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Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Shots: Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism Processed on IDS’ random-access automation platforms, the expanded portfolio enables…
8 hours ago

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Artera Secures FDA Clearance for AI-Based Breast Cancer Risk Tool

Shots: The US FDA has granted clearance to ArteraAI Breast, a digital pathology-based risk stratification tool for early-stage HR+ /HER2- breast cancer, expanding the company’s oncology AI platform beyond prostate cancer ArteraAI Breast uses multimodal AI combining digitized histopathology images & clinical data to generate an AI-derived risk score predicting distant metastasis risk, helping clinicians…
May 7, 2026

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Cala Reports the US FDA Clearance of Cala kIQ Plus System for Essential Tremor and Parkinson’s Disease

Shots: The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson's disease (PD) The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl. postural & kinetic tremors, using transcutaneous…
April 16, 2026

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Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems

Shots: The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components SMART…
April 13, 2026

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Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence

Shots: The US FDA has granted clearance to Elitone for Men to help restore bladder control after prostate surgery, with US availability expected in Apr 2026 Elitone for Men is a non-invasive, at-home therapy that delivers neuromuscular stimulation to strengthen pelvic floor muscles, improving bladder control, with a simple 20min. daily use enabling consistent treatment…
April 1, 2026

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