DALLAS, February 21, 2023 (Newswire.com) - Spectral MD Holdings, Ltd. (AIM: SMD), a predictive analytics company with proprietary AI algorithms and optical technology for faster and more accurate treatment decisions in wound care, announces the initiation of its EU clinical study to support the development and regulatory submission of its Diabetic Foot Ulcer (DFU) application for the Company's DeepView™ technology.

The Company has partnered with the Royal College of Surgeons in Ireland's (RCSI) Skin Wounds and Trauma (SWaT) Research Centre, Prof. Zena Moore, Director; and Prof. Declan Patton, Deputy Director, at RCSI University of Medicine and Health Sciences, to execute the clinical study with Prof. John McDermott (Chief Clinical Investigator) and Prof. Seamus Sreenan (Sub Investigator), both of Connolly Hospital, and RCSI in Dublin, Ireland.

The EU Wound Assessment Using Spectral Imaging clinical study will collect data from DFU patients monitored up to 12 weeks. The intention of the clinical study is to further develop the DeepView AI®-DFU algorithm and support the  Company's 2023 regulatory submissions for UK CA, US FDA, and EU CE Mark. 

Chronic wounds, such as DFU, affect 9.1 to 26.1 million patients globally each year and are the most frequently recognized, complex and costly symptom of diabetes. Globally, 70% of DFUs recur within three years, representing a significant health and economic burden to both patients and hospital systems. Additionally, undiagnosed, misdiagnosed, or untreated DFUs commonly lead to limb amputation and poor patient outcomes. 

There is currently no diagnostic tool available for early wound healing diagnosis, with physicians required to wait 30 days to designate a DFU as non-healing before using advanced wound care therapies. Early and accurate diagnosis of non-healing DFUs would considerably improve patient quality of life and DFU healing rates. The Company announced in January 2023 interim results for DeepView AI®-DFU's day-one prediction of 86% diagnostic accuracy of a 50% DFU size reduction by week four from five clinical study sites in the U.S., and this EU clinical study data will enhance its clinical database and strengthen the regulatory and clinical pathways.  

Prof. Zena Moore and Prof. Declan Patton of the RCSI SWaT Research Centre jointly commented: "With our clinical partners we are committed to better wound care diagnostics and treatment for patients. This study will ensure we continue to be at the cutting edge of clinical wound care research that makes a difference to people with non-healing ulcers. Working with Spectral MD also enhances our place at the forefront of medical device research and translation for everyday wound care practice."

Wensheng Fan, Chief Executive Officer of Spectral MD, stated: "The initiation of the EU study is an important milestone for the Company. We are delighted by this industry-academic partnership led by a group of eminent clinicians and clinical researchers, which we see as a significant industry-wide endorsement for DeepView™. Data collected from this collaboration will strengthen the predictive capability of the DeepView™ technology for early-stage wound assessment."

Prof. Fergal O'Brien, Deputy Vice-Chancellor for Research and Innovation at RCSI, commented: "By bringing together the research expertise of the SWaT Research Centre at RCSI with the advanced technological capabilities of Spectral MD, this study is driving forward wound care technology development to address a significant unmet need by improving diagnostic imaging and quantitative diagnosis and ultimately patient outcomes."

For further information please contact: [email protected]

About Spectral MD:                                                                                   

We are a dedicated team of forward-thinkers striving to revolutionize the management of wound care by "Seeing the Unknown" ® with our DeepView^® Wound Imaging System.

www.spectralmd.com

[email protected] 

About RCSI University of Medicine and Health Sciences

RCSI University of Medicine and Health Sciences is a world-leading university for Good Health and Well-being. Ranked in the world top 50 for its contribution to UN Sustainable Development Goal 3 in the Times Higher Education Impact Rankings 2022, it is exclusively focused on education and research to drive improvements in human health worldwide.

RCSI is an international not-for-profit university, headquartered in Dublin. It is among the top 250 universities worldwide in the World University Rankings (2023). RCSI has been awarded Athena Swan Bronze accreditation for positive gender practice in higher education.

Visit the RCSI MyHealth Expert Directory to find the details of our experts across a range of healthcare issues and concerns. Recognising their responsibility to share their knowledge and discoveries to empower people with information that leads them to better health, these clinicians and researchers are willing to engage with the media in their area of expertise. 

Glidewell Restorative CT\u2122 Integrated Solution

NEWPORT BEACH, Calif., February 21, 2023 (Newswire.com) - Attendees of the 38th Annual LMT Lab Day Chicago can visit Glidewell representatives at Booth L-13, East Tower to learn about the all-new Glidewell Restorative CT™ Integrated Solution, developed and used by the California-based laboratory to digitize physical impressions and expedite digital crown design without the need for traditional plaster models.

Known for its mission to improve patient access to dental care by way of technological innovations, Glidewell has worked for years to develop a micro-CT-based solution that can help to eliminate errors and inefficiencies associated with analog model work.

