The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of … [Read More...] about FDA sends warning letter to Olympus over endoscope manufacturing
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FDA sends warning letter to Olympus over endoscope manufacturing
The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of … [Read More...] about FDA sends warning letter to Olympus over endoscope manufacturing
Kardium treats first patient in pulsed-field ablation study
Kardium announced today that it successfully treated the first patients in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system. Vancouver, British Columbia-based Kardium recently received FDA investigational device … [Read More...] about Kardium treats first patient in pulsed-field ablation study
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 … [Read More...] about Medtronic wins CE mark for Affera ablation system
FDA clears first device authorized under Safer Technologies Program
The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency's Safer Technologies Program. FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough … [Read More...] about FDA clears first device authorized under Safer Technologies Program
The biggest cardiology tech stories from ACC.23
Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific … [Read More...] about The biggest cardiology tech stories from ACC.23
Biosense Webster marks first cases with dual energy ablation tech
Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and … [Read More...] about Biosense Webster marks first cases with dual energy ablation tech
Medtronic pulsed-field ablation system exceeds safety goal in study
Medtronic (NYSE:MDT) announced today that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial. PulseSelect registered an adverse event rate of 0.7%. Medtronic said that marks one of the … [Read More...] about Medtronic pulsed-field ablation system exceeds safety goal in study
