Healthcare Analytics
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.
About Xenex
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.
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Healthcare Analytics
Business Wire | October 04, 2023
AirLife, a leading North American manufacturer and distributor of consumable medical devices for anesthesia and respiratory care formerly known as SunMed, today announced the completion of its acquisition of Avanos Medical, Inc.’s (NYSE: AVNS) (“Avanos”) respiratory health business, including the BALLARD*, MICROCUFF* and endOclear® product lines.
The acquisition adds three complementary brands, the R&D expertise behind them and two manufacturing facilities into AirLife’s growing platform. The transaction advances AirLife’s strategy to enhance its leading portfolio of the most trusted products in anesthesia and respiratory care and serve even more customers as a one-stop source for the highest-quality consumable breathing solutions that support the best patient outcomes.
“We’re thrilled to complete this exciting milestone in AirLife’s evolution as we strengthen our leadership as a premier, completely dedicated consumable breathing products company,”
said Hank Struik, AirLife CEO.
We are especially pleased to welcome the exceptional team that has driven the success of these market leading brands to our company. As some of the most trusted closed suction and endotracheal consumables used to treat patients in critical care, this addition to AirLife unlocks new opportunities to accelerate our growth, serve more healthcare practitioners and drive innovation across our comprehensive portfolio of leading brands.
[Source – Business Wire]
Goodwin Procter LLP is acting as legal counsel to AirLife.
About AirLife
AirLife, formerly known as SunMed and headquartered in Grand Rapids, Michigan with manufacturing and distribution sites in the United States, Mexico, China and Europe, is a leading medical device manufacturer, offering one of the most comprehensive portfolios of consumable anesthesia and respiratory care products. AirLife’s product portfolio spans the continuum of care from first responders to hospitals and home care, with safety, patient comfort and clinical performance in mind. AirLife’s comprehensive portfolio of trusted anesthesia products and respiratory care include premier brands such as Salter Labs®, Ethox Medical™, Ventlab™, Westmed™, AirLife™ and Vital Signs™. Currently, AirLife has over 1 million square feet of manufacturing space, providing comprehensive expertise in all plastics materials and conversion—supported by a world-class Quality Management System. Frazier Healthcare Partners, a leading healthcare investment firm, acquired a majority ownership stake in AirLife in 2021.
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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.
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Health Technology, AI
Aidoc | October 12, 2023
Aidoc, a pioneer in clinical AI technology, has entered into a collaborative partnership with Mayo Clinic Platform to enhance healthcare by facilitating access to Aidoc's AI technology and platform.
Aidoc uses AI to help medical teams in charge of diagnosing, caring for, and treating patients stay in touch with each other. This ensures that essential data is always available to make smart decisions about healthcare interventions and what to do next.
Ed Simcox, Vice President of Solutions at Mayo Clinic Platform, confirmed that Aidoc is well-positioned to deal with several common issues with AI-based healthcare solutions, such as the costs of implementing them only once. By eliminating these barriers, healthcare providers of varying scales can readily implement AI, promoting improved patient outcomes and enhancing the overall care experience.
Elad Walach, Aidoc's CEO, said,
We're excited about Mayo Clinic Platform's vision to transform care at scale. Together we are improving clinical workflows, enhancing patient outcomes and driving the evolution of healthcare through the power of AI.
[Source – Cision PR Newswire]
Mayo Clinic has integrated Aidoc's innovative AI solutions for clinical decision support since 2020. Its collaboration with Mayo Clinic Platform is expanding access to these advanced tools for a broader range of healthcare providers and patients. Aidoc's offerings encompass 13 FDA-cleared image and partner algorithms, facilitating the prioritization of clinical findings. It also has a built-in risk stratification system, a mobile app for real-time notifications in time-sensitive cases, and seamless integration of EHR data, which makes it easier for people from different departments to talk to each other and coordinate care.
Aidoc's aiOS system confronts prevalent issues integrating artificial intelligence within practical healthcare environments. These challenges encompass the management of unstructured data, the efficient utilization of staff resources, the quantification of return on investment, and the resolution of fragmented organizational structures.
About Aidoc
Aidoc is a pioneering force in clinical AI, focusing on aiding and empowering healthcare teams to optimize patient treatment, resulting in improved economic value and clinical outcomes. Aidoc's proprietary aiOS builds the foundation for analyzing and aggregating medical data, enabling care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in more than 1,000 medical centers worldwide, Aidoc has the most FDA clearances (13) in clinical AI, and its AI-based solutions cover 75% of patient populations, enabling physicians to make informed decisions based on real-time data.
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