t:slim X2 Insulin Pump First to Receive New ACE Pump Classification by FDA
Tandem Diabetes Care, Inc. (TNDM)
Last tandem diabetes care, inc. earnings: 4/30 04:05 pm
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Source: Business Wire
SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has classified the t:slim X2™ insulin pump as the first in a new device category called Alternate Controller Enabled Infusion Pumps (ACE pumps). Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
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- Tandem Diabetes Care, Inc. (NASDAQ: TNDM) had its price target raised by analysts at Barclays PLC from $39.00 to $55.00. They now have an "overweight" rating on the stock.MarketBeat
- Earnings Update: Here's Why Analysts Just Lifted Their Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Price Target To US$43.57 [Yahoo! Finance]Yahoo! Finance
TNDM
Earnings
- 5/2/24 - Beat
TNDM
Sec Filings
- 5/2/24 - Form 10-Q
- 5/2/24 - Form 8-K
- 4/9/24 - Form ARS
- TNDM's page on the SEC website