Diagnostics

B. Braun Gains FDA Clearance for SpaceStation MRI

B. Braun Gains FDA Clearance for SpaceStation MRI

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

iData ResearchB. Braun Gains FDA Clearance for SpaceStation MRI
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Fitbit Used for Early Detection of COVID-19 Symptoms

Fitbit Used for Early Detection of COVID-19 Symptoms

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

iData ResearchFitbit Used for Early Detection of COVID-19 Symptoms
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Philips Launches Two Portable Biomedical Products In US

Philips Launches Two Portable Biomedical Products In US

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

iData ResearchPhilips Launches Two Portable Biomedical Products In US
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New Cornea Imaging Technique Provides Higher Level of Detail

New Cornea Imaging Technique Provides Higher Level of Detail

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 the cornea and provides a larger field of view. This also allows for the viewing

iData ResearchNew Cornea Imaging Technique Provides Higher Level of Detail
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Vitls Inc. Granted FDA Clearance of Clinical-Grade Vital Sign Telemonitoring System for Hospital and Home Use

Vitls Inc. Granted FDA Clearance of Clinical-Grade Vital Sign Telemonitoring System for Hospital and Home Use

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

iData ResearchVitls Inc. Granted FDA Clearance of Clinical-Grade Vital Sign Telemonitoring System for Hospital and Home Use
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Medtronic receives CE mark for Micra AV Pacemaker

Medtronic receives CE mark for Micra AV Pacemaker

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

iData ResearchMedtronic receives CE mark for Micra AV Pacemaker
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Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System

Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System

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 potential arrhythmias, then verifies them. When an arrhythmia is verified, clinicians are immediately alerted, so

iData ResearchBoston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System
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Beckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test

Beckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test

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 is likely more effective than other tests, as most others test for the immunoglobulin (IgM)

iData ResearchBeckman Coulter Granted FDA EUA for COVID-19 IgG Antibody Test
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Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor

Abbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor

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 several innovative features. It is the only iCGM system that measures glucose levels each minute,

iData ResearchAbbott Granted FDA Approval for Freestyle Libre 2 Glucose Monitor
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Medtronic Recalls MiniMed Insulin Pumps for Incorrect Dosages

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Medtronic Recalls MiniMed Insulin Pumps for Incorrect Dosages

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. In the defective devices, the retainer ring, which is supposed to lock the insulin cartridge

iData ResearchMedtronic Recalls MiniMed Insulin Pumps for Incorrect Dosages
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