fda – Impact Lab

Coronavirus, Healthcare, Medical Breakthrough, Science & Technology News

First at-home COVID-19 testing kit authorized by the FDA

May 12, 2020

LabCorp, which makes the test, is prioritizing health care workers and first responders

The US Food and Drug Administration has issued the first authorization for an at-home COVID-19 test kit. LabCorp, the diagnostics company producing the tests, says it will give first access to health care workers and first responders.

With this test, people who are eligible can swab their nose to collect a fluid sample, but they will still need to send it to a lab for testing. Self-sampling sidesteps the need for a clinician to perform the test, reducing their exposure to symptomatic patients. It also frees up more personal protective equipment, which is in short supply. The test costs $119.

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Analysis, Coronavirus, Healthcare, Science & Technology News

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

March 29, 2020

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 NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. Its size and that it can produce either a positive result in just five minutes or a negative one in under 15 mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.

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

Food, government, Science & Technology News, Shopping

The FDA Tells the Food Industry to Change How It Uses ‘Expiration’ Dates

June 2, 2019

The Food and Drug Administration is going after food waste with a new effort to make sure we don’t throw out groceries until they’re absolutely inedible.

On Thursday, the agency issued a letter to the food industry at large, throwing its support behind a growing trend to almost universally adopt a “Best if Used By” date label on products. At the same time, it’s also reminding the public that most foods can still be perfectly safe to eat if they’re past the marked date, even if they’re not necessarily quite as tasty anymore. The moves are part of a larger effort by the FDA to drastically cut down on America’s food waste problem.

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Healthcare, Medical Breakthrough, Wearables

The world’s first “artificial pancreas” already hit the market in 2017

January 18, 2019

Good news for people with type 1 diabetes. In case you missed it, the first “artificial pancreas” was approved by the U.S. Food and Drug Administration (FDA) and is now ready for prime time.

Innovative medical technology company Medtronic’s MiniMed 670G is the first device to combine an automated glucose monitor and an insulin pump. It administers an accurate amount of insulin as needed and will also automatically shut off insulin release when a drop in sugar levels is detected. This minimizes the risks of taking too much or too little insulin, both of which can have fatal consequences.

Medtronic describes the MiniMed 670G as “the first hybrid closed loop system in the world.” The device only requires patients to input mealtime carbohydrates and calibrate the sensors periodically, allowing them to live life more freely. It also helps them sleep well through the night and wake up with healthy glucose levels.

Continue reading… “The world’s first “artificial pancreas” already hit the market in 2017″

Biotech, Children, DNA, Science & Technology News

Decoding your baby’s DNA: It can be done. But should it be?

April 27, 2018

Maverick Coltrin was diagnosed with pyridoxine-dependent epilepsy shortly after he was born. He now gets checkups to make sure his seizures are under control and that he’s still healthy. (Kent Nishimura / Los Angeles Times)

Maverick Coltrin entered the world a seemingly healthy 8-pound boy. But within a week, he was having seizures that doctors could neither explain nor control. They warned that he would probably die within a few months.

“I remember my world just came crashing down,” said his mother, Kara Coltrin, 24.

Continue reading… “Decoding your baby’s DNA: It can be done. But should it be?”

cutting edge, Great New Product, Science & Technology News, Wearables

FDA approves world’s 1st contact lenses that darken in sunlight

April 24, 2018

Contact lenses that automatically darken when the wearer goes outside are cleared to hit the market after the innovation got a green light from the U.S. Food and Drug Administration this month.

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Biotech, Healthcare, Medical Breakthrough, Stem cells

Newly FDA-approved platform will rapidly “manufacture” stem cells to repair our bodies

January 31, 2018

Doctors at the Mayo Clinic have received FDA approval for a platform that can manufacture stem cells by the billions in just days, in contrast to previous methods of making stem cells that took months.

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Analysis, Big Problems, Healthcare, Latest Trend, Robotics, Science & Technology News

Robotic surgery involved in 144 deaths in the U.S. since 2000

July 27, 2015

Between 2000 and 2013, robotic surgeons were involved in the deaths of 144 people, according to records kept by the FDA. There are some forms of robotic surgery that are much riskier than others: the death rate for head, neck, and cardiothoracic surgery is almost 10 times higher than for other forms of surgery.

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Analysis, Business, Health & Fitness, Science & Technology News

FDA vouchers encourage drug companies to focus on neglected diseases

May 19, 2014

FDA vouchers were created as an incentive to encourage drug companies to work on medicines for neglected diseases.

In March, when the Food and Drug Administration gave the OK to a new treatment for a parasitic disease called leishmaniasis, the Canadian company that owns the medicine got something that’s quite likely to prove even more valuable than U.S. sales of the drug will ever be.

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Analysis, Health & Fitness, Latest Trend, Science & Technology News

Top 5 emerging medical technologies to watch in 2014

March 26, 2014

Robotic check-ups

Medical technology companies are focusing more than ever on products that deliver cheaper, faster, more efficient patient care. They are also making inroads with U.S. Food & Drug Administration regulators to re-engineer the complex review and approval process for new medical devices.

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Great New Product, Great Videos, Health & Fitness, Science & Technology News

FDA approves PillCam, an alternative to the traditional colonoscopy

February 12, 2014

PillCam

The FDA has approved the PillCam for use as an alternative for patients who are unable to have a complete colonoscopy. The pill-shaped capsule has a camera on both ends. It navigates through your intestines over an eight-hour period, taking high-speed images that are sent to a device worn by a patient that are later examined by a doctor. (Video)

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Business, Health & Fitness, Science & Technology News

FDA orders 23andMe to stop selling genetic tests

November 27, 2013

23andMe has been advertising that its tests offer diagnostic information for a variety of human conditions.

23andMe, the pioneering genetic screening service, has been told by the FDA that it “must immediately discontinue” marketing of its Personal Genome Service (PGS) until it receives FDA authorization.

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