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July 1, 2023
Article of the Month – July 2023
July 1, 2023FDA Updates – July 2023
FDA approves wireless braces that use brainwaves to improve hand function in stroke patients.
After experiencing a stroke, many patients may suffer from motor dysfunction, particularly in their upper limbs, which can significantly impact their daily lives. To address this, the FDA has granted market authorization to the “IpsiHand Upper Extremity Rehabilitation System.” This cutting-edge stroke rehabilitation technique wirelessly transmits brainwaves to a tablet, allowing a connected robotic device to improve hand movement in the affected arm.
The patient wears an electroencephalography (ECG) cap, which records brain activity from the unaffected side of the brain. This data is then translated and sent to a robotic brace placed over the forearm, wrist, and fingers. As patients intentionally move their arms, the brace follows their movements to help improve their motor function.(1)
FDA Authorizes First Machine Learning-Based Screening Device to Identify Biomarkers That May Indicate COVID-19 Infection
The FDA has approved a new device called the Tiger Tech COVID monitor for screening patients for COVID-19. The device, an armband placed on the left arm, uses a light sensor to detect blood flow. Within just three minutes, it can measure pulse rate and other factors to determine if blood is clotting more quickly than expected, a symptom associated with coronavirus infection.
This new technology, when used in combination with temperature assessments, can help identify infected patients and reduce the spread of COVID-19 in public settings. Results are displayed using colored lights, indicating specific biomarkers or inconclusive results. The FDA reports that Tiger Tech’s COVID monitor was able to identify positive cases in healthcare settings with an accuracy rate of 98.6% and 94.5% of the time.(2)
The FDA has approved a new device called the Tiger Tech COVID monitor for screening patients for COVID-19. The device, an armband placed on the left arm, uses a light sensor to detect blood flow. Within just three minutes, it can measure pulse rate and other factors to determine if blood is clotting more quickly than expected, a symptom associated with coronavirus infection.
This new technology, when used in combination with temperature assessments, can help identify infected patients and reduce the spread of COVID-19 in public settings. Results are displayed using colored lights, indicating specific biomarkers or inconclusive results. The FDA reports that Tiger Tech’s COVID monitor was able to identify positive cases in healthcare settings with an accuracy rate of 98.6% and 94.5% of the time.(2)
ActivSight, a device that enhances intraoperative surgical vision, receives clearance from the FDA
Founded in 2017 by Dr. Peter Kim, MD, Ph.D., ActivSurgical is a company dedicated to ensuring the best possible surgical care for everyone. The company’s latest development, ActivSight, was approved by the FDA in April 2021. ActivSight is a device that helps improve surgical vision and reduce surgical errors, which are a leading cause of preventable medical errors and global healthcare costs.
ActivSight consists of a hardware component that fits between the endoscope and the camera and a software platform called ActivInsights that allows surgeons to assess tissue blood flow in real time without using dyes. These developments work together within a platform called ActivEdge, which uses machine learning and artificial intelligence to enhance the laparoscopic surgical experience.
Thirteen major healthcare systems worldwide have already joined and are eagerly anticipating the technology’s incorporation into their surgical practices in the second half of 2021. The launch of this innovative technology promises to revolutionize the future of surgery and improve patient outcomes.(3)