The U.S. FDA has expanded the emergency use authorization (EUA) for Rutgers University’s saliva-based COVID-19 test to include at-home use of Spectrum Solutions LLC’s SDNA-1000 whole saliva collection device, a development that underscores the need for wider testing as localities across the country emerge from lockdown and restart their economies. This is the first at-home option for saliva collection; the action comes just two weeks after the FDA authorized Laboratory Corp. of America’s polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19, to include the company’s Pixel self-collection kit for nasal samples. Read More
The U.S. FDA has issued an emergency use authorization (EUA) for an antigen test for the SARS-CoV-2 virus from Quidel Corp., of San Diego, that is more readily deployed than other diagnostic tests for the pathogen. Quidel’s offering can be used at the point of care (POC) and as a lab test. Read More
The FDA granted Setpoint Medical Corp. an investigational device exemption (IDE) approval to study its bioelectronic platform in rheumatoid arthritis (RA) patients. The Valencia, Calif.-based company expects to begin enrollment in a multicenter, double-blind, randomized, sham-controlled pivotal trial in patients with RA in the third quarter of 2020, Setpoint President and CEO Murthy Simhambhatla told BioWorld. Read More
ERTH, Australia – A recent study conducted at the University of Western Australia (UWA) Centre for Sleep Science shows that facial features analyzed from 3D photographs could predict the likelihood of having obstructive sleep apnea. Read More
HONG KONG – Blockchain technology usually is associated with digital currencies. However, it’s now emerging as an important platform for COVID-19 management. It’s been a focus in China, where a top-down approach is key to driving sectors and technology. Read More
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection. Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelmed, Aidoc, Avita Medical, Bellerophon Therapeutics, Datametrex AI, Fresenius Medical Care North America's Renal Therapies Group, Gaia, Inspire Medical Systems, Kc Wearable, Mevion Medical Systems, Orexo, Perkinelmer, Quest, Rochal Industries, Sanara Medtech, Seevix, Tearlab, Technopath, Telemedicine Clinic, Tissue Regenix, Unilabs, Zoll. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Aspenstate, Elemaster, Myriad, Visioncare. Read More
Keeping you up to date on recent developments in cardiology, including: Necklace used to detect abnormal heart rhythm; Link found between blood vessel inflammation, malfunctioning mitochondria; Liver-specific pre-eclampsia treatment is maternal-specific, as well. Read More
