Search Tag: FDA
FDA Clearance for Masimo O3® Regional Oximetry for Extended Use in Cerebral & Somatic Applications
2020 31 Aug
Masimo today announced that O3® Regional Oximetry has received FDA clearance for expanded use in monitoring somatic tissue oxygenation saturation in all patient populations and monitoring relative changes in hemoglobin, oxyhemoglobin, and deoxyhemoglobin in adult brains. With this FDA clearance, O3 is now indicated for use in both cerebral and somatic... Read more
Getinge’s New Anesthesia Machines, Flow-e And Flow-c, Receive 510(K) Clearance
2020 26 Aug
US Food & Drug Administration (FDA) clears Getinge’s Flow-e and Flow-c Anesthesia Systems. Getinge extends the family of Flow anesthesia machines with Flow-e and Flow-c, which share the same Flow Family core technology and offers personalized anesthesia delivery for even the most challenging patients, from neonates and pediatric to the morbidly obese.... Read more
Masimo Expands the Masimo SafetyNet™️ Solution with Continuous Body Temperature Measurement
2020 27 Jul
The Radius Tº™ Wearable Temperature Sensor Automates Remote Monitoring of Patient Temperature Status Masimo today announced a significant expansion to the Masimo SafetyNet™ platform with the introduction of Radius Tº™, a wearable, wireless sensor that provides continuous body temperature measurements. By augmenting the already powerful Masimo... Read more
Getinge Receives 510(k) Clearance From US FDA For The Servo-air® Mechanical Ventilator
2020 07 Jul
Getinge has received 510(k) clearance from the US Food & Drug Administration (FDA) for the company’s Servo-air® mechanical ventilator, which is part of the Servo family that supports intensive care ventilation ever since the first model was introduced in 1971. "We are happy to be able to help clinicians in their endeavor to save lives by adding... Read more
How Can An Infusion Pump Do with Safer Medication?
2020 12 May
Medication error is one of the major causes of people's death, estimated to cost around 42 billion US dollars globally every year[1]. Among them, administering with wrong drug is one of the most common types that results in death[2]. Safe medication is always the goal that medical professionals are pursuing. There are different reasons... Read more
COVID-19 Total Antibody Test from Ortho Clinical Diagnostics Receives CE Mark
2020 12 May
-Ortho’s COVID-19 total antibody test receives CE Mark -Ortho’s total antibody test may be used as aid in diagnosis and to support decisions for getting people back to work -The test offers excellent performance, with 100 percent specificity and sensitivity -Ortho began shipping its antibody test to customers in highly impacted geographies and plans... Read more
FDA Grants ExThera’s Seraph-100 Blood Filter Emergency Use Authorization for COVID-19
2020 17 Apr
After promising COVID-19 treatments in Germany, France, Italy, Spain and the USA, ExThera Medical ’s Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) has been granted Emergency Use Authorization by the Food and Drug Administration (FDA). This approval comes soon after first use of the device to treat COVID-19 patients in Europe and in... Read more
Novalung System Receives US FDA Clearance
2020 26 Feb
The US FDA (Food and Drug Administration) has granted 510(k) approval to Fresenius Medical Care North America and Xenios, a Fresenius Medical Care company, for long-term use of its Novalung system for patients with acute lung failure or acute cardiopulmonary failure. The FDA announced this on Friday evening. With class II approval, the Novalung... Read more
Evolving Role of Artificial Intelligence in Radiological Imaging
2020 25 Feb
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The Internet of Things and On-line Security
2019 03 Sep
The Internet of Things (IoT) means all sorts of devices we use today, be it at home or in the workplace, are practically linked/connected to each other or to a network. While such connectivity leads to improved efficiency in what we do (eg, smartphones for fast communication), security experts warn that the IoT puts these connected devices at... Read more