Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine, Fluxergy, Rapid Medical, Tiger Tech.
The rapidly expanding field artificial intelligence (AI)-aided image analysis received a boost with the FDA 510(k) clearance for Optellum Ltd.’s Virtual Nodule Clinic, which helps clinicians evaluate small, potentially malignant lung lesions or nodules. The action makes Optellum’s system the first cleared radiomic application for early lung cancer, an area of active research for the last five years.
The U.S. FDA has granted breakthrough device designation to Tempus Inc. for its ECG Analysis Platform. Developed in collaboration with Geisinger, the artificial intelligence (AI)-powered platform helps clinicians identify patients at increased risk of developing atrial fibrillation (AF) or atrial flutter.
HONG KONG – Israel and U.S.-based Rsip Vision Ltd. unveiled an advanced joint segmentation tool to assist with the planning of revision arthroplasty and other orthopedic procedures for patients with pre-existing metal implants. The detailed, noninvasive artificial intelligence (AI)-based software module enables quick and accurate segmentation of different joints from CT scans of hips, knees, shoulder and spines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biotia, Diazyme, Helio Health, Letsgetchecked, Mesi, Natera, Tempus, Tivic Health, Twist Bioscience.
Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S.
CAJICA, Colombia – The COVID-19 pandemic has exposed the weaknesses of Mexico’s techno-vigilance system, along with a chronic lack of reporting of inventories and adverse effects related to medical devices in use. These weaknesses were exposed during previous pandemics but the country’s antiquated tracking and reporting system has not changed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainscope, Optellum, Ortho Clinical Diagnostics, Shape Memory Medical.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIJ seeks feedback on apps for mental health.
PARIS – Whitelab Genomics SAS has signed a partnership agreement with Genethon, a French research center in the field of gene therapy, to ramp up development of genetic therapy techniques using artificial intelligence (AI). As part of this partnership, Genethon will use the Whitelab Genomics Catalyst platform to develop new capsids.
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