Search Tag: FDA
Passionate About Breast Health
2021 16 Jul
Four radiologists share their passion for good breast health—the key to detecting cancer at its earliest, most treatable stage. Hologic has made remarkable strides in the fight against breast cancer. When we introduced the first 3D mammography™ system on the market in 2011, we transformed radiologists’ ability to detect breast cancer earlier... Read more
Sedana Medical Announces Positive FDA Interaction
2021 07 Jul
Sedana Medical AB (publ) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, including study design and primary endpoints for the studies. This positive outcome means that the company can enter phase III... Read more
Masimo Announces FDA 510(k) Clearance of Radius Tº™ for Prescription and Over-the-Counter (OTC) Use
2021 21 Jun
The Radius Tº Wearable Continuous Body Temperature Thermometer Is Now Available for Use in Hospital and at Home Masimo announced today that Radius Tº™, a wearable, wireless thermometer that measures body temperature continuously and noninvasively, has received FDA 510(k) clearance for both prescription and over-the-counter (OTC) use on patients... Read more
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