The U.S. market for patient monitoring devices and equipment includes products that are designed to measure and observe changes in vital signs or the neurological, homodynamic, and cardiac functions of a patient. Due to the effects of COVID19, health care workers have recently begun the shift to remote patient monitoring (RPM) options, such as telehealth
BioSerenity, Inc., recently announced they received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Neuronaute® Electroencephalography (EEG) System and IceCap® EEG wearable device that allows physicians to remotely monitor patients with epilepsy. In general, EEG devices record the electrical activity of neurons in the brain through electrodes placed on the scalp (non-invasive) or
Amidst the global COVID-19 pandemic, The FDA has granted enforcement discretion allowing CapsoVision the ability to launch at-home administration of CapsoCam Plus®. This device consists of a video capsule system intended for further visualization of the small bowel mucosa in adults. Gastrointestinal (GI) endoscopes are flexible visualization instruments that are inserted into the alimentary canal
Gastrointestinal testing and surveying methods, such as endoscopies and colonoscopies, are often very invasive and are limited in how much of the small intestine they can reach. Thus, there is a need to develop devices or techniques that can both increase the visibility of the gastrointestinal tract and decrease invasiveness while preserving functionality. Pill-shaped forms
B. Braun has received FDA 510(k) clearance for its MRI system SpaceStation MRI. Based out of Germany, B. Braun is a leader of infusion therapy and medical imaging devices, as well as a variety of other medical devices. This new imaging technology differs from other MRI systems as it can be used with the Space
Currently, the demand for healthcare workers and facilities is extraordinarily high in areas heavily affected by COVID-19. The demand for patient monitoring devices is also high. One of the biggest challenges in reducing the spread of the virus is contact tracing, which is made difficult through a high demand for health personnel, and because of
Researchers at UCSF have developed a method to help detect diabetes using a smartphone. They have developed a deep-learning technology that can be combined with a mobile app to offer a low-cost method of detecting diabetes. Instant Heart Rate Measurement The Azumio Instant Heart Rate app was recently used as part of the Health eHeart
Philips has announced the launch of two portable biomedical products, after obtaining FDA approval for them: the Tempus ALS and Tempus Pro. Both of the devices are designed for use with Philips’ Intellispace Corsium software. This web-based platform is used to record and upload data real-time, and it can be used for communication. This adds
Vitls Inc., a company based out of Houston, Texas, has received 510(k) clearance from the FDA for its Vitls Platform, a telemonitoring system. This platform provides a streamlined process of vital sign monitoring by allowing healthcare providers to view several health metrics from a single device. This clinical-grade platform provides reliable and accurate monitoring in
Medtronic has received a CE mark for its Micra AV Pacemaker, the world’s smallest pacemaker with atrioventricular (AV) synchrony. This device is used to treat AV block, a condition marked by impaired neural signals between atrial and ventricular chambers in the heart. AV block can lead to irregular beat, and in some cases, increased risk
