t:slim X2 Insulin Pump First to Receive New ACE Pump Classification by FDA
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.
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.
“This new classification of the t:slim X2 pump provides more flexibility
for us as we make improvements to current products, create new products,
and collaborate with best-in-class companies in the development of
future automated insulin delivery systems,” said Kim Blickenstaff,
president and CEO of Tandem Diabetes Care. “This further establishes the
role Tandem Diabetes Care has taken as a key innovator in the insulin
pump industry, having launched the first touchscreen pump in the United
States, the first pump capable of remote feature updates, the first pump
approved as iCGM compatible, and now the first in this new interoperable
pump category.”
“The FDA’s special controls set a new standard in our industry and
define another component of the regulatory process for future automated
insulin delivery systems,” said John Sheridan, executive vice president
and COO of Tandem Diabetes Care. “Having the t:slim X2 pump approved
with this new designation, combined with its ability for remote software
updates, will enable more efficient and predictable development of new
systems with current and future technology partners, and allow faster
delivery of new innovations to our customers.”
About the t:slim X2 Insulin Pump
The simple-to-use t:slim X2 insulin pump includes advanced features like
a large color touchscreen, rechargeable battery, Bluetooth®
wireless technology, USB connectivity and watertight construction (IPX7)1.
It is capable of remote software updates using a personal computer,
offering the potential for users to access new features as they meet
necessary regulatory requirements.2 The t:slim X2 Pump is up
to 38 percent smaller than other insulin pumps and holds up to 300 units
of insulin.3
About ACE Pumps
According to the FDA, ACE pumps are devices intended for the infusion of
drugs into a patient. The ACE pump may include basal and bolus drug
delivery at set or variable rates. ACE pumps are designed to reliably
and securely communicate with compatible external devices, such as
automated drug dosing systems, to allow drug delivery commands to be
received, executed, and confirmed. ACE pumps are intended to be used
both alone and in conjunction with digitally connected medical devices
for the purpose of drug delivery.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company dedicated to improving the lives of people
with diabetes through relentless innovation and revolutionary customer
experience. The Company takes an innovative, user-centric approach to
the design, development and commercialization of products for people
with diabetes who use insulin. Tandem’s flagship product, the t:slim X2
insulin pump, is capable of remote software updates using a personal
computer and features integrated continuous glucose monitoring. Tandem
is based in San Diego, California.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslimX2 and
$TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
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Tandem Diabetes Care on LinkedIn at www.linkedin.com/company/TandemDiabetes.
Tandem Diabetes Care is a registered trademark and t:slim X2 is a
trademark of Tandem Diabetes Care, Inc. The Bluetooth word mark and
logos are registered trademarks owned by Bluetooth SIG, Inc. and any use
of such marks by Tandem Diabetes Care, Inc. is under license.
Forward Looking Statement
This press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things: the anticipated future growth of the
Company; the expectation that this new classification provides the
Company with more flexibility in the product development process
generally; the potential that the Company will enter into additional
third-party collaborations; and that this new classification will result
in more efficient and predictable development of new systems. These
statements are subject to numerous risks and uncertainties, including:
the Company’s ability to continue to meet the special controls
associated with ACE pumps; the Company’s ability to complete the
development of future products, including the successful completion of
current and planned clinical studies; that the results of clinical
studies will support future regulatory submissions of new products;
market acceptance of the Company’s existing products and products under
development by physicians and people with diabetes; the Company’s
ability to meet increasing operational and infrastructure requirements
from higher customer interest and a larger base of existing customers;
as well as other risks identified in our most recent Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q, and other documents that
we file with the Securities and Exchange Commission. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release. Tandem
undertakes no obligation to update or review any forward-looking
statement in this press release because of new information, future
events or other factors.
| 1 | Tested to a depth of 3 feet for 30 minutes | |
| 2 |
Future algorithms and integrations with compatible devices may not be developed, and would be subject to applicable regulatory requirements. A prescription and additional training may be required to access certain future software updates. Charges may apply. |
|
| 3 |
38 percent smaller than MiniMed 630G and 670G and at least 28 percent smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data on file, Tandem Diabetes Care. |
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