October 21, 2020
The past couple of days have seen a handful of artificial intelligence algorithms for radiology imaging analysis receive 510(k) clearances from the FDA. Two of these, from Quantib and Ezra, are focused on the relatively untouched area of prostate cancer screening, while a third, from Aidoc, targets incidental pulmonary embolism.
Quantib's software delivers an in-workflow assessment of prostate...
October 6, 2020
The FDA has issued an Emergency Use Authorization (EUA) to a clinical decision support (CDS) tool that predicts when an adult patient admitted to the hospital with COVID-19 is at risk of further complications.
Developed by Oakland, California-based diagnostic algorithm developer Dascena, the COViage Hemodynamic Instability and Respiratory Decompensation Prediction System reviews demographic and...
July 30, 2019
PhysIQ has received 510(k) clearance for an algorithm facilitating cloud-based analysis of patients’ continuous ambulatory respiration rates, according to an update to the FDA’s device clearance database that was confirmed by the company to MobiHealthNews.
This regulatory clearance is the company’s third, and like its predecessors uses artificial intelligence to characterize raw sensor data as...
June 19, 2019
In an effort to tackle in-home cardiac arrest, University of Washington researchers have devised a novel contactless system that uses smartphones or voice-based personal assistants to identify telltale breathing patterns that accompany an attack.
The proof-of-concept strategy, described in an NPJ Digital Medicine paper published this morning, involved a supervised machine learning model called a...
June 17, 2019
The past week has seen two FDA clearances awarded to Israeli companies building artificial intelligence analysis tools for medical imaging.
The first, announced last Tuesday, was Aidoc’s tool for triaging cervical spine fractures. Much like the company’s prior offerings, the new product analyzes images to prioritize high-risk cases for review by a radiologist, and does so within the specialist’s...
May 15, 2019
Aidoc, an Israeli provider of artificial intelligence products for radiologists, announced today that it has received FDA clearance for a tool that identifies potential cases of pulmonary embolism — a blockage in one of the lung’s pulmonary arteries — for expert review.
“We chose to focus on this product because these are patients who might not necessarily have clear symptoms of pulmonary...
May 13, 2019
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced yesterday that it has received an 510(k) clearance for an artificial intelligence tool that can read medical imaging to identify potential cases of pneumothorax — a build-up of gas between a lung and the chest wall.
The HealthPNX product scans a chest X-ray or digital radiography scan for signs of the condition,...
November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October.
Results generated by the algorithm-based software are...
October 2, 2018
New features to personalize practices. Miami-based EHR and practice management software company CareCloud announced that it is expanding its platform with a slew of new features for its platform Breeze. Among these are support for personalized URLs and webpages for practices, configurable patient feedback surveys, and a new patient experience management dashboard. Breeze, which includes native...