Search Tag: FDA
FDA Recommends Against Reuse of Respirators
2021 12 Apr
The U.S. Food and Drug Administration (FDA) has released new recommendations regarding the use of disposable respirators suggesting “transition away from crisis capacity conservation strategies”. You might also like: Two initiatives look into the options to safely reuse the masks and one connects hospitals with personal protective... Read more
Masimo Announces FDA Clearance of Radius PCG™ for Root® Patient Monitoring & Connectivity Platform
2021 12 Apr
Masimo (NASDAQ: MASI) announced today that Radius PCG™, a portable real-time capnograph with wireless Bluetooth® connectivity, has received FDA 510(k) clearance. Radius PCG connects with the Root® Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography for patients of all ages. Radius PCG joins the growing... Read more
FDA Grants Emergency Use Authorization for New COVID-19, Flu A, Flu B Combo Kit
2021 16 Feb
One multiplex real-time PCR diagnostic kit can simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific, the company announced today.... Read more
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