Search Tag: FDA
2023 03 Oct
Nova Biomedical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a micro capillary sample mode on the Stat Profile Prime Plus® Critical Care analyzer. Prime Plus now performs an 11-test panel including pH, PCO2, PO2, Na, K, iCa, iMg, Cl, glucose, lactate, and hematocrit with just 90 microliters...Read more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
2016 28 Jun
Radius-7 is the First Wearable, Tetherless, Noninvasive rainbow® Monitor Masimo has announced FDA 510(k) clearance for Radius-7® – the first and only wearable, tetherless, noninvasive rainbow® monitor. Radius-7, which connects to the Root® patient monitoring and connectivity platform, is now available in the U.S. with breakthrough Masimo rainbow® technoRead more
2015 29 Jun
Potential game changer for treatment and containment A new test can accurately diagnose Ebola virus disease within minutes, providing clinicians with crucial information for treating patients and containing outbreaks. Researchers from Harvard Medical School, Partners In Health and Boston Children's Hospital have shown that a new commercially developed...Read more
2015 29 Jun
Teleflex Incorporated announced today that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall of Hudson RCI® LIFESAVER® Neonate Manual Resuscitator as a Class 1 recall. FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product...Read more
2014 04 Jul
Masimo has announced FDA 510(k) clearance of the Root™ patient monitoring and connectivity platform that is destined to transform patient care throughout the hospital. High-impact innovations in Root that are now available in the U.S. include: Iris™ - Built-in connectivity gateway through Iris™ for standalone devices such as IV pumps, ventilators,...Read more