As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients. Read More
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China. Read More
Jerusalem-based Brainsway Ltd. had good news to report with the presentation of positive data from a multicenter study evaluating its deep transcranial magnetic stimulation (dTMS) system as an aid in smoking cessation. Read More
Sen. Amy Klobuchar (D-Minn.) has posted new legislation that would bolster antitrust enforcement and deter anticompetitive behavior in the private sector, but the bill faces considerable opposition. Glenn Lammi of the Washington Legal Foundation told BioWorld that the legislation would blunt investment in the life sciences due to provisions that would make the possession of a patent an indication of legally actionable anticompetitive behavior. Read More
LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai. Read More
Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artio Medical, Dermtech, Horiba Medical, Oncosec. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Extracts, Arima Genomics, Asuragen, Aytu Bioscience, Becton, Dickinson and Co., Biogx, Blue Earth Diagnostics, Bracco Imaging, Caredx, Cefaly, Co-Diagnostics, Datos, Geacom, Haselmeier, Healthcall, Heiq Materials, IDbyDNA, Illumina, Impulse Dynamics, Invo Bioscience, Nobio, Pharmajet, Qiagen, Roche, Supergum, Tandem Diabetes Care, Twist, West China Hospital, XCR Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Neural Fiber Optic Systems, Medx Health. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics. Read More
Keeping you up to date on recent developments in oncology, including: Cancer mortality rates falling, but incidence rising among women; Camouflage for better nano-treatments for cervical cancer; Deep learning may boost glial segmentation studies. Read More
