Search Tag: FDA

ICU Management

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

Executive Health Management

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

Executive Health Management

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

Executive Health Management

Top Target Treatments infographic

2019 22 May

Top target treatments and application of personalised medicine in healthcare Read more

IT Management

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The U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions.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

IMAGING Management

#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

IMAGING Management

5th Digital Pathology & AI Congress: USA

2019 13 Jun

Find Global Engage on Social Media Read more

IT Management

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

IMAGING Management

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