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NEWS

Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening

Shots: The US FDA has approved AptimaHPV Assay, an mRNA-based assay for clinician-collected HPV primary screening Approval follows completion of a real-world HPV screening study of 650,000+ women across US, showing the Aptima HPV Assay has clinically comparable sensitivity to an FDA-approved DNA-based HPV test & is effective for detecting CIN2+ & CIN3+ in primary…
February 5, 2026

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ONWARD Medical First Patient in Empower BP Study of ARC-IM System to Treat Blood Pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has enrolled the first patient in its Empower BP study evaluating ARC-IM System for symptomatic blood pressure instability in patients with chronic spinal cord injury The global trial will assess ARC-IM System against a sham in pts with C2–T6 spinal cord injuries & injury severities of AIS A-D across ~20 centers in…
February 4, 2026

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Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…
February 2, 2026

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KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients

Shots: The US FDA has granted 510(k) clearance to FreedomEDGE infusion system to subcutaneously administer Rystiggo (rozanolixizumab-noli) in generalized myasthenia gravis (gMG) patients FreedomEDGE Infusion System enables efficient large-volume SC drug delivery, expanding from home use to clinic-based care to deliver life-changing therapies across various care settings The system supports SC drugs with varying viscosity, flow…
January 30, 2026

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NEXTBIOMEDICAL’s Nexsphere-F Receives Health Canada Approval For Musculoskeletal Pain Embolization

Shots: Health Canada has approved Nexsphere-F for the treatment of musculoskeletal pain embolization Nexsphere-F has launched the pivotal RESORB trial in the US post-IDE approval in 126 knee osteoarthritis pts comparing genicular artery embolization vs corticosteroid injections, with enrollment expected to complete in H1’26 Nexsphere-F uses resorbable microsphere tech to temporarily block abnormal blood flow…
January 30, 2026

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ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Shots: The US FDA has granted 510(k) clearance to ABANZA’s QuadLock Fixation System, a knotless, bidirectional, tension-adjustable device for anterior cruciate ligament (ACL) reconstruction In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated <0.5 mm cyclic displacement representing a >500% reduction in cyclic displacement and >1,000 N pullout strength vs conventional fixation methods QuadLock is…
January 28, 2026

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BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

Shots: The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…
January 27, 2026

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic…
January 23, 2026

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CereVasc Completes Patient Enrolment in ETCHES 1 Study of eShunt System for Communicating Hydrocephalus

Shots: CereVasc completed enrollment in the ETCHES-1 Study evaluating its eShunt System in adults with communicating hydrocephalus resulting from elevated intracranial pressure following post-aneurysmal subarachnoid hemorrhage Study will assess changes in intracranial pressure, device performance & safety, with pts monitored for safety outcomes for up to 24mos. following the procedure eShunt System is designed to…
January 22, 2026

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Trisol Medical Reports US Early Feasibility Study Results on Transcatheter Tricuspid Valve Replacement (TTVR) System

Shots: The US Early Feasibility Study assessed TTVR system in 22 pts with severe to torrential tricuspid regurgitation; enrollment in the trans-jugular cohort is complete, with the study continuing via Trisol’s newly developed trans-femoral access route Safety outcomes showed <5% permanent pacemaker need at 30 days, with considerable reduction in tricuspid regurgitation following implantation At 30 days…
January 22, 2026

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