Categories fda

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‘It’s almost like placing an IV’: Brain monitoring electrode receives FDA 510(k) clearance

An FDA pathway that’s greased the gears for COVID-19 vaccines and drugs has paved the way for something else: a new take on electroencephalography (EEG), the established brain-monitoring technique in which metallic electrodes are placed on the scalp to measure the brain’s electrical activity.  On May 17, DC-based startup iCE […]

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Johnson & Johnson’s COVID-19 vaccine is 85% effective against severe cases, and 66% effective overall per trial data

Another COVID-19 vaccine is almost ready to begin being distributed — a single-shot inoculation made by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. The company just released an efficacy report based on data from its Phase 3 trial, which found that the new vaccine is 66% effective overall in preventing moderate […]

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LabCorp COVID-19 test kit has just been approved for sale over-the-counter

LabCorp has now become the first company to receive approval to sell its COVID-19 test kit over-the-counter without a prescription, according to a statement from the company. One of the largest diagnostics testing companies in the U.S., LabCorp could be a significant competitor to companies like EverlyWell, which received approvals […]

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Mammoth Biosciences’s CRISPR-based COVID-19 test receives NIH funding through RADx program

CRISPR tech startup Mammoth Biosciences is among the companies that revealed backing from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) program on Friday. Mammoth received a contract to scale up its CRISPR-based SARS-CoV-2 diagnostic test in order to help address the testing shortages across the U.S. […]

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Genomics startup Helix receives $33 million in NIH funding to scale COVID-19 testing

The U.S. National Institutes of Health (NIH) is revealing the first beneficiaries of its Rapid Acceleration of Diagnostics (RADx) program, and San Mateo-based Helix is on the receiving end of $33 million in federal funding as a result. Helix is a health tech startup founded in 2015 that focuses on […]

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Cue Health’s portable, fast COVID-19 test gains FDA emergency approval

Fresh off a $100 million Series C funding round, molecular diagnostics startup Cue Health has more good news — it has received an Emergency Use Authorization (EUA) for its rapid, point-of-care COVID-19 test. The company got a $13 million grant from BARDA in March to help it scale its development […]

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Taika is building a better coffee through natural chemistry and adaptogens

So, an eight-year product veteran from Facebook and an internationally renowned barista walk into a coffee bar… It’s not a joke. It’s the origin story for Taika, a new startup that’s aiming to bring natural stimulants to the masses through its juiced up coffee-beverages. The two co-founders, Michael Sharon, an […]

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LetsGetChecked raises $71 million as COVID-19 epidemic makes home-testing increasingly vital

As the country wrestles with the COVID-19 epidemic, home health testing, checkups and diagnostics have never been more important and companies like LetsGetChecked are filling a void left in a U.S. healthcare system consumed by the outbreak. The surge in demand for the company’s services has led to an equal […]

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KlearNow raises $16 million to bring customs clearance industry into the digital age

Customs is the sieve of international supply chains. And yet despite its critical role, clearing customs for freight brokers can be a slow and opaque process reliant on manual data entry and prone to errors. Silicon Valley-based KlearNow has developed a platform that aims to bring customs clearance into the […]

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GM delivers first ventilators under 30,000-unit government contract

Ventilators assembled by GM and Ventec Life Systems were delivered to hospitals Thursday night with more making their way to facilities today and through the weekend, the first in a 30,000-unit order with the U.S. government. The deliveries, which went to hospitals in Chicago and Olympia Fields, Ill., are a […]