ADA
June 1, 2023
C. MICHAEL GIBSON
June 2, 2023AI & Machine Learning
FDA clears contactless, camera-based systems for monitoring vital signs.
Israeli Startup Nanox Oxehealth has received an FDA De Novo authorization for software that can estimate the pulse, heart, respiratory, and breathing rate from a video camera signal on patients without the need to enter their room and disturb their sleep. This patient monitoring platform is designed for nursing homes and long-term care facilities. The approach is non-invasive and less obstructive than other vitals-monitoring devices.
The agency also granted a de novo clearance to its vital sign software, folded into its more extensive Oxevision service. This management suite also aims to detect falls and injuries automatically, sleep quality, or if the patient leaves its line of vision. In contrast to conventional devices for patient monitoring, such as bed mats, fall monitors, or wearables devices, the Oxehealth Service promises to minimize patient harm and maximize patient recovery.
The goal is to make this Oxehealth vision program available to general hospitals, behavioral health providers, and custodial care settings.
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Nano-X is an Israeli company that has developed a commercial-grade digital X-ray source designed for real-world medical imaging applications. Compact and lighter than conventional X-ray machines.
The Nanox.ARC system is an X-ray bed that generates 2D and 3D images with less radiation and a fraction of conventional images’ price. This Artificial intelligence platform will use x-ray-based algorithms to examine large datasets and merge results with a network of 300 expert radiologists for adequate interpretations to integrate this unique workflow, prioritizing urgent cases.
The program has three categories: Screening and predictive analytics for coronary arterial disease, osteoporosis, stroke prevention, and acute triage for urgent conditions such as pneumothorax, fractures, and pneumonia, including COVID-19. Furthermore, it has other applications, such as routine peer review and quality assurance cases for conditions like lung nodules, tumors, and incidental vertebral compression fractures. Once again, the potential importance of artificial intelligence and machine learning technologies has increased access to safe and effective diagnostics that can be lifesaving for patients.
Artificial Intelligence assists in the detection of colon cancer.
In April 2020, Cosmo Artificial Intelligence, Ltd. won the FDA’s authorization to market the GI Genius device. A device that uses machine learning to help identify potential lesions during endoscopy and suggests clinicians to consider inspecting closer and asses further the area, preventing missing problematic lesions.
Colonoscopy is the standard of care for detecting colon and rectum cancer. Optimizing this screening method is a pressing need, as the National Institute of Health ranks colorectal cancer as the third cause of death by cancer in the United States of America. This disease begins with the growth of polyps and other lesions that progress to cancer.
The GI genius system comprises hardware and software that signals the colonoscope operator through sounds, superimposed short green squares in the image, and locating potential lesions. This system does not intend to diagnose or characterize lesions, only to recognize possible lesions and incentivize clinicians to investigate further specific areas. In clinical studies, the GI Genius system reported a 13% increase in the rate of identifying lab-confirmed adenomas or carcinomas compared to standard colonoscopy. Also, the data showed a higher number of biopsies were performed during the colonoscopy studies, yet no adverse effects associated with the event were observed.