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October 1, 2022IBM
October 2, 2022CLEW, Transenterix, and Ultrasounds.
CLEW predicts respiratory failure, TransEnterix enhances surgeons' performance, are cleared to diagnose cardiovascular complications...
FDA greenlights ICU AI for predicting fatal COVID-19 complications
The FDA has approved CLEW Medical’s remote data monitoring system to recognize COVID-19 patients at risk for respiratory failure. According to previous validation studies, the system could deliver accurate positive alerts predicting impending respiratory failure or hemodynamic instability.
The software gathers extensive data by linking patients’ electronic medical records and vital sign monitors without additional data entry by ICU staff, potentially reducing contact between healthcare providers and COVID-19 patients.(1)
TransEnterix nets FDA clearance for AI vision-guided surge.
TransEnterix, a medical device company, won FDA approval for its digital surgical assistant to improve the minimally invasive procedure. It is recognized as the first machine vision system for robotic surgery. The intelligent surgical unit increases control of the surgeon’s camera during a procedure by electronically identifying specific organs and locations within the field of view.
The “digital surgical assistant” was created to predict what the surgeon wants to see during a procedure and adjust the camera’s focus and zoom accordingly. With this software, the AI unit will collect and interpret visual information from the surgical field. Future plans are expected to improve surgical image analytics in digital laparoscopy and advanced scene recognition during robotic surgical recordings.(2)
To screen COVID-19 patients for heart problems, FDA clears several ultrasounds and AI devices from Philips, Eko, and Caption Health.
Patients with previous cardiovascular diseases are more likely to die from COVID-19. New coronavirus infections can directly debilitate a person’s heart muscle leading to heart failure, arrhythmias, and changes in the ECG. As a result, the FDA has approved devices and algorithms from companies like Philips and Caption Health. With this approval, the software can provide clear guidance to secure the effective and safe use of ultrasound to manage COVID-19- related lung and cardiac complications.
Philips’ Lumify system includes a portable ultrasound solution that provides images over a video call, allowing a different medical team to offer guidance on probe position and other aspects of the procedure over a tablet or smartphone while preserving personal protective equipment. The FDA also authorized Eko for its ECG-based algorithm to identify and treat patients with low ejection fraction, a sign of progressing heart failure, and a significant risk for COVID-19 patients.(3)