FDA Updates – August 2023

Published by Daniel at August 1, 2023

- DermaSensor INC helps to detect skin cancer. - Pipeline Flex Embolization Device is designed to divert the flow of aneurysms & reduce thrombi formation. - GARNET filter, bind common infectious agents that trigger uncontrolled sepsis.

The DermaSensor device promises to aid providers in the detection of skin cancer

Skin cancer is a prevalent cancer in the US. Detecting it is a pressing need. The FDA granted breakthrough device designation to The DermaSensor, a device that helps identify suspicious lesions for skin cancer. The DermaSensor is a non-invasive device that works by spectrometry. This device captures the substructure image of the cells and, together with software powered by machine learning, yields in just seconds an analysis of the nature and characteristics of the lesion. This product is already available in Australia and New Zealand and has received FDA accreditation, ensuring prompt review for clearance. .(1)

Surface modification of Pipeline Flex device wins FDA approval

The Pipeline Flex Embolization Device with Shield Technology received FDA approval. This device has a modified surface that reduces clot formation, making it superior to previous versions. Since its release, it has been essential in diverting flow for aneurysms. NYU’s Langone Health Center in New York City was among the first to use the Pipeline Flex device. According to reports, the device’s modifications have reduced thrombi formation and improved performance compared to previous generations. The interventional neuroradiology community and patients across the US have been eagerly awaiting FDA approval of Medtronic’s Pipeline Flex Embolization Device with Shield Technology. (2)

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The BOA Biomedical Group has developed GARNET, a device designed in Boston, Massachusetts, by the Wyss Institute that promises to revolutionize the management of sepsis. The FDA has granted authorization to begin the first clinical trial for its development.

GARNET utilizes fibers coated with the protein FcMBL to filter blood during dialysis, effectively removing infectious agents such as bacteria, parasites, fungi, toxic fragments, and even the SARS-COVID-2 virus. This treatment, which lasts between 3-4 hours, prevents the uncontrolled inflammatory response that causes organ failure in sepsis.

This small group of researchers is pursuing a new approach to sepsis amidst the need to improve care for potentially deadly conditions like sepsis. They believe devices such as GARNET could halt the triggers of uncontrolled inflammatory response in sepsis and potentially benefit patients with infections, including COVID-19(3)