Tag: Insulin pump
Mattel launches Barbie with Type 1 diabetes, CGM
July 9, 2025HME News Staff
EL SEGUNDO, Calif. – Mattel is debuting the first Barbie doll with Type 1 diabetes (T1D). This addition enables more children to see themselves reflected in Barbie and encourages doll play that extends beyond a child’s own lived experience, thereby fostering a greater sense of inclusion and empathy – all pillars of the Barbie brand’s mission, the company says. “Introducing a Barbie doll with Type 1 diabetes marks an important step in our commitment to inclusivity and...
Tandem sees sales increase in Q1
May 1, 2025HME News Staff
SAN DIEGO – Tandem Diabetes Care reported that worldwide sales increased to $234.4 million for its first quarter 2025, an increase of 22% compared to the same quarter in 2024. Pump sales in the U.S. grew by 19% on a GAAP basis and 17% on a non-GAAP basis, on strong shipment growth and average selling price improvement, with the company shipping more than 17,000 pumps in the U.S. and 11,000 outside the U.S. “The strength of our first quarter performance was driven by more than 20% worldwide...
Medtronic seeks FDA clearance for pump
April 24, 2025HME News Staff
GALWAY, Ireland – Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform. The submissions included a 510(k) application for its MiniMed 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard...
Medtronic sensor receives FDA clearance
April 22, 2025HME News Staff
GALWAY, Ireland – Medtronic has received clearance from the U.S. Food and Drug Administration for the Simplera Sync sensor for use with the MiniMed 780G system. With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor. The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard...
Beta Bionics announces IPO pricing
January 30, 2025HME News Staff
IRVINE, Calif. – Beta Bionics has announced the pricing of its upsized initial public offering of 12 million shares of common stock at a price to the public of $17 per share. The gross proceeds to Beta Bionics from the offering, before deducting underwriting discounts and commissions and offering expenses are expected to be $204 million. In addition, the underwriters have a 30-day option to purchase up to an additional 1.8 million shares of common stock at the public offering price, less underwriting...
PharmaSens adds two to board
November 6, 2024HME News Staff
BIEL/BIENNE, Switzerland – PharmaSens, a developer of insulin patch pumps for people with diabetes, has appointed Robert A. Gabbay, MD, PhD, FACP and James L. Peterson to its board of directors. The Swiss company is developing an insulin delivery platform and is working to bring to patients the first all-in-one wearable patch device integrating both insulin delivery and continuous glucose sensing. "Welcoming Dr. Bob Gabbay and James Peterson to our board is a great honor and represents...
Tandem offers update on recall
August 21, 2024HME News Staff
SAN DIEGO – Tandem Diabetes Care on Aug. 9 emailed notices to customers impacted by a recall of its Apple OS t:connect mobile app. The recall, issued in March, relates to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery, causing the insulin pump to shut down sooner than expected. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release. Tandem strongly...
Tandem integrates with Dexcom
May 29, 2024HME News Staff
SAN DIEGO – The Tandem Mobi insulin pump with Control-IQ technology is now fully compatible with both the Dexcom G7 and Dexcom G6 continuous glucose monitoring systems (CGMs). Tandem Mobi, an automated delivery system (AID), launched in the United States earlier this year. “Choice is a hallmark of our offerings, and we’ve proven this commitment with the expansion of our insulin pump portfolio and extended CGM compatibilities,” said John Sheridan, president and CEO of Tandem...
Insulet’s Omnipod fuels growth
February 23, 2024HME News Staff
ACTON, Mass. – Insulet reported full year 2023 revenues $1.7 billion, up 30% compared to 2022. Fourth quarter 2023 revenue was $509.8 million, up nearly 38%. Total Omnipod revenue was $501 million; of that, US Omnipod revenue was $394.6 million, an increase of nearly 43%. “2023 was another transformational year for Insulet,” said Jim Hollingshead, president & CEO. “The rapid adoption of Omnipod 5 helped fuel our eighth consecutive year of more than 20% constant currency revenue...
Tandem Mobi gets FDA approval
July 13, 2023HME News Staff
SAN DIEGO – Tandem Diabetes Care has received U.S. Food and Drug Administration clearance for the Tandem Mobi insulin pump for people with diabetes age 6 and up. The Tandem Mobi is fully controllable from a mobile app. “Testing the limits of pump miniaturization, Tandem Mobi joins the t:slim X2 pump in our family of insulin delivery solutions bringing new options in wearability, the flexibility to disconnect, and full phone control,” said John Sheridan, president and CEO. “Through...