Tag Archives: FDA

FDA Revises Safety Alert

Updates Guidance and Clears New/Additional Erbe 24-Hour Port Connector  On April 18, 2018, the FDA released a letter to health care providers regarding the use of 24-hour multi-patient use endoscope connectors. In this letter, it was stated that “the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use.” The FDA ...

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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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