Search Tag: FDA clearance
2024 26 Mar
Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies, the company develops AI solutions that automatically detect and prioritize life-threatening conditions...Read more
2024 26 Mar
Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies, the company develops AI solutions that automatically detect and prioritize life-threatening conditions...Read more
2024 26 Mar
Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies, the company develops AI solutions that automatically detect and prioritize life-threatening conditions...Read more
2024 09 Jan
FDA cleared, evidence-based AI and machine learning-based algorithm detects heart disease-associated ischemia Cleerly, the company working to create a new standard of care for the diagnosis of heart disease, today announced the launch of Cleerly ISCHEMIA, which recently received U.S. Food and Drug Administration (FDA) 510(k) medical device...Read more
2021 12 Apr
Masimo (NASDAQ: MASI) announced today that Radius PCG™, a portable real-time capnograph with wireless Bluetooth® connectivity, has received FDA 510(k) clearance. Radius PCG connects with the Root® Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography for patients of all ages. Radius PCG joins the growing...Read more
2017 25 Sep
Masimo Rad-97™ Pulse CO-Oximeter® (center), Rad-97 with Integrated Noninvasive Blood Pressure (left), and Rad-97 with Integrated NomoLine™ Capnography (right) Masimo has announced FDA 510(k) clearance and full market release of Rad-97™ Pulse CO-Oximeter®,including configurations with integrated NomoLine™ capnography and noninvasive blood...Read more