Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Shots: The US FDA has approved AptimaHPV Assay, an mRNA-based assay for clinician-collected HPV primary screening Approval follows completion of a real-world HPV screening study of 650,000+ women across US, showing the Aptima HPV Assay has clinically comparable sensitivity to an FDA-approved DNA-based HPV test & is effective for detecting CIN2+ & CIN3+ in primary…

ByRidhi RastogiFebruary 5, 2026

NEWS

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…

ByRidhi RastogiFebruary 4, 2026

NEWS

BD’s EnCor EnCompass System Secures the US FDA 510(k) Clearance for Breast Biopsy

Shots: The US FDA has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease The EnCor EnCompass Biopsy System streamlines breast biopsy procedures by allowing clinicians to use a single integrated system across multiple imaging platforms,…

ByRidhi RastogiJanuary 16, 2026

NEWS

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…

ByRidhi RastogiDecember 1, 2025

NEWS

Philips Unveils Verida to Improve Diagnostic Imaging

Shots: Royal Philips has launched Verida, a detector-based spectral CT fully powered by AI, at RSNA 2025, with availability in select markets beginning in 2026 Verida integrates AI across the entire imaging chain to deliver high-quality spectral & high-definition images with minimal noise, while enabling significant dose reductions & reducing energy use by ~45% Verida reconstructs…

ByRidhi RastogiDecember 1, 2025

NEWS

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Shots: The US FDA has granted De Novo authorization to Visby Medical Women's Sexual Health Test for OTC use Clinical studies with 2,000+ users showed that the test offers comparable accuracy to laboratory-based PCR machines, whereas its companion app guides users through testing, interpretation of results, & provides further care options Visby Medical Women's Sexual…

ByRidhi RastogiMarch 31, 2025

NEWS

Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Shots: Sutter Health and GE HealthCare signed a 7yrs. strategic collaboration agreement (Care Alliance), to enhance access to imaging services for patient and clinician experiences in California. This will enable faster appointments, quicker imaging results, and more consistent care Sutter Health's key initiatives include a fast technology program to deploy advanced AI imaging tools…

BySenior EditorJanuary 17, 2025

Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

BD’s EnCor EnCompass System Secures the US FDA 510(k) Clearance for Breast Biopsy

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Philips Unveils Verida to Improve Diagnostic Imaging

Visby Medical Reports the US FDA’s De Novo Authorization of its Women’s Sexual Health Test for Over-the-Counter Use

Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Contact US

FOLLOW US