Xenex | September 11, 2023
United States Food and Drug Administration (USFDA) has issued a De Novo authorization to Xenex Disinfection Services, Inc. (Xenex) for its LightStrikeTM+ device, an advanced high-intensity, broad-spectrum ultraviolet (UV) light robot.
The LightStrike+ devices are designed for microbial reduction on non-critical medical device surfaces in healthcare environments, following manual cleaning and disinfection practices. They are authorized for use in various healthcare settings, including unoccupied operating rooms and hospital rooms. These devices have an impressive track record, with over 1,200 healthcare facilities worldwide employing LightStrike robots for over 37 million cycles.
The new LightStrike+ device, capable of microbial reduction in as little as 2 minutes, represents the culmination of over a decade of knowledge accumulation from healthcare facilities' best practices, supported by 45 peer-reviewed studies demonstrating its safety and effectiveness, a portfolio of 193 patents, and unparalleled technical and epidemiological expertise.
Dr. Mark 'Tuck' Stibich, Xenex's Founder and Chief Scientific Officer, emphasized the long-standing collaboration with healthcare partners spanning more than a decade to enhance patient safety and public health.
As an infectious diseases epidemiologist, Dr. Stibich expressed concern about antibiotic resistance within hospital environments and the potential for FDA authorization to facilitate the broader adoption of the LightStrike+ tool in combating pathogens.
Perilous pathogens persist on surfaces within healthcare facilities, notwithstanding diligent manual cleaning endeavors. The LightStrike+ robot employs a xenon lamp to generate high-intensity pulsed UV light, which effectively diminishes the presence of these pathogens on surfaces and plays a pivotal role in interrupting the transmission chain from one patient or healthcare worker to another. Xenex's FDA authorization is substantiated by comprehensive testing conducted on more than 10,000 samples of vegetative bacteria and Clostridiodes difficile (C. diff) spores.
This authorization establishes a novel medical device product classification, with the LightStrike+ robot being its inaugural and sole product. It is a landmark in the FDA's regulatory framework for UV robots designed to diminish pathogens on non-porous, frequently touched surfaces within healthcare settings.
Furthermore, Xenex's Chief Executive Officer, Morris Miller, acknowledged the challenges hospitals face when evaluating UV technologies, citing the prevalence of unverified and exaggerated claims by some manufacturers. He underscored the significance of FDA authorization in instilling confidence among hospital decision-makers, assuring them of the accuracy and validation of Xenex's claims regarding the LightStrike+ device.
Numerous world-renowned hospitals, such as HonorHealth, Mayo Clinic, MD Anderson Cancer Center, Ochsner Health System, Stanford Health Care, and Texas Health Resources, have integrated LightStrike robots into their comprehensive disinfection strategies.
Xenex is a global leader in pioneering strategies and solutions grounded in UV technology. Its fundamental mission revolves around enabling its partners to safeguard lives and reduce human suffering by eliminating the dangerous microorganisms that cause infections. The company benefits from substantial support from renowned investors, including EW Healthcare Partners, Piper Sandler, Malin Corporation, Battery Ventures, Targeted Technology Fund II, Tectonic Ventures, and RK Ventures.
Beyond Clean | September 07, 2023
Two prominent entities in the sterile processing industry, Crothall Healthcare and Beyond Clean, have entered into a strategic partnership to develop an innovative educational curriculum specially designed for sterile processing professionals serving in hospitals throughout the United States.
This partnership leverages both organizations' collective wealth of knowledge and extensive experience to empower sterile processing professionals with state-of-the-art expertise, enhance patient safety, and elevate the overall benchmarks for sterile processing industry-wide.
Afif Escheik, BA, CHL, CER, CIS, CRCST, CST, Regional Director of Operations at Crothall Healthcare, expressed that this partnership will enhance the company's capacity to provide sterile processing professionals with the educational tools necessary to meet and exceed industry standards, reduce errors, and optimize productivity.
Crothall's track record of achievement in the field of sterile processing has been founded upon its stringent, data-centric methodologies, which have led to a remarkable enhancement in audit compliance of nearly 90%, a substantial reduction in process errors of up to 50%, and significant productivity gains of up to 62%. Through this collaboration, Crothall intends to incorporate these invaluable insights into developing the forthcoming curriculum.
Hank Balch, Founder and President of Beyond Clean, remarked that this partnership will help elevate the standard of sterile processing in the United States, significantly impacting patient safety and quality of service.
The collaborative curriculum is adaptable for various care settings, promoting sustainable, high-value care, enhancing patient safety, and reducing errors across the healthcare organization. This partnership signifies a significant step towards a safer and more efficient future in surgical services.
About Crothall Healthcare
With more than three decades of experience in the healthcare sector, Crothall Healthcare is the foremost provider of patient-centered support services, offering comprehensive solutions tailored to diverse care settings. Its sterile processing services integrate extensive healthcare expertise, clinical rigor, and industry best practices to deliver efficient and highly effective services.
