Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

Shots: Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial Assays Panther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow…

ByRidhi RastogiOctober 3, 2025

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AVITA Medical Secures European CE Mark Approval for Recell Go to Advance Burn and Wound Healing

Shots: AVITA Medical has received European MDR CE Mark approval for Recell Go to promote healing in burns & traumatic or surgical wounds; commercialization to begin in select EU states, incl. Germany, Italy, & the UK Recell Go is a point-of-care device that allows clinicians to create a suspension of a patient’s own skin cells from…

ByRidhi RastogiSeptember 15, 2025

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QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections

Shots: QIAGEN has obtained European CE-IVDR certification for its QIAstat-Dx Meningitis/Encephalitis (ME) Panel to diagnose CNS infections, securing CE-IVDR approval for its entire QIAstat-Dx syndromic testing systems & panels The QIAstat-Dx ME Panel offers CNS infection coverage with 16 clinically relevant targets, incl. cytomegalovirus to meet current clinical needs & exclusive Streptococcus pyogenes detection to…

ByRidhi RastogiSeptember 11, 2025

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Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

Shots: Varian has reported the European CE Mark approval of Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritis Additionally, a Varian-sponsored GENESIS II trial, assessing GAE vs sham treatment for knee osteoarthritis, has completed patient enrollment in the UK GAE aims to reduce knee pain by advancing a small catheter into the…

ByRidhi RastogiSeptember 9, 2025

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ONWARD Medical’s ARC-EX System Receives the European CE Mark Approval for Spinal Cord Stimulation

Shots: ONWARD Medical has received MDR CE Mark approval for its ARC-EX system to treat people with spinal cord injury (SCI); first EU commercial sales are expected by Q4’25 Approval was backed by extensive clinical data, incl. Up-LIFT trial published in Nature Medicine, showing 90% pts improved strength or function, 87% reported better QoL, &…

ByRidhi RastogiSeptember 8, 2025

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GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Shots: GE HealthCare has launched Vivid Pioneer, a cardiovascular ultrasound for 2D, 4D, & color flow imaging, following the European CE Mark approval & the US FDA’s 510(k) clearance Vivid Pioneer is powered by cSound architecture & XDclear tech to provide superior resolution, color sensitivity, & 4D imaging, allowing structure visualization & cardiac function assessment…

ByRidhi RastogiSeptember 2, 2025

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Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Shots: Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty in pts (n >260) with PAD BTK, which showed sustained efficacy & ability to open vessels…

ByRidhi RastogiAugust 27, 2025

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Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Shots: Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of…

ByRidhi RastogiJuly 23, 2025

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Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Shots: Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

ByRidhi RastogiJuly 22, 2025

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MatOrtho Receives the European CE Mark Approval for ReCerf Hip Resurfacing Arthroplasty

Shots: MatOrtho has reported the European CE Mark approval of ReCerf for hip resurfacing arthroplasty, allowing wider availability in UK, EU & markets accepting CE mark approval ReCerf was previously approved by Australia’s TGA in Nov 2024 & was used in over 1,600 pts since 2018, with highly positive patient-reported outcomes & a low 6yr. revision…

ByRidhi RastogiJuly 4, 2025

Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

AVITA Medical Secures European CE Mark Approval for Recell Go to Advance Burn and Wound Healing

QIAGEN Secures CE-IVDR Certification for QIAstat-Dx Meningitis/Encephalitis Panel to Detect CNS Infections

Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

ONWARD Medical’s ARC-EX System Receives the European CE Mark Approval for Spinal Cord Stimulation

GE HealthCare Launches Vivid Pioneer for Enhanced Cardiac Imaging

Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee

Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

MatOrtho Receives the European CE Mark Approval for ReCerf Hip Resurfacing Arthroplasty

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