The French and German governments have just announced a major project to develop a digital platform for the early detection of new respiratory pathogen epidemics, and then monitor their spread and inform decisions on appropriate counter measures. The COVID-19 crisis has confirmed the need for a resilient multi-stakeholder surveillance and control system to manage current and future epidemics or pandemics.
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
A team at South Korea’s Gwangju Institute of Science and Technology (GIST) developed a new technique to easily visualize viruses using an optical microscope.
Four months after debuting W1 health watch at Arab Health 2022, Masimo Corp. reported a limited release of the consumer version of the device in the U.S. to 10,000 users on a first come-first served basis. The wrist-worn device, which measures oxygen saturation, pulse rate, perfusion index, pleth variability index and respiration rate, also counts steps and detects falls.
The lawsuit filed by Illumina Inc., against officials with Guardant Health Inc., revolves around trade secrets allegedly misappropriated by two former Illumina employees, including Helmy Eltoukhy, who helped to found Guardant while still employed at Illumina. Among other things, the complaint states that Eltoukhy had asked another Illumina employee about research that ultimately ended up in the hands of Guardant despite that the document in question was explicitly labeled as confidential and for internal use only.
PARIS – Biospectal SA has just closed a $4.3 million seed round to scale its Optibp smartphone blood pressure monitoring application and data platform technology worldwide.
TORONTO – Audioptics Medical Inc. has raised a C$1.9 million (US$1.5 million) seed investment round for development of a device that visualizes and assesses the structures of the middle ear to help patients avoid surgery for conductive hearing loss. Audioptics Medical CEO Dan MacDougall told BioWorld the investment marks a major step in his company’s path towards commercial development of its flagship product, the Ossiview Middle Ear Imaging system.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
The U.S. FDA finally granted Abbott Laboratories' Freestyle Libre 2 clearance as an integrated continuous glucose monitor (iCGM) for adults and children age 4 and older with diabetes. Abbott received CE mark for the device more than 18 months ago and discussed its submission to the FDA in an earnings call over a year ago. Abbott expects the device to be available at pharmacies and durable medical equipment suppliers within weeks.
