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Medical Devices
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Terumo recalls thoracic stent grafts after 3 patient deaths
Terumo initiated voluntary recall of 7,000 Relay Pro stent grafts across 43 countries after delivery system failures in 4 cases.
Read full articleFDA approvals up in 2026 but taking substantially longer
FDA authorized more devices in H1 2026 vs last year, but average PMA approval time jumped to 599 days from 402 days.
Read full articleSTARMED first to win FDA clearance for thyroid RFA system
STARMED achieved historic FDA 510(k) clearance for first radiofrequency ablation system specifically for benign thyroid nodules.
Read full articleSpiro Robotics gets FDA nod for guided intubation system
FDA cleared Spiro-VISTA, first handheld device combining video laryngoscopy with steerable navigation for tracheal intubation.
Read full articleJenaValve Trilogy shows strong results in AR, LVAD patients
New data from ALIGN-AR study and LVAD registry demonstrate Trilogy TAVR system's effectiveness in aortic regurgitation patients.
Read full articleTerumo recalls thoracic stent grafts after 3 patient deaths
Terumo initiated voluntary recall of 7,000 Relay Pro stent grafts across 43 countries after delivery system failures in 4 cases.
Read full articleFDA approvals up in 2026 but taking substantially longer
FDA authorized more devices in H1 2026 vs last year, but average PMA approval time jumped to 599 days from 402 days.
Read full articleSTARMED first to win FDA clearance for thyroid RFA system
STARMED achieved historic FDA 510(k) clearance for first radiofrequency ablation system specifically for benign thyroid nodules.
Read full articleSpiro Robotics gets FDA nod for guided intubation system
FDA cleared Spiro-VISTA, first handheld device combining video laryngoscopy with steerable navigation for tracheal intubation.
Read full articleJenaValve Trilogy shows strong results in AR, LVAD patients
New data from ALIGN-AR study and LVAD registry demonstrate Trilogy TAVR system's effectiveness in aortic regurgitation patients.
Read full articleStay ahead of Medical Devices in 3 minutes a day.
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