Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held device works by directing precise wavelengths of visible light to the back of the throat and surrounding tissues. It is not yet available for sale in the U.S.
Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021.
Cognitoss, a resorbable bone graft in development by Locate Bio Ltd., received U.S. FDA breakthrough device designation for treating chronic osteomyelitis, a progressive, inflammatory bone infection. The graft uses a new class of composite collagen product combined with a dual-phasic release of antibiotics to prevent reinfection.
NEW DELHI – India, which has the highest incidence of tuberculosis (TB) in the world and the second highest of COVID-19, is looking to artificial intelligence (AI) to help detect and classify cases of both and lower the cost of diagnosis.
Perkinelmer Inc. is aiming to boost its infectious disease testing footprint with the acquisition of Oxford Immunotec Global plc for $591 million in cash. The purchase, reported Thursday, will allow Perkinelmer to expand its current offerings with solutions for tuberculosis (TB) detection. Perkinelmer shares (NYSE:PKI) hit a high of $162.16 Thursday morning, before closing at $160.53 – up 2.66% from the Wednesday’s close of $156.37.
HONG KONG – A research team at the Chinese University of Hong Kong (CUHK) has developed a fully automated, low-cost and rapid microrobotic diagnostic system that can be used with multiple pathogens, including COVID-19. The system works by integrating fluorescent microrobots with an external magnetic actuation system to detect pathogens in patient samples.
An international study led by Nanyang Technological University in Singapore has designed and synthesized broad-spectrum antimicrobial polymers (AMPs) and demonstrated the safety and efficacy of two such agents against multidrug-resistant (MDR) bacteria in mouse models of sepsis.
Hologic Inc. has gained approval from the U.S. FDA to add a diagnostic claim to its HIV type 1 viral load monitoring assay. This makes the Aptima HIV-1 Quant Dx assay the first dual-claim assay in the U.S., allowing both viral load monitoring and diagnosis. For laboratories that use the assay, the dual claim allows for consolidated testing on one automated platform, adding to efficiency.
Researchers at the University of California at San Francisco have developed a method to diagnose any known pathogen from any body fluid within a day – or, depending on the sequencing method, within a few hours. For an unknown pathogen, the method spits out its nearest known relative.
Day Zero Diagnostics Inc. has reported that data presented at IDWeek highlighted the promise of the company’s new class of diagnostics as it works toward its goal of detecting superbug infections quickly. The company ultimately is hoping to get regulatory signoffs in both the U.S. and Europe for its technology.