry News

Net Health’s Tissue Analytics First to Receive the EU Class I(m) CE Mark For Mobile Wound Care Imaging and Analytics

Designation enables company to market and sell the AI-based capabilities of its industry-leading wound care technologies in the European Union

Establishing itself as a global provider of artificial intelligence (AI)-based technology for wound care, Tissue Analytics, a Net Health company, has announced that it has 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 health care 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 nonsterile 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 United States to measure wounds accurately, 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 health care 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,” said 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 health care 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 systems, including Cerner, Epic and Net Health’s Wound Expert solution. This capability makes it one of the most connected and interoperable wound care solutions on the market.

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. EHR software enables caregivers and their organizations to engage effectively with patients, streamline documentation, staff efficiently, secure maximum appropriate reimbursement, and maintain regulatory compliance. This 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. For more information, go to www.nethealth.com.

New Claims Submission Guidelines for SnapshotNIR

Specifically designed CPT Codes 0640T–0642T announced

Kent Imaging Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has released claims submission guidelines for CPT Codes 0640T–0642T in the guidance document CR Transmittal Number: R10860CP referenced in the MLN Matters MM12289, published June 30, 2021

Kent notes the codes 0640T and 0642T have been classified as reimbursable on a case-by-case basis per Medicare Administrative Contractor (MAC) discretion. The code 0641T was assigned to the APC grouper code 5732 for utilization by outpatient facilities. Kent Imaging says it will submit an APC code Revision Request and anticipates further information regarding this request by October 2021. The company will also be communicating directly with the individual MACs outlining the positive clinical and financial implications of the SnapshotNIR.

The CPT codes listed above must be utilized to report the use of SnapshotNIR, according to the company. The National Correct Coding Initiative states that CPT/HCPS coding must reflect the most accurate description of the services provided. Since the codes 0640T–0642T were specifically designed to reflect the usage of SnapshotNIR, Kent notes it will no longer be appropriate to utilize Unlisted or Miscellaneous CPT codes for dates of service after June 30, 2021.

CPT Codes 0640T-0642T are a family of Category III codes specific to SnapshotNIR for noncontact, near-infrared (NIR) spectroscopy studies of flap or wound for image acquisition, interpretation, and reporting.

About Kent Imaging

Kent Imaging’s mission is to help improve outcomes and reduce complications in as many patients as possible. Kent Imaging, located in Calgary, Alberta, Canada, is a leading innovator of medical technology that designs, manufactures, and markets imaging technology for limb preservation and surgical care. Kent holds multiple patents in oxygen imaging technology and continues to provide innovative and advanced diagnostic imaging solutions to aid health care systems nationally and internationally. The focus at Kent is how innovative medical technologies improve the health and well-being of patients. Understanding oxygenation in the proximal microvasculature is key to understanding potential tissue survival and healing. To learn more, go to https://www.kentimaging.com.

The Carlson Plastic-Neutral Journey Begins

Carlson joins a growing movement of brands committed to making an immediate and positive environmental impact

Carlson, a global nutritional supplement company, announced that it will be expanding its sustainability efforts and starting on its journey toward becoming plastic-neutral by joining IMPACT COLLECTIVE, a group of forward-thinking brands committed to making an immediate and positive environmental impact through the reduction of their carbon, plastic, water, and energy footprints. This initiative is managed and administered by GreenPrint, a global environmental technology company.

“At Carlson, we’re as committed to the environment as we are to the high quality of our products,” said President Carilyn Anderson. “Since we imported our first omega-3 fish oils from Norway in the early 1980s, we have been dedicated to working with low-impact fisheries using traditional, sustainable methods–and now we’re taking steps toward going plastic-neutral by removing proportionate amounts of plastic from our waterways.”

IMPACT COLLECTIVE offers members sustainability solutions to improve the environmental impact of their products. With their patented technology, they calculate members’ carbon, plastic, energy, and/or water consumption and offset it through investments in certified projects. IMPACT COLLECTIVE members can be recognized through IMPACT seals that appear on product packaging.

“As we continue to partner with companies within the CPG space, we are proud to include Carlson as an IMPACT COLLECTIVE member,” said Pete Davis, founder and CEO of GreenPrint. “Together, we are empowered to be responsible stewards of our planet and are working to drive the industry to become more sustainable, one step at a time.”

About Carlson Labs

Carlson Labs has produced pure, quality, award-winning vitamins, minerals, fish oils, and other nutritional supplements. The company began with a single vitamin E product in founder Susan Carlson’s small Chicago apartment and quickly grew to offer the most complete line of all-natural vitamin E supplements in the world. Today, the next generation of Carlson Labs leads the company—daughters Carilyn Anderson and Kirsten Carlson—and the innovations continue. Carlson Labs now offers more than 200 unique products designed with your family’s unique nutritional needs in mind. For more information, go to https://carlsonlabs.com.

Practice EHR Launches Enterprise Practice Management Software

Practice EHR recently announced the launch of its enterprise practice management solution, Practice
EHR Enterprise

The company notes its software solution provides robust functionality that can streamline the medical billing workflow and improve financial performance and productivity for hospitals, medical practices, and medical billing companies. The platform provides a powerful set of enterprise features to meet the unique performance, reliability, and scalability demands of enterprise-level organizations. The system can support tens of thousands of users, hundreds of terabytes of data, and scales to support any size health care organization.

