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August 1, 2021Eric Topol
August 1, 2021FDA Updates – August 2021
ForeSight sensors monitor brain oxygen saturation and other parameters, DeepCOVID-XR detects COVID-19 on chest radiographs and Digital pathology...
Edwards ForeSight Brain Oxygenation Sensors FDA Cleared to Pair with HemoSphere Monitor
Edwards Lifesciences gained FDA support to integrate the Foresight brain tissue oximetry sensors in conjunction with the HemoSphere monitoring platform. While the clearance is really for a connecting cable, this enables specialists such as anesthesiologists to adequately monitor the oxygen saturation of the brain during a surgical procedure and compare it with hemodynamic parameters on a real-time basis.
Recognizing the relationship between the brain and heart can provide valuable patient insight to support decision-making during a surgical procedure. The addition of the Foresight sensors to Edwards’ most advanced program, HemoSphere, can offer clinicians a wide range of smart hemodynamic management solutions to support and improve patient management and care.
The ForeSight Brain Oxygenation Sensors sensors rely on near-infrared spectroscopy to enter through the scalp and measure the oxygen content on the other side.
An important and genuine characteristic of the HemoSphere system is that the Foresight sensors offer clinicians the capability to predict many cases of sudden blood pressure drops, rendering for a timely intervention during any procedures.(1)
Edwards Lifesciences gained FDA support to integrate the Foresight brain tissue oximetry sensors in conjunction with the HemoSphere monitoring platform. While the clearance is really for a connecting cable, this enables specialists such as anesthesiologists to adequately monitor the oxygen saturation of the brain during a surgical procedure and compare it with hemodynamic parameters on a real-time basis.
Recognizing the relationship between the brain and heart can provide valuable patient insight to support decision-making during a surgical procedure. The addition of the Foresight sensors to Edwards’ most advanced program, HemoSphere, can offer clinicians a wide range of smart hemodynamic management solutions to support and improve patient management and care.
The ForeSight Brain Oxygenation Sensors sensors rely on near-infrared spectroscopy to enter through the scalp and measure the oxygen content on the other side.
An important and genuine characteristic of the HemoSphere system is that the Foresight sensors offer clinicians the capability to predict many cases of sudden blood pressure drops, rendering for a timely intervention during any procedures.(1)
Paige Receives FDA Clearance for the Full Focus™ Viewer for Digital Pathology
The Breast Cancer Diagnostic Developer agenda announced its plans to incorporate its genomic tests with Paige’s artificial-intelligence-powered pathology co-operations to create an innovative digital precision oncology platform.
At the beginning of this year, Paige obtained FDA permission for its Full Focus digital pathology viewer software, enabling researchers and pathologists to analyze and navigate surgical tissue images acquired on all major commercial brands of whole slide imaging scanners.
The artificial intelligence-derived biomarkers will also be applied to promote genomic testing in patients who already have metastasis and support physician’s consideration of therapeutic possibilities. The intention is to provide same-day turnaround in most cases, earlier intervention, preserve limited biopsy or surgical tissue specimens. Another benefit would be to extend key advantages to physicians and their patients with access to testing in countries where tissue send-out is not currently authorized.(2)
The Breast Cancer Diagnostic Developer agenda announced its plans to incorporate its genomic tests with Paige’s artificial-intelligence-powered pathology co-operations to create an innovative digital precision oncology platform.
At the beginning of this year, Paige obtained FDA permission for its Full Focus digital pathology viewer software, enabling researchers and pathologists to analyze and navigate surgical tissue images acquired on all major commercial brands of whole slide imaging scanners.
The artificial intelligence-derived biomarkers will also be applied to promote genomic testing in patients who already have metastasis and support physician’s consideration of therapeutic possibilities. The intention is to provide same-day turnaround in most cases, earlier intervention, preserve limited biopsy or surgical tissue specimens. Another benefit would be to extend key advantages to physicians and their patients with access to testing in countries where tissue send-out is not currently authorized.(2)
DeepCOVID-XR: An Artificial Intelligence Algorithm to Detect COVID-19 on Chest Radiographs.
The Coronavirus Disease (COVID-19) has unique findings on chest imaging, which can help to differentiate it from others conditions. The artificial intelligence uses an algorithm that can recognize characteristic patterns of COVID-19 on chest radiographs to support a probable diagnosis for a more effective triage or infection control within a hospital context.
The DeepCOVID-XR is an organization of convolutional neural networks to recognize COVID-19 on chest radiographs utilizing a real-time polymerase chain reaction as a reference standard. This algorithm was prepared and certified on 14,788 images (4,253 (+) for COVID-19 ) from sites across the Northwestern Memorial Healthcare System from February 2020 to April 2020, then experimented on 2,214 images (1,192 (+) COVID-19) from a single hold-out establishment.
The results of the DeepCOVID-XR when recognizing COVID-19 on chest radiographs had a high effectivity, comparable to a consensus of experienced thoracic radiologists.(3)
The Coronavirus Disease (COVID-19) has unique findings on chest imaging, which can help to differentiate it from others conditions. The artificial intelligence uses an algorithm that can recognize characteristic patterns of COVID-19 on chest radiographs to support a probable diagnosis for a more effective triage or infection control within a hospital context.
The DeepCOVID-XR is an organization of convolutional neural networks to recognize COVID-19 on chest radiographs utilizing a real-time polymerase chain reaction as a reference standard. This algorithm was prepared and certified on 14,788 images (4,253 (+) for COVID-19 ) from sites across the Northwestern Memorial Healthcare System from February 2020 to April 2020, then experimented on 2,214 images (1,192 (+) COVID-19) from a single hold-out establishment.
The results of the DeepCOVID-XR when recognizing COVID-19 on chest radiographs had a high effectivity, comparable to a consensus of experienced thoracic radiologists.(3)