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FDA issues 510(k) clearance for twiist insulin system
DEKA Research & Development has received 510(k) clearance from the US Food and Drug Administration (FDA) for the twiist automated insulin delivery (AID) system. The device is designed to ...
Fact Check: Insulin cap for Medicare unaffected by Trump order on prescription drug costs
A provision about insulin in the Inflation Reduction Act is conflated with a 2022 executive order by former President Joe ...
Newsweek15d
Gavin Newsom Underestimated Deadline for Bold Insulin Plan by Years
Neither clinical trials nor an application for federal approval from the Food and Drug Administration (FDA) are underway, meaning it's highly unlikely the state-manufactured insulin will be ...
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Newsom committed California to making its own insulin. It’s at least a year behind his schedule
Inc., the nonprofit drug manufacturer contracted to produce insulin for California, has not started clinical trials or applied for approval from the federal Food and Drug Administration, both of which ...
pharmaphorum1d
Automated insulin dosing app Tidepool Loop FDA-cleared
has announced that the US Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in those six years old ...
devdiscourse3d
From Drug Approvals to Global Health Funding: Key Updates in Health Sector
This article highlights recent developments in healthcare, including the U.S. FDA's approval of Alzheimer's and diabetes ...
insider.si.edu1mon
Recombinant DNA and the Birth of Biotech Recombinant Drugs
it was time to bring the recombinant insulin to the market. In 1982 Food and Drug Administration approved Humulin, Eli Lily’s recombinant insulin made from Genentech’s specially modified bacteria. It ...
Beta Bionics targets $114M IPO raise to fund insulin pump development
The company estimates that its install base surpassed 15,000 by the end of last year, leading to sales of more than $20 ...
5 Key Insights On Dexcom’s Stelo And Abbott’s Lingo Glucose Monitors
Continuous glucose monitors like Dexcom's Stelo and Abbott's Lingo are small, wearable devices that track blood glucose ...
KHOU 1110d
Yes, Trump rescinded Biden's order to lower prescription drug costs for people on Medicare and Medicaid
The final proposed model would have had Medicare pay less for drugs that receive accelerated approvals from the Food and Drug ...
KHOU 117d
No, Trump did not get rid of Medicare’s $35 insulin cap
On the first day of his second term, President Donald Trump signed an executive order revoking dozens of the Biden administration ... model capping insulin costs at $35 per month for people on ...