Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…

ByRidhi RastogiAugust 24, 2026

NEWS

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Shots: Bracco Imaging has received the US FDA 510(k) clearance & Health Canada authorization for VueJect, its dedicated ultrasound contrast delivery system designed specifically for cardiology imaging VueJect is designed to improve workflow efficiency, reduce operator variability & enable continuous administration of ultrasound contrast agents for more consistent enhancement during cardiac imaging VueJect will initially…

ByRidhi RastogiAugust 12, 2026

NEWS

iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

Shots: The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…

ByRidhi RastogiJuly 9, 2026

NEWS

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

Shots: The US FDA has granted clearance to Flu and COVID-19 Test, an at-home PCR test capable of detecting multiple respiratory viruses, expanding its portfolio of over-the-counter molecular diagnostics The test delivers PCR-quality results in 30min. & detects COVID-19 and influenza A/B at home, enabling earlier diagnosis & timely treatment decisions, incl. access to antiviral…

ByRidhi RastogiJuly 3, 2026

EVENTS

HLTH Europe 2026: Key Highlights & Industry Insights

Shots • HLTH Europe 2026 brought together over 5,000 healthcare leaders, investors, policymakers, payers, providers, pharmaceutical executives, and digital health innovators in Amsterdam to explore the future of healthcare innovation. • Healthcare has a paradox: brilliant point solutions are failing not because they don't work, but because they can't talk to each other. A patient…

ByAditya SinghJune 22, 2026

EVENTS

London Biotechnology Show 2026 | 18-19 November | Excel London

Get ready to connect with the innovators, investors, and industry leaders shaping the future of biotechnology at the London Biotechnology Show 2026. Taking place alongside London Life Sciences Week, the event is set to become one of the UK’s most influential gatherings for the global biotech and life sciences ecosystem. Bringing together 4,000+ attendees and…

BySaurabh ChaubeyJune 12, 2026

NEWS

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…

ByRidhi RastogiMay 27, 2026

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…

ByRidhi RastogiMay 12, 2026

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…

ByRidhi RastogiMay 7, 2026

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…

ByRidhi RastogiApril 23, 2026

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

Visby Medical Secures FDA Clearance for At-Home Flu & COVID-19 PCR Test

HLTH Europe 2026: Key Highlights & Industry Insights

London Biotechnology Show 2026 | 18-19 November | Excel London

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

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

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

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

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