Search Tag: FDA
FDA Amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay
2020 06 Oct
Hologic, Inc. announced today that its Aptima® SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May, is now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection. This authorization follows an announcement last week... Read more
Michael Porter Of Harvard Business School Has Joined The Board Of Directors Of Exthera Medical
2020 29 Sep
Michael Porter, Ph.D., has joined the board of directors of ExThera Medical Corporation, a privately held medical technology company focused on the therapeutic reduction of drug-resistant pathogens and sepsis mediators in whole blood. ExThera’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) has a CE Mark in Europe for the treatment... Read more
Siemens Healthineers Announces Collaboration Agreement with Novartis
2020 21 Sep
Siemens Healthineers and Novartis collaboration to develop assays supporting Novartis’s therapeutic pipeline. Initial program to focus on development of serum neurofilament light chain (sNFL) immunoassay for people living with Multiple Sclerosis (MS) and other neurological diseases. Global distribution on Siemens Healthineers immunoassay platforms.... Read more
Siemens Healthineers Announces Collaboration Agreement with Novartis
2020 21 Sep
Siemens Healthineers and Novartis collaboration to develop assays supporting Novartis’s therapeutic pipeline. Initial program to focus on development of serum neurofilament light chain (sNFL) immunoassay for people living with Multiple Sclerosis (MS) and other neurological diseases. Global distribution on Siemens Healthineers immunoassay platforms.... Read more
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