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.
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.
TORONTO – Hemocath Ltd. is gearing up for a first-in-human trial of a device that addresses two critical metrics for the treatment of heart failure: pulmonary artery and central venous pressure. Hemocath’s pulmonary artery catheter (PAC) is part of a larger heart failure monitoring platform and is intended to assess fluid status in patients with severe or worsening congestive heart failure. The hope is to replace larger, more invasive catheters inserted into a patient’s neck.
PERTH, Australia – With a fresh injection of A$28.9 million (US$22.4 million) in grant funding from the Australian government and a capital raise of A$40 million, 4dmedical Ltd. is well on its way to commercializing its first lung imaging product in the U.S. and Australia. 4dmedical’s X-ray velocimetry (XV) technology is the first FDA-cleared respiratory imaging solution that uses mathematical models and algorithms to convert sequences of X-ray images into four-dimensional quantitative data.