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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 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…

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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…

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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…

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Abbott

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…

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