t:slim X2 Insulin Pump First to Receive New ACE Pump Classification by FDA
“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
“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
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
About
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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
| 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. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190214005947/en/
Source:
Media Contact:
Steve Sabicer
714-907-6264
ssabicer@thesabicergroup.com
Investor Contact:
Susan Morrison
858-366-6900 x7005
IR@tandemdiabetes.com