Search Tag: FDA

IMAGING Management


2014 27 Jan

FDA Clears Siemens RT Workflow Features RT Pro edition enhances radiation oncology workflow on company’s SOMATOM Definition AS Open CT simulator Siemens Healthcare has announced that the US Food and Drug Administration (FDA) has cleared the RT Pro edition – a package of features designed to enhance radiation oncology workflow for Siemens’...Read more

IMAGING Management


2014 05 Feb

Camera-in-a-pill manufacturer Given Imaging announced that it received US Food and Drug Administration clearance for a pill able to provide visualisation of the colon, making it available to a global market of 3 million procedures per year. The pill, a swallowed capsule endoscope entitled PillCam Colon, is designed for the detection of colon...Read more

IMAGING Management


2014 09 Apr

FDA Clears Siemens’ Cios Alpha Mobile C-arm with Flat-Panel Detector Combination of detector and 25 kW power output yield high-resolution, high-contrast images Field of view up to 25% larger than conventional C-arms Siemens Healthcare has announced that the Food and Drug Administration (FDA) has cleared the Cios Alpha, a dynamic...Read more

IMAGING Management


2014 19 Apr

Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, has announced their latest Class II clearance from the United States (US) Food and Drug Administration (FDA).  The leading enterprise image-viewing solution, ResolutionMD® is now cleared for diagnosis on mobile devices, for all...Read more

IMAGING Management


2014 22 Apr

Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, has announced that ResolutionMD® is first to receive certification from the China Food and Drug Administration (CFDA) for diagnosis on both web and mobile devices for all imaging modalities.  This certification enables medical...Read more

ICU Management


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

IT Management


2014 29 Jul

An under-regulated mobile health industry could create “a Wild West” market, says law professor, Nathan Cortez, writing in the New England Journal of Medicine. Cortez, who has conducted extensive research into FDA regulation of mobile health technologies argues that while mHealth holds great promise, there is a role for government oversight. Out of...Read more

Lab Management


2014 10 Sep

A new laboratory test to gauge severe acute kidney injury (AKI), developed by Astute Medical (San Diego, CA, USA), has been approved for marketing by the US Food and Drug Administration. The manufacturer said its new "NephroCheck" test is intended to be used in critically ill, hospitalised patients. The urine-based test can detect whether a patient...Read more

IT Management


2014 06 Oct

The US Food and Drug Administration (FDA) has announced a new guidance for medical device manufacturers with regard to managing cybersecurity risks to better protect patient health and information. The federal agency noted that some medical devices and computer systems can be vulnerable to security breaches, potentially impacting the safety and effectiveness...Read more

Pharmacy Management


2014 26 Nov

According to a study published in JAMA, one-quarter of recent new drug approvals occurred without any meeting between the FDA and the pharmaceutical companies. Even if a meeting did take place, the pharmaceutical companies did not comply with one-quarter of the recommendations made by the FDA regarding study design or primary outcome.   Federal...Read more

Pharmacy Management


2015 15 Jan

The FDA recently issued a warning that statins could affect memory, attention span and other cognitive abilities of people who are using the drug to control their cholesterol levels. However, a comprehensive review of 25 clinical trials comprising of 47,000 people finds no link between statin use and changes in cognition. The systematic review was...Read more

Health Management


2015 20 Jan

Taha Kass-Hout has been a leader in the fields of health and informatics for nearly two decades. He is the first Chief Health Informatics Officer of the US Food and Drug Administration (FDA). He is also the founder of Humanitarian Tracker, which uses crowdsourcing to map the spread of disease and disasters such as the current crisis in Syria. A...Read more

IT Management


2015 29 Jan

Dexcom, Inc. (San Diego, CA) has become the first company to obtain U.S. Food and Drug Administration (FDA) pre-market approval for its mobile apps to support continuous glucose monitoring. The new apps are intended to make it easier for care managers and loved ones to closely monitor glucose levels to avoid complications, such as hyperglycaemia, which...Read more

Pharmacy Management


2015 30 Jan

A committee of the European Medicines Agency (EMA) has made recommendations that the sale of four dozen generic drugs should be suspended. These include generic medicines for diabetes, depression and hypertension. The recommendations have been made on the grounds that the approval of these drugs was based on flawed clinical studies that had been conducted...Read more

IMAGING Management


2015 23 Apr

Strong growth in 2014 revenues: up 32% Continued improvement in gross margin: up 400 basis points Q1 2015 revenues increase 53% driven by USA EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, announced its consolidated annual results for the year ended December 31, 2014, as approved by...Read more

ICU Management


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

ICU Management


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

Executive Health Management


2015 28 Jul

According to an article published in JAMA Internal Medicine , approximately 10 percent of serious and unexpected adverse events are not reported by drug manufacturers to the U.S. FDA under the 15-day time frame that is set out in federal regulations.  Drug manufacturers are required by law to report serious adverse events including death, life-threatening,...Read more

IT Management


2015 10 Aug

The U.S. Food and Drug Administration has approved the first 3D-printed drug, SPRITAM ® , for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.   The FDA approval is being hailed as a breakthrough in precision...Read more

Executive Health Management


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

ICU Management


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

Cardiology Management


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

IMAGING Management


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

IT Management


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


2019 13 Jun

Find Global Engage on Social Media Read more

IMAGING Management


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

IT Management


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

Executive Health Management


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


2019 22 May

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

Executive Health Management


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