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Posts Tagged ‘food and drug administration’

Venture-backed Celularity receives FDA approval for early trials of a new cell therapy for COVID-19

Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19. The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer” (NK) cell therapies to boost ...

FDA introduces a new program to expedite deployment of potential coronavirus treatments

The U.S. Food and Drug Administration (FDA) announced a new program today that’s designed to foster close collaboration between public and private organizations in order to “bring coronavirus treatments to market as fast as possible,” according to U.S. Department of Health & Human Services Secretary Alex Azar in a press release. The program, dubbed the ...

Prisma Health develops FDA-authorized 3D-printed device that lets a single ventilator treat four patients

The impending shortage of ventilators for U.S. hospitals is likely already a crisis, but will become even more dire as the number of patients with COVID-19 that are suffering from severe symptoms and require hospitalization grows. That’s why a simple piece of hardware newly approved by the FDA for emergency use – and available free ...

Mesa Biotech gains emergency FDA approval for rapid, point-of-care COVID-19 test

The U.S. Food and Drug Administration (FDA) is making use of its Emergency Use Authorization (EUA) powers to expand the pool of available COVID-19 testing resources in the U.S., and now you can add another rapid test that delivers results in just 30 minutes to the list. Mesa’s test is also small enough to be ...

Hydroxychloroquine, chloroquine and other potential COVID-19 treatments explained

During two of this week’s White House briefings, President Trump referred specifically to two potential treatments that have been identified by medical researchers and clinicians, and that have undergone various degrees of investigation and testing in the ongoing fight against the global coronavirus pandemic. It’s important to note upfront that regardless of what you may ...

With echoes of Theranos, Truvian Sciences revives the dream of low-cost, accessible blood tests

A little over a year after the dissolution of the once high-flying blood testing startup Theranos, another startup has raised over $27 million to breathe new life into the vision of bringing low-cost blood tests to point-of-care medical facilities. Unlike Theranos, Truvian Sciences is not claiming that most of its blood tests do not need ...

Scanwell Health launches smartphone tests for UTIs in partnership with Lemonaid Health

Companies continue to refine digital diagnostic tools for in-home healthcare at a rapid clip and the latest to launch is an at-home test for urinary tract infections from the Los Angeles-based startup Scanwell Health. The company was founded by Stephen Chen, who literally grew up in the diagnostics testing business. His family had built one ...

Impossible Foods goes to the grocery store

After receiving approval from the Food and Drug Administration, Impossible Foods has cleared the last regulatory hurdle it faced to rolling out in grocery stores. The company is targeting a September release of Impossible products on grocery store shelves, joining its competitor Beyond Meat on grocery store shelves. The news comes as the company said ...

Medivis gets FDA approval for its augmented reality surgical planning toolkit

Augmented reality is coming to the operating room theater sooner than anyone may have predicted. Medivis, which launched its product suite earlier this year, has now received approvals from the Food and Drug Administration and will begin rolling out its service in hospitals around the country. The SurgicalAR platform is a visualization tool that guides ...

Helping children overcome their mobility challenges, Trexo Robotics gets a Y Combinator boost

Manmeet Maggu and Rahul Udasi didn’t know it when they met at the University of Waterloo 11 years ago, but the bond they forged in late-night study sessions as roommates has helped drive their work to create an exoskeleton that provides mobility for children with disabilities. The fruit of that labor is Trexo Robotics, which ...