Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse. Read More
LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma. Read More
The FDA is working toward a rewrite of its Quality Systems Regulation (QSR) and ISO 13485, the internationally recognized quality management standard, but that project has yet to produce a draft rule despite several years of effort. The FDA’s Vidya Gopal highlighted the differences between the two approaches to questions such as management responsibility and staff resources, just two of many differences that will prove difficult to reconcile in any regulatory harmonization effort. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is proposing refinements to the regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. Read More
PARIS – Royal Philips NV is working with the Spanish National Center for Cardiovascular Research (CNIC) on an ultrafast cardiac magnetic resonance imaging (MRI) protocol that could reduce scanning times to just a few minutes. Read More
The U.S. Office of Science and Technology Policy and the National Science Foundation are issuing a request for information to help the National Artificial Intelligence Research Resource Task Force in developing an implementation roadmap. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Edwards, Foodmarble, Inspiremd. Read More
