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 infectionsThe 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…

ByRidhi RastogiDecember 2, 2025

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Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

Shots:Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG)EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure timesThe company has planned to launch EndoZip in select EU centers &…

ByRidhi RastogiNovember 7, 2025

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UroViu Receives European CE Certification for its Cystoscope and Hysteroscope Portfolio

Shots:UroViu has received European CE Mark approval for its cystoscope & hysteroscope portfolio, incl. the reusable UV5000w Wi-Fi Handle & disposable Hystero-V, Uro-V, & Uro-GHD endoscopesUroViu’s portfolio has shown strong clinical value & efficiency in cystoscopy procedures, incl. diagnosis, cancer surveillance & minor therapeutic interventions, as highlighted in data presented at EAU &…

ByRidhi RastogiNovember 7, 2025

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Roche Receives the European CE Mark for its Elecsys Dengue Ag Test for Dengue Virus Detection

Shots:Roche has reported CE Mark approval of its Elecsys Dengue Ag test to aid in the diagnosis of an acute dengue virus infectionThe Elecsys Dengue Ag is an in-vitro immunoassay for qualitative detection of the dengue virus NS1 antigen in human serum & plasma, designed for use on Roche’s cobas e 801 & cobas…

ByRidhi RastogiOctober 29, 2025

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Alife Health Receives CE Mark for Embryo Predict AI Embryo Selection Tool

Shots:Alife Health has reported the European CE mark approval of Embryo Predict, an AI-based embryo selection software for in vitro fertilization (IVF)Alife will initiate the rollout of Embryo Predict across selected IVF clinics in the EU, building on the company’s progress in the US with the Clinical Decision Support platform & collaborations with…

ByRidhi RastogiOctober 24, 2025

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Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Shots:Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…

ByRidhi RastogiOctober 15, 2025

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Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

Shots:Vektor Medical has received the European CE Mark approval for vMap System for non-invasive arrhythmia mappingvMap System converts 12-lead ECG data into 3D arrhythmia source maps within a minute to help identify arrhythmia drivers & guide treatment for atrial fibrillation & ventricular tachycardiaThe system also integrates with lab workflows to deliver rapid, non-invasive,…

ByRidhi RastogiOctober 8, 2025

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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 AssaysPanther 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 UKRecell 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 & panelsThe 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

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

Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty

UroViu Receives European CE Certification for its Cystoscope and Hysteroscope Portfolio

Roche Receives the European CE Mark for its Elecsys Dengue Ag Test for Dengue Virus Detection

Alife Health Receives CE Mark for Embryo Predict AI Embryo Selection Tool

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care

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

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