Search Tag: FDA

ICU Management

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

ICU Management

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

ICU Management

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

ICU Management

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

ICU Management

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

Executive Health Management

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

ICU Management

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

ICU Management

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

Executive Health Management

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