Tandem Mobi Now FDA Cleared as World’s First and Only Tubeless AID System with up to Seven Days of Wear

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Tandem Mobi Now FDA Cleared as World’s First and Only Tubeless AID System with up to Seven Days of Wear

2026-11-13 21:30 Last Updated At：21:40

SAN DIEGO--(BUSINESS WIRE)--Nov 13, 2026--

Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of Tandem Mobi for use as the world’s first and only tubeless automated insulin delivery system with up to 7 days of wear. 1 A new Tandem Mobi tubeless cartridge and infusion set converts the current Tandem Mobi pump into a tubeless device that can help simplify diabetes management with less frequent site changes, while offering the life-changing benefits of Control-IQ+ advanced hybrid closed-loop technology. The Tandem Mobi insulin pump is now cleared for tubeless and tubed insulin infusion options, making it the only pump that offers users the flexibility to choose the wear option that best meets their needs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112487071/en/

“The Tandem Mobi insulin pump was originally designed to make different wear options possible, which now includes a tubeless option with up to 7 days of wear 1,” said John Sheridan, president and chief executive officer. “This clearance of the Tandem Mobi tubeless cartridge and infusion set creates even more possibilities for people living with diabetes, expanding the number of ways to experience the proven benefits of our Control-IQ+ AID technology.”

Full commercial launch of the new tubeless cartridge and infusion set for Tandem Mobi is planned for the first half of 2027 in the United States. Customers with an in-warranty Tandem Mobi will not need a new insulin pump. Existing Tandem Mobi pumps are already compatible and can be used with the new tubeless infusion set and cartridge. Tandem will contact eligible customers with information about how to access the sets and cartridges when they are available.

Tandem Mobi Tubeless infusion sets and cartridges will be available exclusively through the pharmacy for customers with pharmacy benefits. Tandem currently estimates that pharmacy coverage for Tandem Mobi customers is available for approximately 50% of insured lives in the United States, with continued expansion expected ahead of launch and throughout 2027.

To learn more about Tandem Mobi Tubeless, visit https://www.tandemdiabetes.com/TandemMobiTubeless.

About the Tandem Mobi System

Tandem Mobi is the world’s smallest insulin pump that can be worn tubed or tubeless. Powered by Control-IQ+ technology, it uses CGM sensor values to predict glucose levels 30 minutes ahead and automatically adjust insulin as needed, with AutoBolus™ to help prevent hyperglycemia. Tandem Mobi can be used with compatible smartphones via the Tandem Mobi mobile app and supports multiple wear options including tubed and tubeless. Compatible with all Tandem infusion sets, the system allows users to temporarily disconnect for showering, hot tubs, or contact sports. It includes a 200-unit cartridge, inductive charging, water resistance (IP28), remote software updates, and wireless uploads of pump and therapy data to the cloud-based Tandem Source platform.

About Tandem Diabetes Care

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2™ insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.

Follow @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X.

Forward Looking Statements

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. These forward-looking statements relate to, among other things, the expected launch timeline and pharmacy availability. These statements are subject to numerous risks and uncertainties, including our ability to market, scale, and maintain the systems, personnel and infrastructure necessary to support the Tandem Mobi Tubeless infusion set and cartridge and the risk that we may encounter other challenges that may delay their availability. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents filed 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. Actual results could differ materially from those anticipated or projected in the forward-looking statements. 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.

Important Safety Information

RX ONLY. Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (the 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 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. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 2 years of age and greater. Control-IQ+ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ+ technology: Control-IQ+ technology is not a substitute for your own active diabetes management. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy. Control-IQ+ technology is intended for single patient use and requires a prescription.

WARNING: Control-IQ+ technology should not be used in anyone under the age of 2 years old. Control-IQ+ technology should also not be used in patients who require less than a total daily insulin dose of 5 units per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed in order for Control-IQ+ technology to operate safely.

Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

© 2026 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, Tandem logos, Control-IQ+, AutoBolus, Tandem Mobi, Tandem Source, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All other third-party marks are the property of their respective owners.

Pope says it's a "joy" to be home as Peru's Chiclayo welcomes back its former shepherd

CHICLAYO, Peru (AP) — Pope Leo XIV returned Friday to his beloved former diocese of Chiclayo and said it was a “joy” to be home, an emotional homecoming that underscored his love for his Peruvian flock and their pride that their shepherd now runs the Catholic Church.

The pontiff, known here as “Padre Roberto,” arrived at Chiclayo’s airport on the Pacific coast and immediately headed to a vast, dusty field outside Chiclayo for his first Mass on Peruvian soil. The Vatican estimated 1 million people had lined his motorcade route to the Mass and that 500,000 attended.

They cheered wildly when Leo arrived and looped through the crowd in his popemobile, under a scorching sun and temperatures of 31 C (87 F).

“What a joy it is to return to Chiclayo!” Leo said at the start of his homily. “It is a blessing for me to be with you once again,” he said, thanking the faithful especially for their prayers during his recent hospitalization for lung cancer. He declared that “with God’s help, I am overcoming” the health scare.

