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
2023 21 Sep
Elon Musk's controversial biotechnology startup, Neuralink, announced that they have received approval from the independent institutional review board to commence recruitment for its first-in-human clinical trial. The P recise R obotically Im planted Brain-Computer Interfac e (BCI) (PRIME study) will investigate brain implants in individuals suffering...Read more
2023 30 Aug
Artificial intelligence (AI) has made significant advancements in various fields, including medical imaging, such as ultrasound (US). AI methods can be employed to enhance the analysis and interpretation of ultrasound images. The trustworthiness of AI in ultrasound depends on various factors and AI algorithms should undergo ongoing monitoring and...Read more
2023 30 Aug
Artificial intelligence (AI) has made significant advancements in various fields, including medical imaging, such as ultrasound (US). AI methods can be employed to enhance the analysis and interpretation of ultrasound images. The trustworthiness of AI in ultrasound depends on various factors and AI algorithms should undergo ongoing monitoring and...Read more
2023 30 Aug
Artificial intelligence (AI) has made significant advancements in various fields, including medical imaging, such as ultrasound (US). AI methods can be employed to enhance the analysis and interpretation of ultrasound images. The trustworthiness of AI in ultrasound depends on various factors and AI algorithms should undergo ongoing monitoring and...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 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
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
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
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
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 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
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 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
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
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 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
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
2019 03 Sep
The Internet of Things (IoT) means all sorts of devices we use today, be it at home or in the workplace, are practically linked/connected to each other or to a network. While such connectivity leads to improved efficiency in what we do (eg, smartphones for fast communication), security experts warn that the IoT puts these connected devices at...Read more
2019 22 May
Next Generation Sequencing (NGS) is rapidly becoming more and more standardised in terms of sequencing techniques. With Precision Medicine coming into the clinical forefront, it is important to know the steps and possibilities associated with Next-Generation Sequencing techniques. Introduction Next Generation Sequencing (NGS) is...Read more