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Roche
NEWS

Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…
May 12, 2026

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Bayer
NEWS

Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 evuzamitide to Diagnose Cardiac Amyloidosis

Shots: Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170  adults with suspected cardiac amyloidosis Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…
May 7, 2026

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NEWS

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Shots: Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026 The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…
April 23, 2026

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NEWS

Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System

Shots: The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications The system enables simultaneous…
April 17, 2026

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NEWS

Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases

Shots: Natera has reported the commercial launch of Zenith genomics, a next-generation whole genome sequencing (WGS) assay designed to enhance the detection of rare diseases in the US The platform combines whole genome sequencing with long-read sequencing confirmation to detect genomic features such as tandem repeat expansions, supporting diagnosis of rare & ultra-rare conditions, &…
March 13, 2026

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NEWS

C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea

Shots: C2N Diagnostics has entered into an agreement with BeauBrain Healthcare to offer PrecivityAD2 blood test for use in pts (≥50yrs.) with signs or symptoms of mild cognitive impairment or dementia in South Korea Study in The JAMA showed PrecivityAD2 improved diagnostic accuracy of Alzheimer’s disease vs SoC, while research in npj Dementia showed that the test demonstrated 91%…
March 12, 2026

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Roche
NEWS

Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections

Shots: Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help…
December 2, 2025

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NEWS

GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

Shots: The US FDA has received 510(k) submissions for SIGNA MRI technology, unveiled at RSNA 2025, to enhance diagnostics with advanced imaging innovations SIGNA Bolt focuses on high-performance 3.0T imaging with ultra-high gradients, AI-enabled workflows, & research-grade flexibility, while SIGNA Sprint with Freelium emphasizes accessibility through a helium-minimal (<1% helium usage) ventless 1.5T system designed for installation…
December 1, 2025

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NEWS

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC Oncomine Dx Target Test, first…
November 21, 2025

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NEWS

Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis

Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…
November 13, 2025

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