Chiclayo, population 700,000, is the commercial hub of Peru’s northern Pacific coast. But much of the world heard about it on the night of Leo’s election, May 8, 2025, when he gave Chiclayo a shoutout, in Spanish, from the loggia of St. Peter’s Basilica.

And on Friday, Chiclayo welcomed its former shepherd home.

"I’m elated. He has decided to return to Chiclayo and we have him here, with us -- home,” said Julie Albujar, who woke before dawn with her sister to travel to the Mass site, where they were tasked with taking the collection. “This is a party and it’s a sign of our faith and our love for the pope.”

The former Robert Prevost spent two decades as a missionary priest and bishop in Peru and credits the place and its people with teaching him how to be a shepherd. Pope Francis sent the Chicago-born Augustinian to take over as bishop of Chiclayo in 2014 and he stayed until Francis summoned him to Rome in 2023 to run the Vatican's bishops' office.

In hindsight, the 2023 transfer to Rome signaled that Francis saw in Prevost a potential successor, since the job is one of the most important in the church and would give Prevost the Vatican experience that many consider necessary to be a viable contender for the papacy.

But Prevost's heart is in Chiclayo, where he remains beloved for championing social justice issues and for his closeness to the people, especially poor people, during times of crisis. And he had quite a few during his tenure: COVID-19, devastating floods, and a surge of Venezuelan migrants as the humanitarian situation worsened there in 2018.

“I’m so glad he’s returning,” said Rolando Antonio Mendoza, who was selling posters bearing the pope’s image in front of the cathedral where Leo used to celebrate Mass. “Even though he’s now Pope Leo XIV, he hasn’t forgotten about his homeland.”

Nearby, the El Trebol restaurant proudly calls itself the restaurant of the pope and his image is displayed in framed photos of Prevost riding a horse, wading through the mud in rubber boots and celebrating his birthday with a cake.

A sign on his favorite table — No. 3 — with a view of the cathedral reads: “mesa bendita” – Spanish for blessed table. Like many other places around the city, the restaurant sells “Papaletas” or “Pop(e)sicles" with Leo's image in white chocolate.

Just a few steps from the restaurant, a life-size cardboard cutout of the pope now welcomes visitors to his former residence at the diocese, where an exhibit displays the amaranth purple, scarlet and white zucchettos, or skullcaps, that he wore as bishop, cardinal and now pope.

“I feel so happy about my work because the pope is Chiclayano,” said Cynthia Charrary, who was sweeping the streets near the city’s main square ahead of Leo’s arrival. “We want our city to be cleaner than ever.”

Ever since Leo touched down on Peruvian soil on Wednesday, the world has seen a very different pope.

Normally reserved and placid, the 71-year-old Leo has seemed at turns positively giddy and overwhelmed with emotion to the point of tears.

That was certainly the case on Thursday night when some 60,000 young Peruvians sang for him in the Lima stadium. It was also the case when he sang the national anthem at the presidential palace upon his arrival on Wednesday.

Leo has also sung along with popular songs and hymns, tapping his fingers to the beat on an armchair.

On other occasions, he has shown himself so relaxed and comfortable as to joke about his health. Speaking to Peruvian bishops, he joked about how some “doubting Thomases” didn’t think he’d make it because of his recent lung cancer surgery.

After the Mass, Leo's other main events of the day include a meeting with Chiclayo clergy and seminarians and a speech to the Catholic university where he served as chancellor during his years as bishop. The university is named for the 16th-century first archbishop of Lima, St. Turibius de Mogrovejo.

Leo is particularly devoted to Mogrovejo and in many ways modeled his ministry on his.

Mogrovejo is revered for having traveled long distances on horseback to be with his flock and for having defended the rights of Indigenous and enslaved peoples. He studied Quechua and Aymara and oversaw the printing of church teaching in these Indigenous languages, because he believed the faith had to be transmitted in a language people could understand.

The Rev. John Lydon, an Augustinian who lived with Leo in Peru for over 10 years, says his commitment to Peruvians, human rights and involving the lay faithful in the running of church initiatives was born during his stints first as a young missionary priest in Chulucanas, then Trujillo and finally as bishop in Chiclayo.

Lydon recalled that Leo first arrived in Peru in the mid-1980s and saw the period of the Shining Path terror campaign and the later crackdown by the authoritarian Fujimori regime. In the late 1990s, then-Rev. Prevost led a campaign to collect signatures to commemorate the 50th anniversary of the Universal Declaration of Human Rights.

“These are the kind of things that just mark his identity,” Lydon recalled.

———

Associated Press writer Mauricio Savarese contributed to this report from Lima.

Associated Press religion coverage receives support through the AP’s collaboration with The Conversation US, with funding from Lilly Endowment Inc. The AP is solely responsible for this content.

Tandem Mobi Now FDA Cleared as World’s First and Only Tubeless AID System with up to Seven Days of Wear

Business

Tandem Mobi Now FDA Cleared as World’s First and Only Tubeless AID System with up to Seven Days of Wear

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