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America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test

While many coronavirus tests provide results within hours or days, America's Food and Drug Administration "has authorized the emergency use" of a new rapid coronavirus test from medical device manufacturer Abbott that could results in less than 15 minutes, reports NBC News: The FDA told Abbott it authorized the test's use after determining that "it is reasonable to believe that your product may be effective in diagnosing COVID-19," based on the scientific evidence presented. The agency added tha...
Tags: Nbc News, America, Tech, Fda, Abbott, America s Food and Drug Administration


Some Researchers are Trying Mass Testing for Covid-19 Antibodies

An anonymous reader quotes Wired: Next week, blood banks across the Netherlands are set to begin a nationwide experiment. As donations arrive — about 7,000 of them per week is the norm — they'll be screened with the usual battery of tests that keep the blood supply safe, plus one more: a test for antibodies to SARS-CoV-2, the virus that causes Covid-19. Then, in a few weeks, another batch of samples will get the same test. And after that, depending on the numbers, there could be further rounds. ...
Tags: Tech, Netherlands, Fda, University of Notre Dame, Alex Perkins


A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current global pandemic has received emergency clearance for use by the U.S. Food and Drug Administration, and will begin production next week, with output of 50,000 per day possible starting next week. The new Abbott ID ...
Tags: Health, TC, Science, Medicine, Tech, United States, Healthcare, Food And Drug Administration, Fda, Biotech, Viruses, Infection, Abbott, Veterinary Medicine, U S Food and Drug Administration, Coronavirus


Trump orders GM to start ventilator production for COVID-19 amid contract dispute

President Donald Trump signed Friday a presidential directive ordering GM to produce ventilators and to prioritize federal contracts, just hours after the automaker announced plans to manufacture the critical medical equipment needed for patients suffering from COVID-19, disease caused by coronavirus. The order, made under the Defense Production Act, marks a sudden reversal by Trump, who has touted the efforts by GM and other manufacturers to try and ramp up production of ventilators and and per...
Tags: TC, White House, Tech, General Motors, Indiana, Automotive, New York Times, Fema, Mary Barra, Gm, Ohio, Fda, Donald Trump, Trump, Peter Navarro, Federal Emergency Management Agency


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 the spot in as little as 15 minutes – but there are some pretty big caveats to keep in mind as you hear about more of these coming to market. The tests, which are ‘serological,’ meaning t...
Tags: Health, TC, Science, Medicine, China, Singapore, Tech, Taiwan, United States, Fda, Viruses, Infection, China Taiwan, EUA, Fox Rothschild, Coronavirus


AR therapy for kids on autism spectrum may be headed for FDA approval

Google Glass technology repurposed to help children
Tags: Google, News, Trends, Google Glass, Fda, Augmented Reality, Emerging Tech


Garry Tan and Alexis Ohanian on how to survive these crazy days (and what to learn from them)

Garry Tan and Alexis Ohanian founded Initialized Capital roughly nine years ago and they’ve closed four funds since, including most recently in late 2018. That $225 million vehicle is roughly twice the size of their previous fund, but because of the coronavirus, the firm, and its portfolio companies — some of which include Opendoor, Instacart and Coinbase — could be facing a tougher road in 2020. Certainly, that’s true of nearly ever other venture firm and startup right now. To get a sense...
Tags: Google, Amazon, Florida, Tech, Peter Thiel, Reddit, Alexis Ohanian, Fda, Cannes Lions, Garry Tan, Bay Area, Flexport, Cabo San Lucas, Redwood City, Tan, Mehta


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 via source code and 3D-printing for hospitals – might be a key ingredient in helping minimize the strain on frontline response efforts. The Prisma Health VESper is a ...
Tags: Health, TC, Gadgets, Articles, Tech, Industrial Design, United States, 3d Printing, Food And Drug Administration, Fda, South Carolina, Emerging-technologies, Software Engineer, Sarah Farris, Coronavirus, COVID-19


Dyson and Gtech answer UK call for ventilator design and production to support COVID-19 response

Companies around the world are shifting production lines and business models to address the needs of governments and healthcare agencies in their efforts to slow the spread of COVID-19. Two companies answering that call are Dyson and Gtech, both of which are working on ventilator hardware, leveraging their experience building vacuums and other motor-driven airflow gadgets to spin up new designs and get them validated and produced as quickly as possible. Dyson, the globally recognized applianc...
Tags: Health, TC, Gadgets, UK, Hardware, Tech, United Kingdom, Healthcare, Boris Johnson, Fda, James Dyson, Dyson, UK Government, Grey, CNC, GTECH


