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Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments

HENDERSON, Nev., March 31, 2026 /PRNewswire/ — Restore Robotics today announced it has received additional 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the remanufacturing of two more da Vinci Xi® robotic surgical instruments. This milestone expands Restore Robotics’ growing portfolio of cleared instruments and further strengthens its position as a leader in robotic instrument remanufacturing.

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New FDA-Cleared At-Home Treatment Helps Men Regain Bladder Control After Prostate Surgery

NEWTOWN, Conn., March 31, 2026 /PRNewswire/ — Elidah today announced FDA clearance of Elitone for Men, a non-invasive, at-home treatment designed to help men regain bladder control after prostate surgery, addressing a significant and often overlooked men’s health condition. Urinary incontinence, or bladder leakage, is one of the most common and disruptive complications following prostate procedures, yet men have had few options to actively support recovery at home.

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Breaking the PCR-Only Barrier: Dual 510(k) Clearance and CLIA-Waiver Establish FINDER as the First Molecular Point-of-Care Platform with Multifunctional Capabilities

DURHAM, N.C., March 31, 2026 /PRNewswire/ — Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the FINDER® Flu A&B/SARS-CoV-2 Test, an ultra-rapid RT-PCR assay on the FINDER platform. This establishes FINDER as the first molecular point-of-care platform with multifunctional capabilities. The compact, automated system delivers PCR-quality results during the patient visit, with positives as early as 15 minutes and negatives in about 20 minutes, giving urgent care centers, emergency departments, clinics, and other decentralized settings the speed, ease of use, and reliability needed for better diagnostic decisions.

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