Search Tag: FDA

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The U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions.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

Cardiology Management

FDA Approves First Absorbable Cardiac Stent

2016 05 Jul

The US Food and Drug Administration (FDA) has approved the  Absorb  GT1 Bioresorbable Vascular System (Abbott Vascular), with the first absorbable stent for coronary artery disease. Nine members of the Circulatory System Devices panel vs 1 voted that it was safe, and 9 to 1 voted that it had an acceptable risk/benefit profile. In addition, all 10... Read more

ICU Management

Masimo Announces FDA 510(k) Clearance for Radius-7® with rainbow® Technology

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... Read more

Executive Health Management

FDA Approves Use of the Procleix Zika Virus Assay from Hologic & Grifols

2016 21 Jun

--Blood banks will use the new test, co-developed by Hologic and Grifols, to screen donated blood in potential endemic areas of the US-- --Test will run on the Procleix Panther System, a fully automated NAT blood screening platform-- Hologic , Inc. and  Grifols  – market-leading partners committed to blood safety - has announced that the U.S.... Read more