3D-printing company Formlabs expects its swabs to receive FDA exemption

Formlabs, the privately held, Massachusetts-based 3D-printing company, will soon receive an exemption from the U.S. Food and Drug Administration for its swab designed for use in COVID-19 test kits, TechCrunch has learned. Global supply chains for test kit components including swabs and chemical reagents have hampered the ability of governments to increase testing to a point where they can adequately ascertain the scope of the outbreak of the novel coronavirus within their borders. “Yesterday we ...
Tags: Health, TC, Massachusetts, Tech, ISO, United States, 3d Printing, Italy, Disease, Ohio, Fda, Formlabs, U S Food and Drug Administration, Lakatos, David Lakatos, Lakatos Formlabs


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 towards 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 health care systems, with a fast-tracked development timeline that could see human clinical trials start as soon as this summer. The company is simultaneously working on two different therapeutic approaches,...
Tags: Health, TC, Science, Medicine, Tech, Food And Drug Administration, Fda, Manufacturing, Biotech, Infection, Head, Drug Development, Emergent, Saward, Coronavirus, COVID-19


Study behind updated FDA guidance shows self-swab tests are as effective as those done by clinicians

Earlier this week, the U.S. Food and Drug Administration (FDA) announced that it would be updating its guidance to allow self-swab tests for COVID-19, in which a patient collects a sample for their own nose for a health professional to test. On Wednesday, UnitedHealth Group revealed the results of a peer-reviewed large scale study that provided the science behind the decision to switch to the less-invasive sample collection method. The self-swab process doesn’t change where FDA-approved testing ...
Tags: Health, TC, Science, Washington, Tech, Healthcare, Fda, Infection, U S Food and Drug Administration FDA, University of Washington, UnitedHealth Group, Bill & Melinda Gates Foundation, Quest Diagnostics, Coronavirus, COVID-19


UK researchers develop new low-cost, rapid COVID-19 test that could even be used at home

A new type of test developed by UK researchers from the Brunel University London, Lancaster University and the University of Surrey can provide COVID-19 detection in as little as 30 minutes, using hand-held hardware that costs as little as £100 (around $120 USD) with individual swab sample kits that cost around $5 per person. The test is based on existing technology that has been used in the Philippines for testing viral spread in chickens, but it’s been adapted by researchers for use with COVID...
Tags: Health, TC, UK, Science, Medicine, China, Tech, Eu, European Union, Smartphone, Philippines, United Kingdom, Fda, Biotech, Software Testing, University of Surrey


New study casts doubt on hyrdoxychloroquine’s effectiveness in treating coronavirus

In a prime example of why President Trump shouldn’t be endorsing any unproven potential treatments for the novel coronavirus behind the current global pandemic, a new small-scale study by researchers in China indicates that the antimalarial drug hydroxychloroquine actually isn’t any more effective than standard, existing best practice for conventional care of patients with the virus. The study, which included 30 patients with a control of 15 who received no treatment, with the other half being t...
Tags: Health, TC, Science, Medicine, White House, China, Tech, President, Fda, Anthony Fauci, Trump, Phoenix, Fauci, Physician, Hydroxychloroquine, Coronavirus


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 rather an emergency clearance that applies only on a case-by-case basis, and only in extreme cases, as a means of helping further research being done into the possible efficacy ...
Tags: Health, TC, New York, Science, Medicine, White House, Tech, Disease, Fda, Andrew Cuomo, Blood, Director, Blood Donation, Governor, U S Food and Drug Administration FDA, Transfusion


Non-profit aims to get COVID-19 field tests, N95 masks and more to healthcare workers without markups

A new Sydney-based non-profit volunteer organization called RapidWard launches this week, with a focus on getting critical medical supplies from producers in China to healthcare professionals, doctors, hospitals and governments worldwide who need them. The group, founded by serial entrepreneur and advisor Milton Zhou, has ample supply chain experience and recognized the need for a solution that focused on establishing distribution pathways that eschew markups in order to make supplies available ...
Tags: Health, TC, Science, Biology, Australia, China, Articles, Tech, Ceo, United States, Korea, Sydney, Food And Drug Administration, Fda, Sustainable Energy, Medical Device


