Author Archives: Michelle Beaver

2022 Gastroparesis Awareness Month: The Burdens, Concerns, and Quality of Life for Individuals

MOUNT PLEASANT, S.C.—Gastroparesis Awareness Month, established by IFFGD in 2016, takes place every year during the month of August. IFFGD utilizes its platform to support the gastroparesis community by raising awareness to promote education and encourage research. Gastroparesis is a chronic gastrointestinal (GI) disorder affecting approximately 5 million people in the United States and about 38 women and 10 men ...

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FDA Alert: Change in Reprocessing Methods for Certain Karl Storz Urological Endoscopes

The U.S. Food & Drug Administration recently issued a letter to healthcare providers regarding changes to reprocessing methods for certain urological endoscopes manufactured by Karl Storz, due to infection risk. The letter can be found here. An excerpt follows: “As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with ...

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Geneoscopy Starts Clinical Trial for Home Colorectal-Cancer Test

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 ...

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Companies Enter Partnership for Blood Test to Detect Colorectal Cancer and Pre-Cancer

SUNNYVALE, Calif., and ROSWELL, Ga.—CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, recently announced the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing. The financing will be used to accelerate the clinical development of CellMax’s multimodal ...

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FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

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 ...

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