Diabetes
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Newly public Beta Bionics reports sales surge; Dexcom hires CCO
Sales of Beta Bionics insulin pumps spiked 145% in the fourth quarter behind solid new patient starts. Elsewhere, former Masimo exec Jon Coleman joined Dexcom, and Sibionics’ CGM earned the CE mark.
By Nick Paul Taylor • March 28, 2025 -
Dexcom rejects claims of unauthorized device changes in FDA warning letter
A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its glucose sensors.
By Elise Reuter • March 27, 2025 -
Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.
By Elise Reuter • March 26, 2025 -
Q&A
Dexcom COO on 15-day glucose sensor, Type 2 coverage
Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and an FDA warning letter.
By Elise Reuter • March 25, 2025 -
Dexcom shares 15-day CGM data; Tandem posts Type 2 pivotal data
Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.
By Elise Reuter • March 20, 2025 -
Retrieved from Insulet on March 18, 2025
Insulet Chief Technology Officer Mark Field leaves
Amit Guliani, group vice president of software engineering, was named acting chief technology officer, effective immediately.
By Elise Reuter • March 18, 2025 -
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.
By Nick Paul Taylor • March 10, 2025 -
Illumina to lay off 96 San Diego employees
The latest job cuts at Illumina’s California headquarters are not part of a broad-based reduction, a company spokesperson said.
By Susan Kelly • Feb. 28, 2025 -
Tandem’s insulin pump tech wins FDA nod for Type 2 diabetes
Tandem is following competitor Insulet’s lead with the second automated insulin delivery system indicated for Type 2 diabetes.
By Elise Reuter • Feb. 27, 2025 -
Trump tariffs
Illumina placed on China’s unreliable entity list
Analysts said the move comes amid rising trade tensions with the U.S. and as Illumina faces stiff competition in China’s genome sequencing market.
By Susan Kelly • Feb. 5, 2025 -
Retrieved from Nasdaq on January 31, 2025
Beta Bionics raises $204M in IPO
The diabetes tech firm began trading this week and was valued at $966.2 million as of Thursday.
By Elise Reuter • Jan. 31, 2025 -
Neko Health raises $260M to expand body scan service, fund R&D
The company uses various medical devices to noninvasively check moles, the heart and more.
By Nick Paul Taylor • Jan. 28, 2025 -
Beta Bionics targets $114M IPO raise to fund insulin pump development
The company estimates that its install base surpassed 15,000 by the end of last year, leading to sales of more than $20 million in the fourth quarter.
By Nick Paul Taylor • Jan. 27, 2025 -
Abbott expects to launch first PFA device outside of the US this year
CEO Robert Ford also plans to expand sales of the company’s Lingo over-the-counter glucose sensors after a limited rollout.
By Elise Reuter • Jan. 22, 2025 -
JPM25 recap: Robotics, PFA and OTC glucose sensors in the spotlight
CEOs from Medtronic, Intuitive Surgical, Boston Scientific and Dexcom were on hand this week in San Francisco to discuss the year ahead at the J.P. Morgan Healthcare Conference.
By Susan Kelly • Jan. 17, 2025 -
Dexcom CEO talks Stelo sensor launch, OTC strategy
Kevin Sayer said at the J.P. Morgan Healthcare Conference that Dexcom also expects to release a 15-day glucose sensor in the second half of the year.
By Elise Reuter • Jan. 15, 2025 -
Beta Bionics, maker of ‘bionic pancreas,’ files for IPO
Beta Bionics did not disclose the number of shares it will offer or a price range.
By Elise Reuter • Jan. 8, 2025 -
Abbott, Dexcom settle glucose monitor patent lawsuits
The rival companies agreed not to sue each other for the next 10 years.
By Elise Reuter • Jan. 2, 2025 -
Robots, AI and PFA: The top medtech Q&As of 2024
From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.
By Ricky Zipp • Dec. 20, 2024 -
Dexcom adds generative AI to over-the-counter CGMs
Dexcom this week began rolling out the feature, which analyzes data to provide personalized tips and recommendations.
By Elise Reuter • Dec. 18, 2024 -
Embecta to cut 125 jobs after ending insulin patch pump
Embecta said its patch pump would require additions to be commercially competitive, and plans to use the funds saved to pay down debt.
By Elise Reuter • Dec. 6, 2024 -
Insulet awarded $452M in EOFlow patent fight
A jury found that competitor EOFlow and former executives misappropriated trade secrets for Insulet’s Omnipod insulin pumps.
By Elise Reuter • Dec. 5, 2024 -
Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs
About 7.4 million Americans with obesity could have insurance coverage for drugs like Wegovy if the Trump administration allows the rule to go into effect — at the cost of $40 billion to federal and state governments.
By Rebecca Pifer • Nov. 27, 2024 -
Embecta discontinues insulin patch pump development
CEO Dev Kurdikar said the decision may “come as a surprise” as Embecta just received FDA clearance for a patch pump, but the company “did not intend to do a full market launch of this product.”
By Elise Reuter • Nov. 26, 2024 -
Medtronic nets FDA nod for smart insulin pen app
The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.
By Susan Kelly • Nov. 22, 2024