February 17, 2022 The MedTech industry welcomed the broad goals of the proposed rule published late in 2018; however, pushed back hard against some of its provisions, notably with regard to FDA’s plans to carry out premarket manufacturing inspections. FDA, while making some tweaks to the draft, held firm on the main points of friction … Read more
February 16, 2022 “You can’t have a safe and effective medical device if it’s unavailable” due to ransomware, Fu told AdvaMed’s Annual Conference in October 2021, noting a big change in the MedTech industry over the past decade in terms of acknowledging growing cyber threats to devices. “Nation states and organized crime — real threat … Read more
February 10, 2022 Dive Insight: FDA published the draft guidance on patient engagement in 2019 and followed up with the release of the text 12 months later. Having reviewed feedback submitted about the drafts, FDA has published the final versions of the documents. The Agency has retained the structure and core content of the drafts … Read more
February 08, 2022 California Governor Gavin Newsom has extended an Executive Order (EO) enabling physicians to conduct routine and non-emergency telehealth services without risk of being penalized for the inadvertent release of patient data. Executive Order N-16-21 continues an order put in place in April of 2020, during the height of the pandemic, which gave … Read more
February 03, 2022 Three (3) Biomedical Engineering Graduates from the University of South Florida (USF) in the United States have developed a lifesaving medical ventilator to support the Covid-19 crisis. Carolyna Yamamoto Alves Pinto, Abby Blocker and Jacob Yarinsky have developed the patent-pending prototype device, Eucovent, that allows two patients to be ventilated by a … Read more
February 01, 2022 Each year around two million women around the world are diagnosed with breast cancer. Typically, tissue samples of the tumor are taken and analyzed and then the cancer is placed into one (1) of three (3) categories – low risk, or grade 1; medium risk, or grade 2; and high risk, or … Read more
January 28, 2022 Applied directly to the skin, the microneedle patch reportedly delivered an immune response ten (10) times greater than a vaccine delivered into an arm muscle via a needle jab. The microneedle patch also has other advantages, including easy and painless delivery, and the potential to be self-administered. “In developing this technology, we … Read more
January 25, 2022 FDA previously announced it would halt certain inspectional activities out of concern for its employees and those of the companies it regulates amid the wave of COVID-19 infections driven by the Omicron COVID-19 variant. At the time, the Agency said it would continue to conduct “mission-critical” work through 19 January 2022. In … Read more
January 20, 2022 A pioneering EEG test could dramatically increase early diagnosis of Alzheimer’s, researchers have announced. Scientists have developed a two-minute passive-test called Fastball EEG that measures people’s brain waves in response to a series of images, potentially helping diagnose dementia earlier. Participants look at a series of flashing images on a computer screen … Read more
January 18, 2022 Many of the body’s physiological activities, including hunger, wakefulness, and metabolism, run on 24 hour cycles called circadian rhythms. These cycles are primarily controlled by the release of chemical messengers into the bloodstream from the brain and have been linked to cardiovascular disease, neurodegenerative disorders, and weight-gain. Measuring circadian rhythms could significantly … Read more