March 19, 2020 Until now, the test — a real-time RT-PCR panel that searches for traces of viral RNA in nasal or oral swab — could only be used to evaluate samples shipped to the CDC’s own labs, slowing the (FDA) Agency’s turnaround time in responding to the spread of the disease. FDA Commissioner Stephen … Read more
March 17, 2020 Developed by the London-based Contura, the Bulkamid hydrogel also acts as a scaffold for growing cells, to provide longer-lasting treatment. The injection was first granted a CE mark in 2003, and the company says that over 70,000 women have been treated to date in more than 25 countries.”We are extremely proud to … Read more
March 10, 2020 Blood testing is ubiquitous; however, it is clear its possibilities are unfulfilled. Through different methods and modalities, these diagnostics promise to be a more accessible, less invasive, smarter, cheaper and a comprehensive way to gather knowledge about what’s going on under the skin — whether in a doctor’s office, at home or … Read more
March 05, 2020 A court in Shenzhen found that He, an Associate Professor at the nearby Southern University of Science and Technology, and two (2) embryologist colleagues were guilty of an “illegal medical practice” that resulted in the birth of twin girls with altered genomes. In November 2018, the Researcher publicized his plans to edit … Read more
March 03, 2020 By using programs trained on 2D and 3D mammography images from nearly 30,000 women in the U.S. and the U.K., DeepMind’s system was able to identify those that had their cancer confirmed within the following year via a tissue biopsy or subsequent X-rays. Among patients from the U.S., the AI (artificial intelligence) … Read more
February 28, 2020 The TOMi Scope diagnostic device uses optical coherence tomography, or OCT, to scan the middle ear with near-infrared light and provide a cross-section image similar to an ultrasound. It can then determine whether fluid is present and characterize its type and density, even in cases with heavy wax buildup. “Current tools can … Read more
February 25, 2020 In pivotal study results published in The Lancet Neurology, Evoke spinal cord device reduced or eliminated the use of opioid painkillers after one year among 55% of treated patients, compared to 40% of those who received open-loop stimulation. Evoke gauges the body’s reaction to every electrical pulse and works to optimize its … Read more
February 20, 2020 The ScanWatch also works as an activity and fitness tracker, with the ability to measure V02 max, which gauges the amount of oxygen utilized during aerobic exercise, in addition to its electrocardiogram (ECG). “ScanWatch is our most ambitious medical tracker and purposely designed to detect the early presence of AFib and sleep … Read more
February 18, 2020 In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, the US discusses the MDR/IVDR issues facing industry. “Our industry is worried about their continued access to the EU’s USD 125 billion medical device market, USD 20 billion of which is supplied by US products.” … Read more
February 15, 2020 The Agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order. FDA’s rule is meant to improve the device premarket submission program and create a more efficient … Read more