About Practice EHR

Practice EHR is a cloud-based and specialty-specific EHR and practice management solution that supports care delivery and drives a healthy practice. The company offers a specialty-specific workflow and simplification of things like documentation, billing, and practice management. We deliver an intuitive, simple, and cost-effective solution and provide customer support at no additional cost. For more information, go to https://www.practiceehr.com.

The Wound Care Learning Network Interviews Tyler Palmer

Vice President of Marketing and Business Development at Essity discusses the company and its #Wound_Warriors campaign

What does the name Essity mean, and how is it important to the company’s brand and mission?

The name Essity stems from the words “essentials” and “necessities.” Hygiene and health are the essence of well-being. Better hygiene and health are necessities for better lives, and our products and solutions play an essential role in improving well-being. Essity’s mission is to sustainably develop, produce, market, and sell value-added hygiene and health products and services.

Essity is a leading supplier of wound care, compression therapy, orthopedics, and incontinence products and the manufacturer of brands such as Cutimed, JOBST, Leukoplast, Delta-Cast, Actimove, and TENA. Our Essity Health and Medical Solutions business in North America was bolstered by our 2017 acquisition of BSN Medical, a leading medical solutions company.

Through its #Wound_Warriors campaign, Essity is working to further the World Health Organization’s mission to help prevent antimicrobial resistance (AMR) in regard to fighting infections. This involves preventing the development of bacteria that develop resistance after a patient is treated with antimicrobial drugs.

Why do you feel so passionately about this campaign and what encouraged Essity to be involved?

It is estimated that unless action is taken, the burden of deaths from resistant bacteria could increase to 10 million lives per year by 2050.¹ We found this staggering. As a key provider of wound care solutions, we want to join the fight against AMR.

The objective of Essity’s #Wound_Warriors campaign is to make health care professionals aware of the role of wound management in the global fight against AMR. Our goal is to recruit more wound warriors amongst our customers, partners, and stakeholders, educate them about AMR in wound care, and emphasize that we can support them in fighting AMR.

How does a clinician become a wound warrior? What are the right tools/methods to prevent infection and manage the wound, especially when trying to avoid AMR?

It is important to emphasize that appropriate wound care for infection prevention, and management can play a powerful role in the fight against AMR.

At least 30% of antibiotic courses prescribed in the outpatient setting are unnecessary, which leads to increasing AMR.² To be truly effective in the prevention of AMR, action must be taken at every level of wound care, from wound care specialists to wound care nurses.

Wound care specialists and nurses alike can become wound warriors by using effective, nonmedicated dressing pads, swabs, round swabs, ribbon gauzes, and gels to treat hard-to-heal wounds, remove bacteria, and help promote the natural wound healing process.

How does Essity plan to fight AMR? What products do you have available that can help fight and manage infections in a patient?

Cutimed Sorbact products, manufactured by Essity, are nonmedicated, antimicrobial wound care products for the management of clean, colonized, contaminated, and infected wounds. Instead of using chemically active agents, Cutimed Sorbact technology uses a physical mode of action to effectively bind and inactivate hydrophobic pathogenic bacteria and fungi and ultimately remove them from the wound. With every dressing change, bacteria are removed, helping to promote the natural wound healing process.

Cutimed Sorbact does not kill bacteria and therefore may help reduce the release of endotoxins from dead bacteria cells, which can inhibit the natural wound healing process. It can be used wherever microbes impair or hinder a wound’s healing and is available in dressing pads, swabs, round swabs, ribbon gauzes, and a gel to meet almost any wound care need.

As a nonmedicated wound care product, treatment with Cutimed Sorbact technology has not been linked to the risk of developing antibacterial-resistant microbes. Importantly, Cutimed Sorbact technology and products are effective against hydrophobic fungi and bacteria—including antibiotic-resistant strains of bacteria like methicillin-resistant Staphylococcus aureus.

With Essity’s effort to fight AMR by offering free AMR kits to clinicians, how should a clinician go about attaining one of these free kits?

Clinicians and wound care specialists can visit our #Wound_Warriors homepage to claim their free antimicrobial resistant kit, which contains a free sample of Cutimed Sorbact and educational literature. In addition to the AMR kits, we encourage them to join the conversation on social media using the hashtag #Wound_Warriors. If they have any questions, we encourage them to please contact us by email at HMS.Orders@essity.com or directly at 1-800-537-1063 and select option 1.

Is there anything else you believe the audience should know regarding the #Wound_Warrior campaign or Essity as a leader in addressing AMR?

In 2015, the World Health Organization identified AMR as one of the world’s most pressing drug resistance trends and launched a Global Action Plan on AMR.³ Through the #Wound_Warriors campaign, Essity is furthering this mission and encouraging wound care specialists and nurses to join in the fight against AMR. As mentioned earlier, Essity offers a comprehensive range of wound care products through its brands, Cutimed and Leukoplast, which effectively prevent and manage infection with no known risk of further contributing to antimicrobial resistance.

References

1. Review on antimicrobial resistance. AMR-Review. Accessed April 8, 2021. https://amr-review.org/

2. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA. 2016 3;315(17):1864–1873. doi:10.1001/jama.2016.4151

3. World Health Organization. Global Action plan on antimicrobial resistance. WHO. Published May 2015. Accessed April 8, 2021. https://www.who.int/antimicrobial-resistance/global-action-plan/en/

The opinions and statements expressed herein are specific to the respective authors and not necessarily those of Wound Management & Prevention or HMP Global.

This article was not subject to the Wound Management & Prevention peer-review process.