Search Tag: FDA clearance

2024 29 Apr

International medical imaging IT and Cybersecurity company  Sectra’s  digital pathology solution together with Leica Biosystems, Imaging, Inc.’s Aperio GT 450 DX have received a 510(k) clearance by the US Food & Drug Administration (FDA). This is the first time an FDA clearance within digital pathology allows the use of DICOM images for pathology diagnostics,...Read more

2024 29 Apr

International medical imaging IT and Cybersecurity company  Sectra’s  digital pathology solution together with Leica Biosystems, Imaging, Inc.’s Aperio GT 450 DX have received a 510(k) clearance by the US Food & Drug Administration (FDA). This is the first time an FDA clearance within digital pathology allows the use of DICOM images for pathology diagnostics,...Read more

2024 29 Apr

International medical imaging IT and Cybersecurity company  Sectra’s  digital pathology solution together with Leica Biosystems, Imaging, Inc.’s Aperio GT 450 DX have received a 510(k) clearance by the US Food & Drug Administration (FDA). This is the first time an FDA clearance within digital pathology allows the use of DICOM images for pathology diagnostics,...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 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