MedTech News
.................... by Andrew Celentano
Tandem Diabetes Care Receives Health Canada Approvals for t:slim X2 Insulin Pump
Tandem Diabetes Care has announced receipt of Health Canada approval of a license amendment for the t:slim X2 insulin pump with Control-IQ+ automated insulin delivery technology.
Tandem’s Mobi pump wins FDA clearance for 7-day tubeless wearable set
Tandem Diabetes Care (Nasdaq: TNDM) has secured an FDA clearance for a tubeless version of its miniaturized automated insulin delivery system.
Bracco and Avicenna.AI Announce FDA Clearance for UPTUNITY™ | Aneurysm, a New AI-Enabled Software for Brain Aneurysm Detection and Assessment
Developed in collaboration with Avicenna.AI, the newly FDA-cleared technology introduces UPTUNITY™, Bracco’s new portfolio of AI-enabled clinical decision support solutions.
Virtuoso Surgical’s bladder cancer resection robot secures FDA de novo authorisation
De novo authorisation for Virtuoso’s system follows its assignation of FDA breakthrough designation in September 2025.
FDA clears Bechtel Medical’s wound therapy system
Bechtel Medical intends to initiate a limited commercial rollout of the device in December 2026.
Medtronic, Contego claim new FDA nods for Neuroguard carotid stent
Contego Medical has secured new green lights from the FDA for its Neuroguard IEP stent and filter system, broadening its use in treating narrowed carotid arteries.
Centinel Spine® Receives MDR Certification for prodisc® L Lumbar Total Disc Replacement System
Centinel Spine®, LLC (“the Company”), a commercial-stage medical technology company focused exclusively on total disc replacement (TDR) and advancing motion-preserving solutions for the cervical and lumbar spine, today announced that its prodisc L Lumbar TDR system has received certification under the European Union Medical Device Regulation (MDR).
Abbott Receives FDA Approval and CE Mark for UltiSynq Defibrillation Lead
Abbott has received U.S. Food and Drug Administration (FDA) approval and CE Mark for the UltiSynq defibrillation lead, which is designed to deliver both conduction system pacing and defibrillation therapy, providing an additional lead option in the U.S. and EU for patients who are candidates for both conduction system pacing and defibrillation protection.