The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE. Read More
Exo Imaging Inc. closed a $40 million series B+ funding round that is earmarked to help with the development of a hand-held ultrasound device and cloud-based workflow software platform. The funding follows a series B round in August 2019 that reeled in $35 million and brings the company’s total raise to nearly $100 million. Read More
LONDON – European scale-up of an artificial intelligence tool for stratifying and personalizing treatment of COVID-19 patients according to the type of complications they are likely to experience will get underway in September, following initial validation. The tool, developed by researchers at the Hospital Clinic Barcelona, Spain, was ‘trained’ on more than a trillion anonymized data points retrieved from the clinic’s electronic health records system. Read More
The COVID-19 pandemic has had an enormous impact on elective and nonessential procedures, and with them the medical device companies they depend on, but early signs of recovery are encouraging, according to Raghav Tangri, of (DRG), which is part of Clarivate. That said, Tangri told BioWorld that while the second quarter is expected to be the most strongly impacted period this year, the speed of recovery will depend on a number of factors, including the possibility of a second wave of the coronavirus outbreak and how soon a vaccine is available. Read More
Despite two significant coronavirus outbreaks in the last two decades that killed hundreds of people, dominated international headlines, and grabbed millions in research dollars, SARS-CoV-2 still caught researchers, national scientific advisors, pharmaceutical companies flatfooted when it emerged in late 2019. Why? Read More
PERTH, Australia – Sydney-based Cochlear Ltd. reported its first loss in 25 years due to the COVID-19 pandemic and a patent battle loss in the U.S. For fiscal year 2020, which ended June 30, Cochlear reported a AU$238 million (US$170 million) loss in sales, down 186% from last year’s profit of AU$276 million. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Medical Technologies, Fitbit, Medtronic, Myriad Genetics, Nanodropper, Pear Therapeutics, Serve You Rx, Todos Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetna, Hemosphere, Merit Medical. Read More
Keeping you up to date on recent developments in neurology, including: Novasignal’s Lucid robotic system reveals insights into COVID-19; Sensing eye mask developed to improve data capture in neuro studies; Multiple sclerosis’ early days; How antidepressants inhibit fibrosis. Read More