"Most remakes originate in the plaster room," said Jim Glidewell, the company's founder and president, "resulting in lost chair time for the dentist and inconvenience for the patient. The lab is harmed not just in terms of productivity, but reputation. It's been a headache for my entire 55 years in the business."

The advent of computed tomography (CT) scanning led him to wonder if the technology could be used to scan a physical impression. When none of the CT scanners on the market proved sufficient, the technology pioneer challenged his engineers to develop an in-house machine that not only met ISO standards for accuracy of crown fit but was also capable of 24/7 high-volume lab production.

The Glidewell Restorative CT solution uses X-ray technology to overcome an optical scanner's line-of-sight limitation, capturing undercuts and other concavities for greater dimensional accuracy. The subsequent "meshing" of scan layers takes place seamlessly in the cloud while the next impression is scanned, serving to maximize overall throughput.

"Even though 50% of our cases are submitted digitally, 70% of our customers still send us physical impressions," said Mr. Glidewell. "Scanning the original impression has proven far more advantageous than scanning a stone model—as I believe most lab owners would agree."

Once a scan is finalized, the integrated software provides virtual models and automatic crown designs derived from proprietary artificial intelligence trained from 20 million actual cases. Glidewell claims an 81% acceptance rate of automatic design proposals, requiring no refinement from a CAD operator and boosting daily design output by as much as 300%.

The streamlined process takes just minutes, after which design files can be downloaded from the cloud and milled anywhere.

"By eliminating the plaster process, we've reduced costs, accelerated turnaround, and increased the consistency of our restorations. It's been a true game changer for production, and I encourage fellow labs of any significant case volume to see if it can do the same for them."

The Glidewell Restorative CT solution was initially unveiled at the January 2023 NADL Vision 21 meeting in a presentation by Mr. Glidewell. For more information, contact Monica Silva at (949) 524-7510.

sam\u00ae Sport

TRUMBULL, Conn., February 21, 2023 (Newswire.com) - When tennis season begins, many professional and collegiate players will turn to pain medication for relief from lateral epicondylitis, colloquially referred to as tennis elbow. Those with advanced symptoms often believe that surgery is their only option—a misconception that ZetrOZ Systems dispels with the sustained acoustic medicine (sam®) Sport pain relief device, a wearable, drug-free, noninvasive alternative to medication and surgery.

ZetrOZ Systems' sam® technology provides long-duration, low-intensity ultrasound therapy, clinically validated in more than 30 studies and in the successful treatment of more than 500,000 patients. Both patients and healthcare providers report 90%-plus satisfaction rates with sam® treatment for sport-related injuries.

Lateral epicondylitis is a painful condition in the tendon that can develop in response to repetitive motions of the wrist and arm. The pain can extend from the elbow into the forearm and wrist, and the severity can range from mild to debilitating. ZetrOZ Systems' sam® injury healing device not only reduces these levels of pain but accelerates the tendon's natural healing process by minimizing inflammation, increasing circulation, and facilitating the removal of waste products like lactic acid from the site of the musculoskeletal injury.

The sam® Sport pain relief ultrasound device is the only FDA-cleared multi-hour ultrasound treatment that is approved for home use. Despite running on battery power, a sam® device can produce up to 18,000 joules when two crystals are used, in contrast to a traditional wall-socket ultrasound at 2,000 to 4,000 joules. 

"The portability of sam® Sport makes four hours of daily use easy to fit into one's day—the device is simple to apply and use, and flexible enough that it can be worn while multitasking most activities," says Dr. George Lewis, founder and CEO of ZetrOZ. "We are pleased to offer an accessible, pain-free road to recovery for athletes and other patients who are searching for alternative options to surgery and medication."

The ZetrOZ sam® technology was developed with funding grants from several U.S. government agencies and is built on proprietary medical technology of 46 patents. To learn more, visit zetroz.com.

About ZetrOZ Systems

ZetrOZ Systems is leading healing innovation in sports medicine, developing wearable bioelectronic devices for the delivery of sustained acoustic medicine (sam®). Researched and funded by the federal government, ZetrOZ is built on proprietary medical technology of +46 patents. The exclusive manufacturer and developer of the sam® product line is designed for the treatment of acute and chronic musculoskeletal conditions.

MOORESVILLE, N.C., February 21, 2023 (Newswire.com) - The Hemp Doctor is proud to announce Platinum Sponsorship of the 2023 High Times Hemp Cup. During a time of shutdowns, High Times re-invented their classic Cannabis Cup to include a People's Choice Edition to allow everyone at home to participate. 

This competition is unlike any other in the industry in that it allows individuals who use the products to determine what products are best. Whether consumers choose to partake in the judging or not, the results are as democratic and unbiased as possible. 

