William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations. Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management. Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle […]
Abbott
Abbott increases guidance on strong Q1 results, reports progress on Volt PFA system
Abbott shares fell this today despite first-quarter results that came in ahead of the consensus forecast. Shares of ABT fell more than 3% to $105.81 apiece by later afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped slightly. The Abbott Park, Illinois-based medtech giant […]
Abbott has another serious LVAD recall
The FDA today labeled Abbott’s recall of some HeartMate II and HeartMate 3 left ventricular assist systems (LVAS) as Class I, the most serious kind. Abbott issued the recall of the HeartMate II and HeartMate 3 LVAS due to an issue known as extrinsic outflow graft obstruction (EOGO). The issue happens when biological material builds […]
Abbott warns on electromagnetic interference in some Aveir leadless pacemakers
Abbott recently issued an urgent field safety notice warning physicians that some Aveir leadless pacemakers may have electromagnetic interference. The Abbott Park, Illinois-based company warned that a subset of Aveir VR LSP112V devices manufactured with firmware version 19.05.00 have the potential for electromagnetic interference that could cause an inadvertent mode change. So far, the company […]
FDA approves Abbott TriClip TEER system
Abbott announced today that the FDA granted approval for its first-of-ts-kind TriClip transcatheter edge-to-edge repair (TEER) system. The expected approval comes after a February vote by an FDA panel that confirmed the system’s benefits outweighed its risks. Abbott designed TriClip to treat tricuspid regurgitation (TR), or a leaky tricuspid valve. Delivered through a vein in […]
Tandem Diabetes Care taps miniaturization and automation for its latest systems
Tandem Diabetes Care (Nasdaq:TNDM) EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so. In the space of about two months, Tandem announced continuous glucose monitor (CGM) integration with the latest-generation technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of […]
Abbott wins CE mark for insertable cardiac monitor
Abbott announced today that it received CE mark approval for its Assert-IQ insertable cardiac monitor (ICM). The ICM provides a new option for diagnostic evaluation and long-term monitoring in people experiencing abnormal heartbeats. It can detect hard-to-spot irregularities in heartbeats and help physicians determine the best treatment course. Assert-IQ received FDA clearance in May 2023, […]
The biggest diabetes tech news out of ATTD 2024
Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). In the 17th installment at the start of this month, some of the biggest names shared new studies and technologies set to advance the diabetes space. Dexcom, Abbott, Medtronic and more contributed on their end, while […]
Abbott is launching its latest Navitor TAVI system in the U.S.
Abbott is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official. In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of […]
Recall of Abbott HeartMate comms system is Class I
The FDA deemed a recall of the Abbott HeartMate Touch Communication System Class I, the most serious kind of recall. Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero […]
Abbott reports data that backs TAVR, LAA systems
Abbott today reported positive study data supporting its first-generation transcatheter aortic valve system and its Amplatzer Amulet. Abbott reported its outcomes at the Cardiovascular Research Technologies (CRT) 2024 meeting. The company first reported a pooled analysis from three clinical studies evaluating its Portico TAVR system, the predecessor to Navitor. It showed the safety and effectiveness […]