Tag Archives: FDA

CS Medical announces FDA 510(k) clearance of TD-8®

CS Medical is pleased to announce FDA 510(k) clearance of a new single-use, high-level disinfectant chemistry for the TD 100® Automated TEE Ultrasound Probe Disinfector. The FDA cleared high-level disinfectant TD-8 is OPA based and delivers a 5 minute high-level disinfection for TEE probes. The disinfectant will operate in the TD 100 identically to TD-5®, which was previously the only FDA ...

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Endoscope Cleaning Machine Tied to Superbugs Still Being Used

When going in for a medical procedure, you probably want to be certain the doctor’s instruments are clean. Following a recent turnabout by the U.S. Food and Drug Administration, that certainty may be a little harder to come by. Six months ago, the regulator said a machine tied by a U.S. Senate report to a deadly superbug outbreak should be taken off the market “as ...

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FDA clears Auris Surgical’s robotic endoscopy system

Auris Surgical Robotics has been flying under the radar, billing itself only as a “company based in Silicon Valley.” Founded by robotic surgery vet Dr. Frederic Moll, the company has won an FDA clearance for a robotic endoscopy system, which can potentially be used as a diagnostic or surgical tool. The FDA cleared the device, dubbed ARES, or Auris Robotic ...

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