Insulet (Nasdaq:PODD) today reported first-quarter financial results that came in well ahead of the consensus forecast on Wall Street. Shares of PODD ticked up 5% to $175.79 before the market opened today. However, at midday, shares were down 8.2% at $153.78 apiece, potentially in response to scrutiny over U.S. trends and new patient starts. The […]
Drug-Device Combinations
Embecta ‘disappointed’ with Q2 results that fell below expectations, cuts 2026 guidance
Embecta (Nasdaq:EMBC) today reported second-quarter financial results that fell shy of expectations on Wall Street. The BD Diabetes spinoff attributed shortcomings to increased competitive dynamics and softness in overall market volumes in the U.S. Its international business performed in line with expectations, however. Shares of EMBC fell 43% to $5.29 apiece before the market opened […]
Tandem makes t:slim X2 insulin pump available with Dexcom G7 15 Day CGM
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it made its t:slim X2 insulin pump available with the Dexcom (Nasdaq:DXCM) G7 15 Day CGM. On LinkedIn today, the San Diego-based automated insulin delivery system developer said: “It’s here! The Tandem t:slim X2 insulin pump now integrates with the Dexcom G7 15 Day CGM system!” The t:slim X2, […]
Insulet initiates study of fully closed-loop insulin delivery in type 2 diabetes
Insulet (Nasdaq:PODD) announced today that it enrolled the first participant in a study of its fully closed-loop automated insulin delivery system for type 2 diabetes. Acton, Massachusetts-based Insulet aims to bring a fully closed-loop (FCL) system to the type 2 diabetes population to further improve glycemic outcomes with less burden for users across diverse settings. […]
Senseonics announces $80M public offering
Senseonics (NYSE:SENS) today announced that it commenced an underwritten public offering to sell $80 million in common stock. The offering includes common stock and, for certain investors, pre-funded warrants to purchase common stock. Germantown, Maryland-based Senseonics expects to grant underwriters a 30-day option to purchase. up to an additional 15% of the total number of […]
Dexcom stock dips after hours despite Q1 beats, 15% sales growth
Dexcom (Nasdaq:DXCM) today posted first-quarter results that came in ahead of the Wall Street forecast. Shares of DXCM fell nearly 6% to $55.99 apiece in post-market trading today. The San Diego-based continuous glucose monitor (CGM) developer reported profits. of $199.5 million. That equals 51¢ per share on sales of $1.19 billion for the three months […]
FDA says Insulet Omnipod 5 recall is serious after 476 device reports, issue is potentially undetectable by user
The FDA says last month’s recall of Insulet (Nasdaq:PODD) Omnipod 5 insulin pump pods has been identified as its most serious type. According to the FDA, such a recall may cause serious injury or death with continued use. Insulet announced on March 12 that it initiated a voluntary medical device correction for specific lots of […]
MiniMed earns Health Canada nod for Simplera Sync sensor with 780G pump for type 2 diabetes
MiniMed (Nasdaq:MMED) announced today that it received approval in Canada for new software for its MiniMed 780G system. Health Canada authorization allows the company to deliver the MiniMed 780G automated insulin delivery system with both its Guardian 4 and Simplera Sync continuous glucose monitor (CGM) sensors. Additionally, the system now has compatibility with Fiasp insulin […]
Tandem wins FDA clearance for automated insulin delivery in pregnant women with type 1 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy. The FDA cleared the company’s Control-IQ AID technology for use in pregnancy complicated by type 1 diabetes mellitus. Control-IQ+ powers both of Tandem’s available t:slim X2 and Mobi AID systems. San Diego-based Tandem says t:slim X2 […]
MiniMed not aware of compromises, doesn’t expect impact from Medtronic cyber breach
MiniMed (Nasdaq:MMED) issued an SEC filing stating that it doesn’t expect to be affected by the recent cybersecurity breach at parent company Medtronic. On April 24, Medtronic issued a statement saying that it determined that an unauthorized party accessed data in certain corporate IT systems. The company identified no impact to products, patient safety, connections to […]
