Search Tag: FDA
Novalung System Receives US FDA Clearance
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
Evolving Role of Artificial Intelligence in Radiological Imaging
2020 25 Feb
Find The FDA on Social Media Read more
The Internet of Things and On-line Security
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
A primer on next generation sequencing data analytics
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
Top Target Treatments infographic
2019 22 May
Top target treatments and application of personalised medicine in healthcare Read more
Tiered FDA medical device security guidance concerns industry
2019 26 Mar
The U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions. In the draft, a two-tiered system for identifying cyber risk is proposed, with higher risk devices falling into Tier 1 while other devices would be of “Standard Cybersecurity Risk” or Tier 2.... Read more
#ECR2019: Paediatric CEUS: a fantastic tool
2019 06 Mar
Dr. Paul Sidhu , professor of Imaging Sciences and Consultant Radiologist King’s College London , UK, and President Elect of the European Federation of Societies for Ultrasound in Medicine and Biology ( EFSUMB ) presented the Luigi Oliva Honorary Lecture at ECR2019 . Professor Sidhu opened his lecture saying “I fully appreciate that ultrasound... Read more
FDA Guidance for Mobile Devices
2017 02 Jan
Amid criticism that it was not doing enough to address the cyber vulnerabilities in medical devices, the U.S. Food and Drug Administration has issued guidelines on how manufacturers can protect their products against cyberattacks. According to the guidelines, manufacturers must build cybersecurity controls into medical devices during the development... Read more
MRI-Guided Ultrasound to Treat Tremor Gets OK From FDA
2016 12 Jul
The U.S. Food and Drug Administration ( FDA ) has given the green light to a focused ultrasound device that uses magnetic resonance (MR) images taken during the procedure to treat essential tremor in patients who have not responded to medication. ExAblate Neuro, manufactured by InSightec in Dallas, Texas, delivers focused ultrasound to destroy... Read more