ST. LOUIS, Missouri—Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced the enrollment of its first patients in the CRC-PREVENT pivotal trial. The clinical study seeks to evaluate the safety and efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a ...

BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. The product is used as an antiseptic for the preparation of the patient’s skin prior to surgery ...

This week the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes—devices used to view and access the urinary tract. Reprocessing these types of medical devices involves both cleaning and high-level disinfection or sterilization so the devices ...

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 ...

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 ...