Nonprofit aims to get COVID-19 field tests, N95 masks and more to healthcare workers without markups

A new Sydney-based nonprofit volunteer organization called RapidWard launched this week, with a focus on getting critical medical supplies from producers in China to healthcare professionals, doctors, hospitals and governments worldwide who need them. The group, founded by serial entrepreneur and advisor Milton Zhou, has ample supply chain experience and recognized the need for a solution that focused on establishing distribution pathways that eschew markups in order to make supplies available a...
Tags: Health, TC, Science, Biology, Australia, China, Tech, United States, Korea, Sydney, Food And Drug Administration, Fda, Sustainable Energy, Medical Device, Biotechnology, Zhou


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 able to be used right at the frontline of care, including in clinics and hospitals, with multiple tests able to be run in parallel. Mesa’s rapid test follows one from Cepheid that was app...
Tags: Health, TC, Gadgets, Science, Tech, United States, Food And Drug Administration, Flu, Fda, Influenza, Amplifiers, U S Food and Drug Administration FDA, EUA, Mesa, Coronavirus, COVID-19


FDA updates COVID-19 testing guidelines to allow self-swab tests

The U.S. Food and Drug Administration (FDA) has updated its guidelines for COVID-19 testing procedures, in a bid to both make the process easier and less uncomfortable for patients, and to help limit the impact of testing on the supply of personal protective equipment (PPE) used by healthcare workers, including protective masks, face shields, gloves and gowns. The change means that people undertaking a test will be able to conduct their own swab, which will involve swabbing shallowly in their...
Tags: Health, TC, Science, Cdc, Articles, Tech, United States, Healthcare, Food And Drug Administration, Fda, Vice President, Centers For Disease Control And Prevention, Mike Pence, U S Food and Drug Administration FDA, Pence, Centers for Disease Control and Prevention CDC


Amazon Care to provide delivery and pick-up of at-home COVID-19 test sample kits in Seattle trial

Amazon is going to be working with a new research initiative backed in part by the Gates Foundation that will distribute at-home coronavirus assessment kits, and then deliver the collected samples to FDA-approved test facilities. Amazon Care, the health arm formed by Amazon initially for internal employee care, will be handling the delivery of the kits, as well as transportation of collected samples to the test labs, as first reported by CNBC. While the FDA updated its guidance just a few day...
Tags: Health, Amazon, TC, Transportation, Tech, United States, Food And Drug Administration, Flu, Fda, Viruses, Seattle, Cnbc, Gates Foundation, Greater Seattle, Amazon Care, Coronavirus


Non-profit launches COVID-19 treatment and vaccine tracker with daily updates

There are a lot of global efforts underway to develop vaccines and treatments for COVID-19, including repurposing of existing drugs approved for use in treating other forms of coronavirus and respiratory diseases. Many of these efforts are just entering into the formal clinical study phase, which will be required before any treatment is certified for widespread use in patients diagnosed with the illness. Vaccines are still likely at least a year out from approvals, though some have already enter...
Tags: Health, TC, Drugs, Tech, Vaccination, World Health Organization, Fda, Illness, Vaccine, Vaccines, Milken Institute, Drug Development, Coronavirus, COVID-19


Updated FDA COVID-19 testing guidelines specifically disallows at-home sample colllection

While a number of companies who currently offer at-home medical and health diagnostics had rushed to produce kits that would allow for self sample collection by people who passed a screening and believed they might have contracted the new coronavirus, the U.S. Food and Drug Administration (FDA) has updated its Emergency Use Authorization guidelines to private labs that specifically bar the use of at-home sample collection. This means startups including Everlywell, Carbon Health and Nurx will ...
Tags: Health, Startups, TC, Medicine, Tech, United States, Food And Drug Administration, Fda, U S Food and Drug Administration FDA, Cepheid, Nurx, EverlyWell, Carbon Health, Scanwell, COVID-19, Coronaviurs


YC startup Felix wants to replace antibiotics with programmable viruses

Right now the world is at war. But this is no ordinary war. It’s a fight with an organism so small we can only detect it through use of a microscope — and if we don’t stop it, it could kill millions of us in the next several decades. No, I’m not talking about COVID-19, though that organism is the one on everyone’s mind right now. I’m talking about antibiotic-resistant bacteria. You see, more than 700,000 people died globally from bacterial infections last year — 35,000 of them in the U.S. If we ...
Tags: Health, Startups, TC, Y Combinator, Science, Medicine, Articles, Tech, United States, United Nations, Disease, Jurassic Park, Fda, Biotech, Antibiotic Resistance, TechCrunch


