FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions

On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s […]

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Denali Therapeutics, Alucent Biomedical, Present to Utah Life Sciences Innovation Caucus

Utah legislators on Wednesday, June 14, held a meeting of the Utah Life Sciences Innovation Caucus (ULSIC) at the state capitol. BioUtah President and CEO, Kelvyn Cullimore, kicked off the meeting and introduced representatives from Denali Therapeutics and Alucent Biomedical who presented before the ULSIC. Cindy Dunkle, chief people officer for Denali, described the company’s […]

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Merit Medical Announces Acquisition of Dialysis Catheter Portfolio and the BioSentry® Biopsy Tract Sealant System from AngioDynamics, Inc. and Acquisition of the Surfacer® Inside-Out® Access Catheter System from Bluegrass Vascular Technologies, Inc.

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Acquisitions broaden Merit’s therapeutic platform with diverse dialysis product solutions and expand its access catheter offering Acquisitions projected to add approximately $30 million of revenue, on an annualized basis, in key strategic markets that leverage existing commercial footprint Merit re-affirms full-year 2023 financial guidance on stand-alone basis and updates full-year 2023 financial guidance to include […]

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KOLOSIS BIO AND MTF BIOLOGICS FORGE STRATEGIC PARTNERSHIP TO ENTER SURGICAL INCISION MARKET

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SALT LAKE CITY, Utah – May 30, 2023 (OrthoSpineNews)- Kolosis BIO (Kolosis), a leading provider of biologics solutions, and MTF Biologics, a global tissue processor and nonprofit organization, are excited to announce their partnership in the surgical incision market. This strategic collaboration represents Kolosis BIO’s expansion into a new area of healthcare, while providing MTF […]

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