Israeli-based digital health technology company GrayMatters Health, which develops self-neuromodulation therapies for mental disorders, received FDA 510(k) clearance for its PTSD-focused neuromodulation therapy dubbed Prism.
The company uses a proprietary model to create a unique patient amygdala-derived biomarker, using synchronized data from several sessions of electroencephalograms (EEGs)...
Volpara Health, a maker of an artificial intelligence-enabled breast health platform, has added another FDA clearance to its core algorithm, the Volpara Imaging Software (VIS 3.2).
This marks the fourth clearance for Volpara’s breast health platform since its original authorization back in 2010, according to the company. The platform includes a suite of products that help with the early detection...
Wireless healthcare technology developer LifeSignals today shared that it has received FDA 510(k) clearance for its LX1550 Multiparameter Remote Monitoring Platform.
LifeSignals’ remote patient monitoring system consists of a single-use wearable biosensor that measures electrocardiography, heart rate, respiration rate, skin temperature and body posture data for up to five days. The biosensor...
Remote pregnancy monitoring company Nuvo Group announced today the FDA has granted supplemental 510(k) clearance to add a new uterine activity module to its INVU system.
INVU is a physician-prescribed, wearable pregnancy monitoring system that allows women to remotely collect fetal and maternal heart rates – and now uterine activity – while sharing data in real-time with their doctor.
The FDA...
A new startup called Whiterabbit has emerged from stealth to announce its new CEO and the FDA clearance of its artificial intelligence-enabled breast cancer screening product.
The company has developed a line of products targeting the mammography space to enable early and accurate breast cancer detection, with the goal of eradicating late-stage breast cancers in the U.S. by 2025.
The WRDensity...
This morning, Bigfoot Biomedical announced it has received FDA 510(k) clearance for its Bigfoot Unity Diabetes Management System.
The system was cleared for use among individuals 12 years old and up with Type 1 or Type 2 diabetes who use multiple-dose injection therapy.
Included in the Bigfoot Unity System are two smartpen caps for both rapid- and long-acting insulin, a connected mobile app, an...
Theranica, an Israeli prescription digital therapeutics developer for migraine and other pain conditions, has received 510(k) clearance from the U.S. Food and Drug Administration for its Nerivio device.
The device has been cleared for acute treatment of episodic or chronic migraine in people 12 years and older.
Nerivio is a wireless, noninvasive remote electrical-stimulation wearable that is worn...
Zebra Medical Vision has announced its latest Food and Drug Administration 510(k) clearance for HealthMammo, an artificial intelligence tool that helps radiologists identify suspicious mammograms.
The AI tool works by automatically sending mammograms to the analytic platform to be searched for breast lesions. HealthMammo then marks each mammogram as either “suspicious” or “not suspicious” for the...
Gainesville, Florida-based etectRx has received FDA 510(k) clearance for its ID-Cap System, a prescription ingestible system that sends adherence event logs to an external medical device.
Similar to the system pioneered by etectRx’s high-profile competitor, Proteus Digital Health, the ID-Cap’s core is a standard capsule containing a sensor that transmits a message once it comes into contact with...
Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate.
Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a...
