Search Tag: FDA

Sedana Medical Receives IND Approval for US Trials

2021 23 Dec

Sedana Medical AB (publ) has announces that the company has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase III pivotal clinical trials with its Sedaconda products in the United States. Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and... Read more

Sedana Medical Submits IND for US Clinical Trials

2021 24 Nov

Sedana Medical AB (publ) has announces that the company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its phase III pivotal clinical trials with its Sedaconda products in the United States. Sedana Medical is aiming for a combination registration of the medical... Read more

US FDA Approves World’s First Photon-Counting CT System

2021 06 Oct

On September 30, the US FDA approved the Siemens Naeotom Alpha, the world’s first photon-counting computed tomography (CT) scanner through the 510(k) premarket clearance pathway. 510(k) clearance establishes that a medical device is equivalent to a legally marketed predicate device. FDA and CT experts consider this a revolutionary shift in CT scanner... Read more

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