Calendar

Week of Dec 15, 2025

Dec 19, 2025device recall253d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS — Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. — Status: Ongoing

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Dec 19, 2025device recall253d agoCanon Medical System, USA, INC. device recall (Cls II)

Alphenix INFX-8000H, interventional fluoroscopic x-ray system — Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed — Status: Ongoing

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Dec 19, 2025device recall253d agoBoston Scientific Corporation device recall (Cls I)BOSTON SCIENTIFIC CORP

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530; — Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. — Status: Ongoing

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Dec 19, 2025device recall253d agoCanon Medical System, USA, INC. device recall (Cls II)

Alphenix INFX-8000V, interventional fluoroscopic x-ray system — Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed — Status: Ongoing

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Dec 19, 2025device recall253d agoBoston Scientific Corporation device recall (Cls I)BOSTON SCIENTIFIC CORP

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690; — Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site. — Status: Ongoing

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Dec 19, 2025device recall253d agoAltruan GmbH device recall (Cls II)

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. — Reason: Product not cleared by the FDA. — Status: Ongoing

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Dec 19, 2025device recall253d agoTyber Medical device recall (Cls II)

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm — Reason: The supplier manufactured anatomical left plates with an incorrect thread orientation. — Status: Ongoing

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Dec 19, 2025device recall253d agoCanon Medical System, USA, INC. device recall (Cls II)

Alphenix INFX-8000C, interventional fluoroscopic x-ray system — Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed — Status: Ongoing

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Dec 19, 2025device recall253d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS — Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. — Status: Ongoing

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Dec 19, 2025device recall253d agoAltruan GmbH device recall (Cls II)

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. — Reason: Product not cleared by the FDA. — Status: Ongoing

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Dec 19, 2025grant253d agoNEW YORK UNIVERSITY SCHOOL OF MEDICINE — Plasticity and social neuromodulation of developing auditory cortical circuitsNew York University

DC grant. $134,109. PI: Megan Anne Kirchgessner

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Dec 19, 2025grant253d agoUNIVERSITY OF MINNESOTA — MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA)University of Minnesota

HL grant. $794,063. PI: JAMES S PANKOW

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Dec 19, 2025grant253d agoUNIVERSITY OF CONNECTICUT SCH OF MED/DNT — Examining the role of locus coeruleus glucagon-like peptide-1 receptors infee...Xeris Biopharma Holdings, Inc.

DK grant. $150,930. PI: Samantha Fortin

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Dec 19, 2025grant253d agoUNIVERSITY OF WASHINGTON — MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA) - TASK AREA AUniversity of Washington

HL grant. $3,202,749. PI: Robyn Leagh McClelland

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Dec 19, 2025grant253d agoUNIVERSITY OF CALIFORNIA BERKELEY — Leveraging Adaptive Evolution and High-Throughput Techniques to Dissect the L...

OD grant. $802,500. PI: Margaux Pinney

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Dec 19, 2025grant253d agoNORTHWESTERN UNIVERSITY AT CHICAGO — MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA) - FIELD CENTERNorthwestern University

HL grant. $829,413. PI: NORRINA Bai ALLEN

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Dec 19, 2025grant253d agoJOHNS HOPKINS UNIVERSITY — MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA)Johns Hopkins University

HL grant. $697,200. PI: WENDY S POST

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Dec 19, 2025grant253d agoUNIVERSITY OF CALIFORNIA LOS ANGELES — MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA) - FIELD CENTER (FC), TASK AREA AUniversity of California Los Angeles

HL grant. $674,872. PI: KAROL E WATSON

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Dec 19, 2025grant253d agoWAKE FOREST UNIVERSITY HEALTH SCIENCES — MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS (MESA) - FIELD CENTER, TASK AREA AWake Forest University

HL grant. $505,956. PI: Alain Gerald Bertoni

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Dec 19, 2025grant253d agoGEORGE WASHINGTON UNIVERSITY — AIDS and Cancer Specimen Resource (ACSR)

CA grant. $897,500. PI: Jeffrey Michael Bethony

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Week of Dec 22, 2025

Dec 22, 2025approval250d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

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Dec 22, 2025approval

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