Digital therapeutics company Big Health has been granted FDA 510(k) clearance for its SleepioRx digital therapeutic aimed at reducing insomnia and improving sleep.
The 90-day SleepioRX digital treatment addresses insomnia disorder through evidence-based strategies focusing on the cognitive and behavioral aspects causing insomnia and long-term sleep issues.
The company touts that its use of...
GE HealthCare announced its smartphone-sized Portrait Mobile wireless monitoring solution has received FDA 510(k) clearance, clearing the path to the device becoming commercially available in the U.S.
Designed for in-hospital use, Portrait Mobile aims to shift the paradigm from periodic spot checks to continuous vital sign monitoring for indications of patient decline while freeing the patient...
GE HealthCare announced it received FDA 510(k) clearance for its Precision DL deep learning image processing software.
Precision DL utilizes deep learning, a subset of AI and machine learning, to improve image quality on the company's PET/CT, Omni Legend, and allows for faster scanning time and improved small lesion detection. The software is the company's latest addition to its Effortless Recon...
South Korean medtech firm Coreline Soft has obtained the United States Food and Drug Administration's 510(k) clearance for its latest AI-powered analysis software for screening lung nodules.
The company develops AI imaging solutions for diagnosing various chest conditions, aortic disease, spinal disease, and metastatic cancer in the chest.
WHAT IT DOES
Its latest software-as-a-medical device...
Israeli company ChroniSense Medical received FDA 510(k) clearance for its Polso wearable that collects and shares vital signs via a mobile app for patients and a cloud-based platform for clinicians.
The wrist-worn wearable enables clinicians to monitor patients' vitals, including blood oxygen saturation (SpO2), pulse rate and respiration rate. The company touts the watch as ideal for remote...
Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG) system, Seer Home, which helps providers diagnose epilepsy.
Seer Home’s EEG system enables patients to undergo week-long studies at home. Patients wear a device – the Seer Sense – around their shoulders with electrodes connected to the patient’s skull and chest to record brain (EEG) and...
