Posts filed under: Patient Monitoring
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...
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...
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...
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...
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...
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...
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...
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...
Boston Scientific has been granted FDA 510(k) clearance for their LUX-Dx insertable cardiac monitor system. This long-term diagnostic device is used to detect arrhythmias from conditions such as atrial fibrillation, syncope, and cryptogenic stroke. The LUX-Dx’s multi-stage algorithm first detects...
Beckman Coulter has been granted Emergency Use Authorization by the FDA for its new COVID-19 antibody test. This approval comes after being tested by the top four in vitro diagnostic manufacturers in the U.S. to validate its efficacy. This test...
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