Categories fda

11 posts

Auto Added by WPeMatico

Copy paste programmers

Researchers develop emergency ventilator based on resuscitation bags used in ambulances

The need for innovative solutions to address shortages in crucial medical equipment is greater than ever, and a new initiative from a global team of biomedical engineering experts is a perfect example. The team developed a way for resuscitation bags – common pieces of equipment carried by ambulances and paramedics […]

Copy paste programmers

Sleep apnea retrofit designed by doctors and engineers could help address ventilator shortage

The FDA has been working to adapt its policies and restrictions to respond to the growing need for unconventional solutions like shortages of medical equipment needed for treating COVID-19 patients. A group of doctors, engineers and medical researchers from UC Berkeley, UCSF and working hospitals has devised a creative solution […]

Copy paste programmers

ARCH Venture Partners raises $1.46 billion across two funds for biotech investing

Against a backdrop where the life-or-death consequences of biotechnology innovation are becoming increasingly apparent as the world races to develop vaccines and therapies to treat COVID-19, life sciences investor ARCH Venture Partners has raised $1.46 billion in funding to finance new tech development. The two funds, ARCH Venture Fund X […]

Copy paste programmers

Cue Health awarded $13 million government contract to develop portable, point-of-care COVID-19 test

Biotech startup Cue Health has secured a $13 million contract from the U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA), which will be used to speed the development and testing of a handheld molecular test that can detect the presence of the SARS-CoV-2 novel […]

Copy paste programmers

Ford, GE Healthcare to produce 50,000 ventilators by July using this tiny company’s design

Ford and GE Healthcare have licensed a ventilator design from Airon Corp and plan to produce as many as 50,000 of them at a Michigan factory by July as part of a broader effort to provide a critical medical device used to treat people with COVID-19. Ford will initially send a […]

Copy paste programmers

The FDA just okayed multiple 15-minute blood tests to screen for coronavirus, but there are caveats

On Thursday, the FDA amended their emergency policy around diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. Following on a change made March 16, the agency opened the door for a number of specific private entities and labs to develop and distribute tests that can provide results on […]

Copy paste programmers

How one company is fast-tracking development of potential plasma-based treatments for the coronavirus

Medical biotech company Emergent BioSolutions is one of the many health industry players turning its efforts toward addressing the current global coronavirus pandemic. Their work includes a two-pronged effort to pursue plasma-based treatments that could help lessen the impact of COVID-19 on healthcare systems, with a fast-tracked development timeline that […]

Copy paste programmers

FDA now allows treatment of life-threatening COVID-19 cases using blood from patients who have recovered

The U.S. Food and Drug Administration (FDA) has updated its rules around use of experimental treatments for the ongoing COVID-19 pandemic to include use of “convalescent plasma,” in cases where the patient’s life is seriously or immediately threatened. This isn’t an approval of the procedure as a certified treatment, but […]

Copy paste programmers

Healthcare startups Nurx and Carbon Health ship at-home COVID-19 test sample kits

Efforts to get at-home test kits for the COVID-19 coronavirus are ramping up quickly, and two more health industry startups are bringing their own products to market, with both Carbon Health and Nurx starting to ship their own in-home sample collection kits. Both of these new offerings are the same […]

Copy paste programmers

FDA testing coronavirus treatments, including chloroquine, plasma from recovered COVID-19 patients

U.S. Food and Drug Administration Commissioner Stephen Hahn addressed the ongoing work of the agency in terms of its work on potential treatments and vaccines for the COVID-19 coronavirus currently spreading globally. Despite a claim early in Thursday’s White House briefing on the pandemic by President Donald Trump that one […]