Tandem Diabetes (TNDM) Gets FDA Nod for Tandem Mobi System
Tandem Diabetes Care, Inc TNDM recently received FDA clearance for its durable automated insulin delivery system (AID), Tandem Mobi. The pump is indicated to be used by people with type 1 diabetes aged six and up and is operated by a smartphone through a mobile application.
Impressively small Tandem Mobi expands the company’s portfolio of diabetes solutions, laying out new options in wearability, the flexibility to disconnect and full phone control. This solidifies TNDM’s commitment to bringing wider choices along with the proven benefits of its technology to more people living with diabetes.
Key Features of the Tandem Mobi System
Nearly half the size of the t:slim X2 pump, the miniature Tandem Mobi can be clipped to clothing, worn on the body with an adhesive sleeve (sold separately) and seamlessly fit in a coin pocket. The system features a 200-unit insulin cartridge and an on-pump button that provides an alternative option for phone control for bolusing insulin.
Image Source: Zacks Investment Research
At its core, Tandem Mobi is powered by Control IQ — the advanced hybrid closed-loop technology that also features in Tandem Diabetes’ differentiated t:slim X2 insulin pump. The system is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, including a new five-inch tubing option made just for Mobi.
Additional features include wireless charging and remote software updates via a compatible smartphone. Tandem Mobi is designed to be used as part of an AID system.
More in the News
The Tandem Mobi insulin pump is intended for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. The pump can securely communicate with compatible, digitally-connected devices, including automated insulin dosing software, to receive, execute and confirm commands from these devices.
The pump is intended for a single patient, home use and requires a prescription. A limited release of Tandem Mobi is expected to start in late 2023 with full commercial availability planned in early 2024.
Industry Prospects
The global AID system market was valued at $749.2 million in 2022 and is expected to witness a CAGR of 9.8% by 2030.
Another Development
In January 2023, TNDM acquired Switzerland-based privately-held AMF Medical SA, the developer of the Sigi Patch Pump. The acquisition bodes well for the company’s strategic vision to include a patch pump in its portfolio of differentiated offerings.
Price Performance
In the past six months, shares of Tandem Diabetes have dropped 32.8% against the industry’s 5% rise.
Zacks Rank and Key Picks
Tandem Diabetes currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Haemonetics HAE, Zimmer Biomet ZBH and SiBone SIBN. While Haemonetics sports a Zacks Rank #1 (Strong Buy), Zimmer Biomet and SiBone each carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics’ stock has risen 32.6% in the past year. The Zacks Consensus Estimate for Haemonetics’ earnings per share (EPS) has increased from $3.55 to $3.56 for fiscal 2024 and remained constant at $3.96 for fiscal 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, the average surprise being 12.21%. In the last reported quarter, the company registered an earnings surprise of 13.24%.
The Zacks Consensus Estimate for Zimmer Biomet’s 2023 EPS has remained constant at $7.45 in the past 30 days. Shares of the company have improved 39.8% in the past year against the industry’s 21.3% decline.
ZBH’s earnings beat estimates in each of the trailing four quarters, the average surprise being 7.38%. In the last reported quarter, the company recorded an earnings surprise of 13.86%.
The Zacks Consensus Estimate for SiBone’s 2023 loss per share has narrowed from $1.44 to $1.42 in the past 30 days. SIBN shares have improved 104.8% in the past year compared with the industry’s 14.8% growth.
SiBone’s earnings beat estimates in three of the trailing four quarters and missed the same in one, the average surprise being 11.11%. In the last reported quarter, the company recorded an earnings surprise of 21.95%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Haemonetics Corporation (HAE) : Free Stock Analysis Report
Zimmer Biomet Holdings, Inc. (ZBH) : Free Stock Analysis Report
Tandem Diabetes Care, Inc. (TNDM) : Free Stock Analysis Report
SiBone (SIBN) : Free Stock Analysis Report
