Blog

- CERTIFICATIONS

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.

Read More »

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.

Read More »

Haemonetics Receives FDA Approval for Expanded Labeling of the VASCADE MVP® XL Venous Vascular Closure System

BOSTON, March 30, 2026 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) approval to expand the labeling for the VASCADE MVP® XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. With this label expansion, the VASCADE MVP XL system is approved for larger sheaths used in market-leading technologies for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) to treat atrial fibrillation.

Read More »