June 11, 2020 A month after FDA tightened oversight of the tests and started withdrawing tests from the market, there is still enough concern about false results that the American Medical Association (AMA) is recommending against people using the tests outside of certain settings, added Dr. Jesse Ehrenfeld, immediate past chair of the AMA’s board … Read more
June 09, 2020 The company’s ongoing Circulating Cell-free Genome Atlas study spans more than 15,000 participants, including those with and without cancer diagnoses. Results presented last year showed the blood test could detect 12 different early-stage cancers — which together account for nearly two-thirds of all cancer deaths in the U.S. — before they had … Read more
June 04, 2020 People with MS often have an increased risk of falling and injuring themselves even when they feel able to walk normally. The study, published in PLoS One, used a VR system to trick subjects into thinking they were falling as they walked on a treadmill, with MS patients reacting very differently to … Read more
June 02, 2020 The federally funded research and development center will use its $6 million National Institutes of Health (NIH) award to create a more comfortable and, perhaps, more accurate magnetoencephalography (MEG) imaging prototype. “This is the future of MEG,” Amir Borna, a Lead Investigator on the project, said in the announcement. Typically, clinicians use magnetoencephalography … Read more
May 28, 2020 Each kit contained material to test a mere 300 to 400 patients. And labs, whether serving the population of New York City (NYC) or tiny towns in rural America, apparently received the same kits. The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, … Read more
May 27, 2020 Both Illumina and IDbyDNA will co-market the latter’s Explify platform — a DNA search engine that can detect and profile over 50,000 microorganisms and 3,000 pathogens in the clinic, as well as antimicrobial resistance — for use on the sequencing giant’s hardware and library preparation systems. Additionally, the two will collaborate on … Read more
May 22, 2020 The company’s Intelligent Surgical Unit is designed as an add-on to its laparoscopic Senhance system, to help augment control of the surgeon’s camera during a minimally invasive procedure. It was first submitted to the FDA for review in mid-January 2020. “We are pleased to have received this important clearance earlier than expected,” … Read more
May 19, 2020 Denver-based BioIntelliSense raised the curtain on its wearable BioSticker, which aims to do more than simply collect clinical-grade vital signs and raw activity data. Using a combination of different sensors, it can track and identify distinct symptomatic episodes such as coughing, sneezing or vomiting. With a 30-day battery life, the BioSticker is … Read more
May 14, 2020 Dubbed SweynTooth, the collection of 12 publicly available exploits could be used to wirelessly crash a device and stop it from functioning or access central user features. The Agency said it is not aware of any adverse events related to these vulnerabilities. “Medical devices are becoming increasingly connected, and connected devices have … Read more
May 12, 2020 Under its original policy, FDA said it would not object to the development and use of serological tests without FDA review or authorization so long as the tests were validated and the agency had been notified that the company planned to market the tests. More than 100 antibody tests were marketed under … Read more