Judging kits went on sale on Friday, Feb. 10 and are available for purchase while supplies last. Kits are available for consumers to choose which categories they'd like to sample, including psychoactive and non-psychoactive hemp-derived products. More than 200 kits of each category are available for sale for the 2023 Hemp Cup. 

The 2023 High Times Hemp Cup is the third-ever competition of its kind that's open to the nationwide public. The goal of this competition is to recognize the best hemp-derived products in the USA. The Hemp Cup is open to a wide range of categories, including edibles, vapes, flower and pre-rolls, capsules, and tinctures. There will be a variety of hemp-derived, legal psychoactive products sampled, including Delta 8, Delta 10, HHC, THCV, and more. A range of non-psychoactive CBD products will be available for sampling as well.

In addition to sponsoring the competition, The Hemp Doctor is submitting their best-performing products for judging. These three CBD entries include the Full Spectrum Gummy in Non-psychoactive Hemp-Derived Edibles, The lemon-flavored full-spectrum 2800mh High Octane Tincture in the Non-psychoactive Hemp-Derived Tinctures category, and the one gram vape cartridge in the Hemp-Derived Concentrates and Vape Pens category. 

The Hemp Doctor is also submitting four products in the legal psychoactive categories. For the Legal Psychoactive Flower and Pre-Rolls, they are submitting the Delta 8 Happy Daze and Delta 8 Witches Brew prerolls. Both of these prerolls will be 1.75 grams. In the Legal Psychoactive Concentrates and Vape Pens, they're submitting three entries: two surprise flavors of the 3-gram disposable vapes and a surprise of the 2-gram vape cart. In the Legal Psychoactive Edibles, The Hemp Doctor is submitting three samples of the THC Blended Gummies. And three sample products will also be provided for the Legal Psychoactive Edible/Non-Gummy category as well. 

Judging kits are on sale now at hthempcup.com and all judging is due to be completed by April 2, 2023. On April 16, 2023, High Times will be holding an award show to announce best in class for each category. 

The Hemp Doctor, a North Carolina-based American company, is passionate about how hemp can change lives. Selling only organically grown products that are made in the USA, The Hemp Doctor was founded by Robert Shade. He was inspired when he saw how hemp helped his family recover from a catastrophic car accident and wanted to create a place for more people to find their hope and recovery. 

BALTIMORE, February 21, 2023 (Newswire.com) - Over 59 million patient records were breached in 2022 according to a new report released today, the Protenus Breach Barometer®. Published by Protenus, a healthcare compliance analytics company that protects patient data for the nation's leading health systems, the annual report is the industry's definitive source for health data breach reporting review. 

In 2022, the healthcare industry remained altered by the effects of the pandemic and The Great Resignation, resulting in nursing turnover, ongoing staffing shortages, increased remote and hybrid work, financial pressures, and increased "mega mergers". Cybercriminals have long targeted healthcare's vulnerabilities, and the continuing industry disruption created opportunities for exploitation. There were 956 reported health data breaches in 2022, up 5% from 905 reported in 2021, however the number of patient records breached increased 18% year over year to nearly 60 million.

Download the full report here.

The Breach Barometer also notes that insiders continue to be a risk, accounting for one in 10 healthcare data breaches. Insider behavior often gives outsiders a foothold for improper access to patient data and may have provided an entryway for the many hacking incidents behind the majority of 2022 breaches. Records breached by insider error alone skyrocketed 141% last year. 

Nick Culbertson, CEO and Co-Founder of Protenus, stressed the importance of reducing insider risk, "A preventive, proactive approach is the only way to mitigate the significant breach risk insiders pose. Healthcare organizations need to look at whether they're truly able to monitor every access to patient data every day. The financial cost of a breach is staggering, but the reputational damage and impact on patient safety will have serious repercussions on affected healthcare organizations and their patients for years to come."

Incidents included in the analyses for this report were compiled and analyzed by DataBreaches.net, with additional research and analyses by Protenus.

Protenus' AI-driven patient privacy monitoring and drug diversion surveillance solutions help hospitals and health systems ensure health data is safe and being used appropriately. Founded in 2014, Protenus was awarded 2023 Best in KLAS for both patient privacy monitoring and drug diversion surveillance solutions, named one of 2021 CBInsights Digital Health 150, is a three-time winner of Forbes' America's Best Startup Employers, and was named one of The Best Places to Work in Healthcare by Modern Healthcare and one of the Best Places to Work in Baltimore by the Baltimore Business Journal and the Baltimore Sun. 

About Protenus

Protenus harnesses the power of AI to provide healthcare organizations with scalable risk-reduction solutions that drive the safest patient outcomes while protecting the reputation of the organizations. We are committed to innovation, determined to reduce risk, and focused on supporting our community of employees, customers, and ultimately, patients. Empowering healthcare to eliminate risk is at the heart of all we do. Learn more at Protenus.com and on Twitter @Protenus.