Automakers, Tesla and SpaceX Explore Working on Ventilators

"Just had a long engineering discussion with Medtronic about state-of-the-art ventilators," Elon Musk tweeted on Saturday. Medtronic tweeted that the talks also involved Tesla. And TechCrunch notes that Musk tweeted on Friday that both Tesla and SpaceX employees are "working on ventilators...": His confirmation on Twitter that both of the companies he leads are working on ventilators comes a day after New York City Mayor Bill de Blasio made a direct plea to Musk to help alleviate a shortage at...
Tags: Spacex, Elon Musk, White House, New York City, Tech, Tesla, Ford, Shanghai, Bill De Blasio, Fda, Volkswagen, Musk, Medtronic, GM Volkswagen, Calif Sparks Nev


America's FDA Authorizes Fast Coronavirus Testing System

America's Food and Drug Administration has approved a coronavirus test from a company called Cepheid. It can deliver its results in about 45 minutes, "much faster than current tests that require a sample to be sent to a centralized lab, where results can take days," reports The Hill: The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for co...
Tags: America, Tech, Fda, Cepheid, America s Food and Drug Administration, David Persing Cepheid


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 shipping of their own in-home sample collection kits. Both of these new offerings are the same in terms of approach to testing: They deliver swab-based sample collection hardware that people can use at home to collect a mucus sample which they then ship back using including safety approved,...
Tags: Health, Startups, TC, Science, Medicine, Fsa, Tech, Carbon, Food And Drug Administration, HPV, Fda, HSA, Nurx, EverlyWell, Carbon Health, Eren Bali


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 have heard, from Trump or any other sources, no drugs or treatments have been proven as effective for either the prevention of...
Tags: Health, TC, Ebola, Science, France, White House, China, Tech, United States, President, Food And Drug Administration, Disease, Fda, Anthony Fauci, Malaria, Director


SpaceX and Tesla are ‘working on’ ventilators, Elon Musk says

Elon Musk tweeted Friday that Tesla and SpaceX employees are “working on ventilators” even though he doesn’t believe they will be needed. His confirmation on Twitter that both of the companies he leads are working on ventilators comes a day after New York City Mayor Bill de Blasio  made a direct plea to Musk to help alleviate a shortage at hospitals gearing up to combat COVID-19. Yes, we’re working on ventilators, even though I think they probably won’t be needed — Elon Musk (@elonmusk) March...
Tags: Health, Spacex, Elon Musk, White House, New York City, Tech, Tesla, Thailand, Automotive, Ford, Shanghai, Bill De Blasio, Fda, Volkswagen, Buffalo, De Blasio


Scanwell aims to launch at-home 15-minute coronavirus test, but it still needs FDA approval

At-home diagnostics startup Scanwell, which produces smartphone-based testing for UTIs, is working on getting at-home testing for the novel coronavirus into the hands of U.S. residents. The technology, which was developed by Chinese diagnostic technology company INNOVITA and has already been approved by China’s equivalent of the FDA and used by “millions” in China, can be taken at home in 15 minutes with the guidance of a medical professional via telehealth, and produces results in just hours. S...
Tags: Health, Startups, TC, New York, Hardware, California, Washington, China, Articles, Smartphone, United States, Food And Drug Administration, Fda, Biotechnology, Amplifiers, Washington California


Vaping additive blamed for outbreak produces ‘exceptionally toxic’ byproducts

The threat of vape lung seems to have receded to the distant past now that we are all facing the coronavirus, but new research has shed light on the nature of that much more limited epidemic. It turns out vitamin E acetate, the vape fluid additive until now merely associated with lung damage, converts into a toxic chemical cocktail when heated. That vitamin E acetate is not healthy to inhale is not a surprise; the chemical, which essentially had been used to dilute THC oil in cheap aftermarket v...
Tags: Health, Gadgets, Cdc, Tech, Royal College Of Surgeons, Fda, Vaping, Dublin, National Academy of Sciences, Wu, Dan Wu, Vape Lung, Vitamin E Acetate, Donal O'Shea



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