About Beyond Clean
Beyond Clean is a global expert in sterilizing educational content. The company's unwavering commitment to sterile processing motivates it to empower frontline professionals with essential knowledge, education, and steadfast assistance. It also enables them to uphold impeccable standards and ensure the continuous cleanliness of all instruments.
ShiftKey | September 15, 2023
ShiftKey, a leading technological enterprise at the forefront of reshaping the future of workforce engagement, has officially announced its expansion into acute healthcare facilities.
ShiftKey's technology, data resources, and talent marketplace are set to be accessible to acute care facilities in Kansas, Missouri, Tennessee, and Texas. This expansion addresses workforce-related challenges and enhances patients' access to top-tier healthcare services. Furthermore, the technology has already undergone beta testing at acute care facilities in Alabama, Louisiana, Nebraska, New Mexico, South Carolina, and West Virginia.
CEO of ShiftKey, Mike Vitek, characterized the company's foray into the acute care sector as a pivotal step in its platform and business development. He emphasized the organization's vantage point on healthcare staffing challenges and expressed optimism regarding the potential alleviation of strain on acute care facilities and healthcare professionals.
Meanwhile, Brandon Tappan, Chief Revenue Officer at ShiftKey, added that the escalating workforce challenges confronting healthcare facilities have become an annual trend. The departure of nurses from acute care facilities in large numbers underscores the imperative for a novel approach to address staffing needs within institutions serving vulnerable populations. Integrating ShiftKey's technology into acute care facilities represents establishing an independent healthcare staffing solution. This initiative aims to reinvigorate and safeguard this vital industry by enabling individuals to rejoin the workforce on their terms.
ShiftKey is a technological enterprise dedicated to transforming workforce access and integrity. Employing data and a marketplace model, the company facilitates connections between independent licensed professionals and facilities with workforce requirements. It is pivotal in advancing empowered labor, stability, and solutions for professionals, institutions, and beneficiaries. With a platform encompassing 10,000 healthcare facilities and myriad independently licensed professionals, ShiftKey is one of the foremost leaders in strategic workforce solutions, catalyzing a more sustainable, inclusive, and prosperous workforce economy for the years ahead.
ClosedLoop | September 20, 2023
ClosedLoop, a prominent healthcare data science platform, has formally introduced two novel data science solutions.
These solutions, namely, ACO-Predict and Evaluate, are crafted to assist healthcare organizations in the comprehensive analysis, assessment, ongoing surveillance, and enhancement of their programs, with the objectives of minimizing adverse events, enhancing health outcomes, and curtailing expenditures.
ClosedLoop's offering, ACO-Predict, marks the healthcare sector's inaugural no-cost AI-powered solution for population health risk stratification. It harnesses the same algorithms that propelled ClosedLoop to garner fame in the 2021 CMS AI Challenge and earned the Best in KLAS Healthcare AI ranking for 2022 and 2023. When integrated with the updated Beneficiary Claims Data API data feeds from the Centers for Medicare and Medicaid Services, the product furnishes Medicare Accountable Care Organizations with a turnkey risk stratification tool for Complex Care Management programs, all free of charge.
Meanwhile, the company's second product, ClosedLoop Evaluate, is a SaaS solution designed to evaluate and continuously monitor the efficacy of intricate population health initiatives over extended durations. Quantifying the impact and ROI of Population Health programs has presented significant challenges. Organizations often need to resort to imprecise pre- and post-assessments or enlist costly consulting firms for one-off outcome research studies to understand the actual effects of their programs.
ClosedLoop’s solutions aim to improve healthcare organizations' outcomes and offer essential patient support.
Jennifer Zbell, VP of Clinical Analytics at Healthfirst, stated,
ClosedLoop provided the quantitative evidence we needed to increase investment in successful programs." She added, "Evaluate gives us the confidence to examine our programs across the board so we can better see what's working, when it's working, and who it's working for.
[Source – Business Wire]
ClosedLoop Evaluate represents a pioneering industry solution that not only supplants these studies with software-driven evaluations but also facilitates the ongoing assessment of program impact amid evolving programs and populations.
Andrew Eye, Co-Founder and CEO of ClosedLoop concluded that success in value-based care hinges on two key aspects: accurate prediction and effective intervention. ACO-Predict delivers AI-powered prediction capabilities to all medicare patients nationwide at no cost, ensuring access to necessary assistance regardless of location or ACO resources.
ClosedLoop is a dedicated data science platform tailored to the healthcare sector, simplifying the integration of AI technology to enhance outcomes and curtail expenses. Uniquely designed for the healthcare domain, the company merges an intuitive, all-encompassing ML platform with an extensive repository of healthcare-specific functionalities and model templates. Customers leverage ClosedLoop's Explainable AI capabilities to facilitate clinical excellence, streamline operational processes, navigate value-based contracts, and bolster revenue generation in the healthcare industry.