Posts filed under: Diagnostics

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...
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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...
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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...
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A multi-institutional group of researchers, including some at the Langevin Institute in France, has developed a new optical instrument to view the cornea, using a technique based on optical coherence tomography (OCT). However, this new device matches the curvature of...
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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...
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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...
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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...
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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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The most recent integrated continuous glucose monitor (iCGM) from Abbott, the Freestyle Libre 2, has been granted FDA approval for sale in the U.S. to adults and children over the age of four with diabetes. The Freestyle Libre 2 has...
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Medtronic has recalled the MiniMed 600 Series Insulin Pumps due to missing or broken retainer rings resulting in incorrect insulin dosages. The MiniMed Insulin Pumps are designed to administer proper doses of insulin when the user’s blood sugar levels dip....
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