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Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology

November 18, 2025

PLANO, Texas, Nov. 18, 2025 /PRNewswire/ — Vesalio, a leader in innovative thrombectomy solutions, today announced two new FDA 510(k) clearances for its aspiration devices, designed for peripheral and neurovascular applications. These clearances mark a key milestone in Vesalio’s evolution toward providing a complete suite of thrombectomy products across multiple vascular territories.

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Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

November 18, 2025

CAMBRIDGE, Mass., Nov. 18, 2025 /PRNewswire/ — Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s novel assay for the rapid detection of infection in patients with suspected, or at risk of, complicated urinary tract infections (UTIs).

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Piccolo Medical® Receives FDA Clearance to Expand ECGuide™ Technology Use to Pediatric and Neonatal Patients

November 18, 2025

SAN FRANCISCO, Nov. 18, 2025 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications for Use for its PM2™ System and ECGuide™ Connector. This clearance extends the technology’s use as an alternative to chest x-ray for a variety of central venous access devices in pediatric and neonatal patient populations.

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BD Onclarity™ HPV Assay for BD COR™ and BD Viper™ LT Systems Receive WHO Prequalification

November 17, 2025

FRANKLIN LAKES, N.J., Nov. 17, 2025 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the Conformité Européenne (CE) Marked BD Onclarity™ HPV Assay for the BD COR™ System and the BD Viper™ LT System have been accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostic products, further expanding access to high-quality cervical cancer screening tools in low- and middle-income countries.

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Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology

November 14, 2025

WARSAW, Ind., Nov. 14, 2025 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ROSA® Knee with OptimiZe™, an enhanced version of its ROSA® Knee System that offers a more customized experience for surgeons to help deliver accurate and reproducible outcomes1 in robotic-assisted total knee replacement surgery.

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