Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system. Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts–based Insulet said it represents the first CE-marked tubeless hybrid closed loop system The latest-generation Omnipod 5 […]
Patient Monitoring
FDA clears Medtronic’s Linq II for kids 2 and up
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for pediatric use of its Linq II insertable cardiac monitor (ICM) system. The Linq II ICM initially received FDA clearance in 2020 for patients aged 21 or older. The clearance announced today allows for use in pediatric patients over 2 years old who have heart […]
HeartBeam picks up patent for 12-lead ECG patch
HeartBeam (Nasdaq:BEAT) announced today that the U.S. Patent and Trademark Office issued a patent for its 12-lead electrocardiogram (ECG) patch. Santa Clara, California–based HeartBeam designed its ECG patch monitor for detecting acute coronary syndrome (ACS) and cardiac arrhythmia. The company said in a news release that the granted patent builds on its portfolio, enabling 12-lead […]
The 10 largest medtech employers — and what their employees really think
Employees of the 10 largest medtech employers are happy to be a part of companies having a positive impact on patient populations. That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor. Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 […]
FDA clears Medtronic RespArray patient monitor for procedural sedation and medical-surgical units
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its RespArray patient monitor. Fridley, Minnesota-based Medtronic designed RespArray for procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography. RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Algorithms help to detect respiratory compromise early and reduce […]
Senseonics CFO is leaving
Senseonics (NYSE:SENS) announced that its chief financial officer, Nick Tressler, is transitioning from his position. Tressler’s transition is effective as of yesterday, Sept. 1, 2022. Senseonics selected VP of Finance, Rick Sullivan, to succeed Tressler as CFO. Get the full story at our sister site, Drug Delivery Business News.
Study backs next-gen Medtronic MiniMed 780G insulin pump
Medtronic (NYSE:MDT) today announced positive results from a study of its next-generation MiniMed 780G automated insulin delivery system. Results from the ADAPT study, published in The Lancet Diabetes & Endocrinology, demonstrated improved glycemic control and treatment satisfaction among users of MiniMed 780G. The MiniMed 780G system is available in more than 60 countries. It is currently […]
Integra’s CereLink ICP Monitor recall is Class I
The FDA has labeled the recall of the Integra LifeSciences (Nasdaq:IART) CereLink system as Class I, the most serious kind. Integra designed its CereLink system for intracranial pressure (ICP) monitoring. Last week, the company announced an immediate, voluntary global product removal of the systems. An FDA notice classified the U.S. recall, initiated by Integra on […]
Dexcom names Jake Leach chief operating officer
Dexcom (Nasdaq:DXCM) announced that it promoted chief technology officer Jake Leach to the chief operating officer (COO) role. Leach served as CTO since 2018, leading the company’s research, product development, product management and engineering departments. He joined the company in 2004 to lead the development of sensor electronics for its first commercial continuous glucose monitor […]
Masimo launches health-tracking watch for consumers
Masimo (Nasdaq:MASI) announced today that it began the full market release of its Masimo W1 health watch for consumer use. Irvine, California-based Masimo designed its W1 watch to offer accurate, continuous measurements and insightful health data. The wrist-worn wearable builds on the company’s personal, lifestyle-friendly designs for non-invasive blood parameter monitoring. For the first time […]
Medtronic, BioIntelliSense partner on distribution of wearable patient monitoring device
Medtronic (NYSE:MDT) announced today that it partnered with BioIntelliSense on distribution rights for the BioButton device. BioButton, a multi-paremter wearable for continuous, connected monitoring, measures up to 1,440 vital sign measurements per day. Its measurements include skin temperature, respiratory rate at rest, and heart rate at rest. The device, combined with advanced analytics, helps clinicians […]