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A clinician can input case information, download and mark up an ECG in Vektor Medical’s vMap in less than three minutes, using only ECG data and receive a three-dimensional, interactive arrhythmia hot-spot map visualizing the inside and outside of the heart. Read More
The FDA classifies Apple’s Irregular Rhythm Notification Feature 2.0 app as “photoplethysmograph analysis software for over-the-counter use,” a Class II (Special Controls) device. Read More
Talis Biomedical’s Talis One diagnostic system is a qualitative in vitro real-time nucleic acid amplification test to be used in individuals suspected of having COVID-19 by their healthcare provider. Read More
The Logix Smart test kit is an in vitro diagnostic test that does qualitative detection of the RNA from the SARS-CoV-2 coronavirus that causes COVID-19. Read More
When inflated, the balloon part of the Flume catheter envelops the tip so that the emptying bladder makes contact with the flexible balloon surface rather than the rigid catheter tip. Read More
ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in people with reduced ankle function related to neurological injuries, such as stroke. Read More
Insightec’s Exablate Neuro uses focused ultrasound waves; it is incisionless, does not require brain implants and has less risk of infection than invasive surgery. Read More
Liquidia has grabbed tentative FDA approval for Yutrepia, the first inhalation powder form of treprostinil, a vasodilator used in other forms to treat pulmonary hypertension. Read More
The additional clearance for MIM Software’s Contour ProtégéAI covers head and neck, thorax, prostate and abdomen contours for the software, which is used with radiation therapy. Read More
Neoteny’s Acliv is intended for application as an LCD protective film for medical devices and smartphones, as well as for kiosk and screen protectors. Read More