Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cognetivity Neurosciences, Geneoscopy, Inotec AMD, Perspectum.
A five-minute artificial intelligence (AI)-based system from Cognetivity Neurosciences Ltd. that can detect common symptoms of Alzheimer’s disease years before they become visible using a tablet or smartphone is poised to change how this devastating disease is diagnosed.
GE Healthcare and Sophia Genetics SA partnered to develop new artificial intelligence (AI)-powered analytics and workflow solutions to improve patient matching with cancer therapies.
PARIS – One year on from launch, Digitale Gesundheitsanwendungen (DiGA), or digital health applications, are gaining widespread acceptance in Germany. Digital therapeutics (DTx) have been available since 2020 to the 73 million people in Germany covered by public health.
PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets.
It’s a good time to be a virtual research organization, with investors apparently eager to get into the segment. As part of that trend, Obviohealth Inc. reported it raised $31 million in series B financing, following on the heels of 4G Clinical's announcement on Tuesday of a $230 million investment by Goldman Sachs Asset Management and a $280 million transaction for Science 37 in May 2021.
The World Health Organization’s (WHO) guidance for ethics and governance for artificial intelligence (AI) in health discusses several issues regarding regulation, including the question of transparency for the algorithm’s source code. The WHO paper is not prescriptive on this and several other issues, however, raising the prospect that regulatory entities will not be discouraged from adopting policies that run afoul of intellectual property concerns and thus impede advances in AI.
An artificial intelligence (AI)-powered tool invented by researchers from a trio of Singaporean institutions could speed up the diagnosis of cardiovascular diseases. The innovation uses electrocardiograms (ECGs) to diagnose coronary artery disease, myocardial infarction and congestive heart failure.
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