FDA

FDA confirms at-home coronavirus tests are in pipeline

FDA confirms at-home coronavirus tests are in pipeline

The FDA is working with coronavirus test developers on at-home kits, that might eventually allow COVID-19 diagnostics to be performed at home, though the public health agency warns that there are still barriers to any such system launching. While the US Food and Drug Administration has now issued 34 of the so-called emergency use authorizations for coronavirus diagnostics, it confirmed, so far no at-home COVID-19 tests have been given the green-light.

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This COVID-19 saliva test is some coronavirus good news

This COVID-19 saliva test is some coronavirus good news

A new coronavirus test that doesn't require uncomfortable throat or nasal swabs has been given the go-ahead by the FDA, as tools to gage the COVID-19 pandemic continue to use the agency's emergency authorization process. So far, testing for detection of the SARS-CoV-2 virus have relied on a swab being pushed into the nose or throat, something which is both uncomfortable for the patient and potentially risky for the healthcare worker.

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FDA approves second N95 mask decontamination system for hospitals

FDA approves second N95 mask decontamination system for hospitals

The Food and Drug Administration has approved the second system designed for decontaminating used N95 respirators. The technology helps address the shortage of these vital masks used by healthcare workers to protect themselves from exposure to the novel coronavirus. The new emergency use authorization joins a similar one granted to Ohio company Battelle in late March.

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Coronavirus blood filtration system gets FDA nod for emergency use

Coronavirus blood filtration system gets FDA nod for emergency use

The FDA has given emergency authorization to a blood purification system for coronavirus treatment, that promises to filter out potentially lethal proteins in a patient's bloodstream that can surge during COVID-19 infection. The system aims to avoid what's known as a "cytokine storm," where a build-up can lead to rapidly progressive shock, respiratory and organ failure, and even death.

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FDA warns dangerous chlorine dioxide products won’t cure COVID-19

FDA warns dangerous chlorine dioxide products won’t cure COVID-19

The FDA is back with yet another warning about the 'Miracle Mineral Solution' sold by the Genesis II Church of Health and Healing, this time advising the public not to consume this substance under the belief that it will cure or prevent COVID-19. As the agency has repeatedly stated over past years, Miracle Mineral Solution is chlorine dioxide, a bleaching agent that can cause serious health problems.

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FDA issues stern COVID-19 serological test warning

FDA issues stern COVID-19 serological test warning

The FDA has warned COVID-19 serological test-makers not to overstate the usefulness - or claim federal approval - of their products, cautioning that it may still be too early for such diagnostics to be meaningful. Unlike more widespread test processes, which look for the coronavirus itself in samples taken from patients, serological tests instead look for the body's immune response to an infection.

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FDA expands on 2 coronavirus treatment trials

FDA expands on 2 coronavirus treatment trials

The FDA announced expansions of clinical trials and potential for expanded access programs for two treatments for COVID-19. The FDA announced this latest national effort to bring blood-related therapies for the novel coronavirus (COVID-19) global pandemic this afternoon. The two potential treatment products are called convalescent plasma and hyperimmune globulin.

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That 2-minute coronavirus test FDA approval was a “misunderstanding”

That 2-minute coronavirus test FDA approval was a “misunderstanding”

After claiming they'd received FDA authorization for a 2-minute coronavirus antibody test earlier this week, a company called Bodysphere just changed their tune. They made clear in their press release released at the tail end of March, 2020, that the Food and Drug Administration had approved their coronavirus (COVID-19) testing kit. It all seemed too good to be true. Turns out, it was.

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FDA says throw this popular heartburn medicine away over cancer risk

FDA says throw this popular heartburn medicine away over cancer risk

A popular heartburn drug has been yanked from shelves, and the FDA has warned it should be thrown out of medicine cabinets, after testing revealed that it could contain a cancer-causing carcinogen. While the US Food and Drug Administration says it only discovered dangerous levels of NDMA in a small number of samples, it's enough to warrant a complete lock-down on production.

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FDA reportedly approves two-minute coronavirus antibody testing kit [Update: Hoax?]

FDA reportedly approves two-minute coronavirus antibody testing kit [Update: Hoax?]

The Food and Drug Administration has approved a coronavirus testing kit from Bodysphere, one that can detect antibodies related to the virus in only two minutes, the company announced today. The test will be deployed in states around the country, enabling healthcare facilities to test for signs that the patient had contracted the virus at some point. The testing kit is only intended for use by medical professionals, however. [Update: This announcement could well be a hoax, it's been reported; see the update at the end of the article]

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FDA approves Battelle tech for decontaminating N95 respirators

FDA approves Battelle tech for decontaminating N95 respirators

An important type of face mask called an N95 respirator is in critically short supply at the moment, putting medical workers in many countries at risk of contracting the novel coronavirus. Unlike surgical masks and ordinary paper masks, an N95 respirator features a tight fit and can filter out the majority of particles in the air. In light of the shortage, the FDA has granted emergency use authorization to new technology that can decontaminate used N95 respirators.

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FDA: Don’t blame us for coronavirus test “roadblock”

FDA: Don’t blame us for coronavirus test “roadblock”

The FDA is pushing back at accusations that it has been a bottleneck in coronavirus testing, dismissing criticisms that COVID-19 specific tests have been delayed because of its oversight. US testing numbers amid the coronavirus pandemic have become a topic of huge controversy in recent weeks, with suggestions that uncertainty about just how many Americans might be infected have left healthcare providers floundering and unprepared.

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