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Coalition of 31 states calls on FDA to regulate flavored e-cigarettes
New York and 30 other states and territories have urged the FDA regulate e-cigarette flavors and marketing aimed at kids.
FDA clears Natural Cycles birth control app for use with wearables
Natural Cycles said the approval makes it the “world’s first wearable birth control.”
Bose built the first FDA-cleared hearing aids that won't require a doctor's visit
Bose has unveiled its first hearing aids, and they're the first in the US that don't require a doctor's visit or prescription — you can buy SoundControl directly.
FDA approves the first smart insulin pen cap to help with dosing
Bigfoot Unity works with Abbott's FreeStyle Libre 2 glucose monitoring system.
FDA authorizes cheap rapid at-home COVID-19 tests
Cheap, rapid at-home COVID-19 tests will be available soon without a prescription.
FDA clears first AI device to spot hidden signs of COVID-19
The FDA has cleared an AI-powered armband for emergency use that can identify signs of COVID-19 in asymptomatic individuals using light sensors and a computer processor.
How the world went from no COVID vaccines to two in under a year
The next stage involves testing the vaccine on animals. By November, just four months after beginning phase III trials, the company demonstrated its vaccine to be 94 percent effective in preventing COVID infection.
FDA clears emergency use of lab-made antibodies to treat COVID-19
The FDA has cleared the use of Regeneron's lab-made antibodies to treat COVID-19, but only in some cases.
Amazon Pharmacy delivers discount prescriptions to Prime members
Amazon Pharmacy is an online pharmacy offering two-day shipping and deep discounts for Prime members.
FDA clears Apple Watch app that helps treat PTSD-related nightmares
The FDA has approved sale of an Apple Watch app, NightWare, that helps sleep for people with PTSD-related nightmares.
Fitbit's Sense smartwatch begins receiving ECG app update
One of the Fitbit Sense’s most notable features is its ability to assess heart rhythms for atrial fibrillation through an ECG app. When the FDA cleared that app for use back in September, Fitbit said it would be available for users this month. Now, the fitness wearable maker has revealed that the ECG app has started rolling out in the US and select regions in Asia and Europe.
Fitbit gets FDA clearance for its Sense smartwatch and ECG app
Fitbit's Sense smartwatch will be able to detect atrial fibrillation when it arrives in October.
FDA approves first automated insulin system for kids
Testing blood sugar frequently and administering insulin as needed throughout the day isn’t easy, especially if the individual with diabetes is a young child who can’t do it on their own yet. Now, there’s an FDA-sanctioned device that could make things easier for parents and caregivers: The agency has approved Medtronic’s MiniMed 770G System for use in children aged 2 to 6 with type 1 diabetes. It can be used for individuals 2 years old and above, but it’s the first of its kind that can be legally marketed towards kids in that age range.
Abbott's 15-minute, $5 COVID-19 test gets FDA authorization
The BinaxNow $5 COVID-19 test works a lot like a home pregnancy test and can return results in 15 minutes. It's paired with an app, Navica, that intends to give users a "temporary digital health pass" to go with negative results.
Telehealth got a huge boost from COVID-19. Now what?
During the height of the coronavirus pandemic, venturing outside in New York felt like preparing for battle. “Cancer doesn’t stop for COVID,” said Dr. Mara Weinstein, assistant professor of dermatology at the University of Rochester Medical Center. Dr. Weinstein told Engadget that she is still seeing patients every day in upstate New York.
First FDA-approved prescription video game will help treat kids with ADHD
It’s entitled EndeavorRx, and while it’s not exactly comparable to your favorite AAA video games, it was designed to improve the attention function of kids with ADHD.
Fitbit's COVID-19 ventilator gets emergency FDA approval
Fitbit has received the FDA's emergency approval for its ventilator, but it doesn't have clients just yet.
Eight US companies will manufacture NASA’s COVID-19 ventilator
Eight US companies will manufacture the ventilator designed by NASA's Jet Propulsion Laboratory and fast-tracked by the FDA.
An iPhone and an ultrasound wand could help doctors monitor COVID-19 remotely
Welcome to a new way to monitor COVID-19. The beauty of Butterfly's approach to telemedicine is that you don't have to know a thing about ultrasound systems to use it.
FDA approves a rapid COVID-19 test that uses CRISPR
Sherlock Biosciences has received an Emergency Use Authorization (EUA) from the FDA for a rapid COVID-19 test that uses CRISPR technology. Sherlock’s CRISPR SARS-CoV-2 test uses a CRISPR molecule to detect the genetic signature of the virus. The kit, which uses a nasal swab or bronchoalveolar lavage (BAL) specimen, is designed for use in laboratories authorized to perform high complexity tests.
