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.
Health Technology, Digital Healthcare
Aspect Imaging | September 25, 2023
Aspect Imaging, a global leader in MRI systems for neonatal patients, has been awarded an Innovative Technology contract by Vizient, the nation's largest provider -driven healthcare performance improvement company. This contract recognizes the unique qualities of Aspect Imaging's Embrace Point of Care Neonatal MRI System and its potential to bring improvements to the healthcare industry. The Embrace Point of Care Neonatal MRI System is designed specifically for the imaging needs of prematureand newborn infants, making it a critical tool in neonatal intensive care units (NICUs).
The Embrace is the world's first FDA-cleared and CE-approved MRI system for neonatal patients. It is designed to be placed directly within NICUs, overcoming the size and risk limitations associated with adult MRI scanners. The system includes features such as a temperature-controlled patient bed and a Whisper Quiet sound profile to meet the specific care needs of neonatal patients. This technology enables safer and more accessible MRI imaging for fragile neonatal patients and provides critical information to the clinical care team.
Chief Commercial Officer at Aspect Imaging, Wendy Slatery, stated,
It is an honor to have the Embrace recognized by the clinical experts at Vizient, as an Innovative Technology, and an exciting opportunity to bring valuable solutions to Vizient customers. We are looking forward to working with Vizient members seeking to expand and elevate neurocritical care of the smallest patients while reducing patient risks and staff time associated with transporting newborns to a traditional MRI. The Embrace MRI gives the neonatal medical team access to information from the life’s first hours and throughout the patient’s time in the NICU, on which critical care decisions will be based.
[Source: Business Wire]
Vizient's provider customer-led councils recommended the Embrace system for an Innovative Technology contract after evaluating its potential to enhance clinical care, patient safety, and healthcare worker safety, or improve business operations in healthcare organizations. The recognition and award of this contract highlight the potential of the Embrace Point of Care Neonatal MRI System to improve neurocritical care for the smallest patients while reducing risks associated with transporting newborns to traditional MRI facilities.
About Aspect Imaging
Aspect Imaging, a pioneering force in the field, stands as the global frontrunner in crafting and advancing compact MR imaging systems tailored for both research and clinical use. Their groundbreaking technology centers on compact, high-performance permanent magnets, introducing transformative MRI solutions to tackle unmet requirements in research and medical contexts. These innovations ensure the delivery of the finest quality images, whether at the benchtop or in point-of-care scenarios.
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.
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.