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Cambridge, MA-based artificial intelligence (AI)-driven health technology company, Anumana, has announced its receipt of the International Organization for Standardization (ISO) 13485 certification for its Quality Management System. ECG-AI LEF, the company’s breakthrough AI algorithm, received U.S.
milla1cf Wed, 01/03/2024 - 12:09 January 3, 2024 — iRhythm Technologies, Inc. , Furthermore, the certification incorporates CE mark for the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor. “The Data on file.
Stereotaxis has now received its updated EU Quality Management System Certificate. This certificate shows that the Stereotaxis Quality System is in accordance with MDR and that Stereotaxis’ products now have a valid CE Mark under MDR. This MDR certification will support regulatory clearances of upcoming innovations.
Innovations in cardiac imaging have fundamentally advanced the understanding and treatment of cardiovascular disease. However, we hypothesize that there is significant variation in the availability of cardiac imaging expertise and a disparity in the adoption of advanced imaging technologies across the United States.
As a result, innovative service providers are growing rapidly by leveraging integrated remote monitoring solutions to provide ECGs via extensive pharmacy networks. This requires obtaining local certification for the telemedicine system used, which must share data with public electronic health records that are being set-up for each region.
The national registry reports play a vital role in collecting the data so that new methods can be innovated for the treatment of growing diseases. The software that you use must: Collect data using the operational standards and industry-leading technology. Various cath labs software can be utilized for this purpose.
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