Glucotrack plans to file for an investigational device exemption in the second quarter, with hopes of starting a trial in the second half of 2026.
Glucotrack said it is ready to start a U.S. clinical trial following progress in other countries. Last year, the company shared results of a first-in-human trial of the device in Brazil.
During the five-day trial, the 10 participants had no procedure- or device-related adverse events, and the device demonstrated a mean absolute relative difference, or
The surgical navigation and robotics system is part of the company’s push to expand its share of the $15 billion cranial and spinal technologies market.
The Food and Drug Administration cleared Stealth AXiS for use in spine procedures in February. At the time, Medtronic said the underlying architecture could support cranial applications and ENT surgeries, pending 510(k) clearance. The FDA cleared the system in ENT procedures on March 16 and followed up with a 510(k) nod in cranial applications on
The company said it will seek an expanded indication for the left atrial appendage closure device after it met all safety and efficacy goals in the closely watched CHAMPION-AF study.
The Watchman device is currently approved by the Food and Drug Administration for use in patients with atrial fibrillation who cannot take long-term anticoagulants due to a high risk of bleeding.
The implant permanently closes off the left atrial appendage, a small pouch where blood can pool and form clots that can travel
Medtronic detailed plans to further study the blood pressure treatment while releasing additional data from the SPYRAL HTN trials that showed the procedure reduced hypertensive emergencies.
Medtronic’s renal denervation system delivers radiofrequency energy to ablate nerves around the renal arteries, disrupting overactive signaling between the kidneys and the brain to reduce blood pressure.
In October, the Centers for Medicare and Medicaid Services granted a national coverage determination for renal
Qdot Micro is temperature-controlled, contact force-sensing, RF catheter. The temperature control feature supports the use of higher radiofrequency power in short bursts, an approach that J&J sees as a way to improve efficacy without compromising safety. J&J published 12-month data on the effectiveness of the device in its Q-FFICIENCY study earlier this year.
The latest update, which was published in the Journal of Cardiovascular Electrophysiology, covers more data from the Q-FFICIENCY trial.
Penumbra first received approval for its Indigo system with its Lightning technology in 2020. Earlier this year, the company received clearance from the Food and Drug Administration for its newer Lightning Flash technology to remove large clots while minimizing blood loss.
An interim analysis of 150 patients treated with Penumbra’s Indigo system with 90-day follow-up was presented at the Vascular Interventional Advances Conference (VIVA) on Wednesday.
Penumbra’s STRIKE-PE study met both of
Siemens has been restructuring its diagnostics segment after telling investors last year that the business has been burdened by inflation, logistical and supply challenges and revenue hits due to the COVID-19 pandemic. The company announced it would cut costs by about 300 million euros by 2025.
Siemens is now moving forward with layoffs and plans to move some manufacturing overseas.
“Following an extensive review of the company’s diagnostics instrument manufacturing network for its laboratory