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9,446 catalysts · 3,315 8k filing · 2,029 grant · 1,000 device adverse event · 897 approval · 659 device 510k · 584 earnings

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  • 8k filing3,315
  • grant2,029
  • device adverse event1,000
  • approval897
  • device 510k659
  • earnings584
device pma
503
  • device recall211
  • phase 2 completion172
  • recall167
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 16, 2026

    50
    ›Feb 18, 2026grant178d agoGORDON RESEARCH CONFERENCES — 2026 DNA Damage, Mutation and Cancer Gordon Research Conference and Gordon Re...

    CA grant. $8,000. PI: Shan Zha

    full page →nih reporter ↗
    ›Feb 18, 2026grant178d agoINDIANA UNIVERSITY INDIANAPOLIS — Signaling Mechanisms of Ultra-Stable and Glucose-Regulated Insulin AnalogsShanghai Jiao Tong University

    DK grant. $811,217. PI: Alan D Cherrington

    full page →nih reporter ↗
    ›Feb 19, 2026approval177d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

    Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION

    full page →elranatamab →fda approvals ↗
    ›Feb 19, 2026approval177d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

    Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 19, 2026approval177d agoBRIVARACETAM — FDA approvalBRIVARACETAM

    Sponsor: MSN. Form: SOLUTION. Route: ORAL

    full page →BRIVARACETAM →fda approvals ↗
    ›Feb 19, 2026approval177d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

    Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

    full page →mogamulizumab →fda approvals ↗
    ›Feb 19, 2026approval177d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 19, 2026approval177d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 19, 2026approval177d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

    Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Feb 19, 2026approval177d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Feb 19, 2026approval177d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Feb 19, 2026approval177d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →venetoclax →fda approvals ↗
    ›Feb 19, 2026device 510k177d agoMiRus, LLC — ATLAS™ Expandable Osteotomy Wedge System (510k cleared)

    Product code: PLF. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoErchonia Corporation — Erchonia DPN Laser (Model# EVRL) (510k cleared)

    Product code: NHN. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoAlphatec Spine, Inc. — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (510k cleared)

    Product code: OLO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoGM Dos Reis Industria e Comercio Ltda. — Meniscus Versaflex (510k cleared)

    Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoEsthetic Medical, Inc. — SkinStylus SteriLock MicroSystem (MP1209SL) (510k cleared)

    Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoAS Software, LLC — AS Software Version Asera (510k cleared)

    Product code: LLZ. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoSilony Medical GmbH — VERTICALE GPS Instruments (510k cleared)

    Product code: OLO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoElekta Solutions AB — Monaco RTP System (6.3) (510k cleared)

    Product code: MUJ. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoEfofex, Inc. — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (510k cleared)

    Product code: FXX. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoBeckman Coulter, Inc. — Access anti-HBc Total (510k cleared)

    Product code: SEI. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoGuilin Refine Medical Instrument Co., Ltd. — Portable Dental X-ray Device (GT-1) (510k cleared)

    Product code: EHD. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoLacerta Life Sciences — LacertaMatrix (510k cleared)

    Product code: KGN. Advisory committee: Unknown. Type: Special

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoStryker Leibinger GmbH & Co KG — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (510k cleared)

    Product code: OLO. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoAcclarent, Inc. — Acclarent AERA Eustachian Tube Balloon Dilation System (510k cleared)

    Product code: PNZ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoCMT Health PTE., Ltd. — Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (510k cleared)

    Product code: QNQ. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus (510k cleared)Medical Care Technologies Inc.

    Product code: MUJ. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoMedtronic, Inc. — Retrograde Coronary Sinus Perfusion Cannulae (510k cleared)Medtronic plc

    Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 19, 2026device 510k177d agoCenterPoint Systems, LLC — AuST CSP Introducer (510k cleared)

    Product code: DYB. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Feb 19, 2026device pma177d agoABBOTT MEDICAL — Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular) (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoAlcon Laboratories, LLC — Clareon TruPlus Aspheric Hydrophobic Acrylic Intraocular Lens (IOL); Clareon TruPlus Toric Aspheric Hydrophobic Acrylic (PMA supplement)Alcon Laboratories Inc

    Supplement type: Real-Time Process. Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoABBOTT MEDICAL — Quartet; QuickFlex Micro (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoVeryan Medical, Ltd. — BioMimics 3D® Vascular Stent System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoABBOTT MEDICAL — Durata, Optisure (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoMedtronic Neuromodulation — Master Restore, Itrel, Synerg, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (PMA supplement)

    Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoABBOTT MEDICAL — Tendril STS; OptiSense; UltiPace (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoBiomet Microfixation, Inc. — Total Temporomandibular Joint Replacement System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LZD. Advisory committee: DE. Decision: OK30

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoBolton Medical, Inc. — RelayPro Thoracic Stent-Graft System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoABBOTT MEDICAL — IsoFlex (PMA supplement)

    Supplement type: 135 Review Track For 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device pma177d agoEdwards Lifesciences, LLC — SAPIEN M3 Transcatheter Mitral Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

    Supplement type: Normal 180 Day Track No User Fee. Product code: NPU. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 19, 2026device recall177d agoAMO Puerto Rico Manufacturing, Inc. device recall (Cls II)

    Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No — Reason: Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 19, 2026grant177d agoSTANFORD UNIVERSITY — Salmonella persistence in Mesenteric Lymph NodesStanford University

    AI grant. $771,210. PI: Denise M Monack

    full page →nih reporter ↗
    ›Feb 19, 2026grant177d agoGEORGIA STATE UNIVERSITY — Nanobodies as effective therapeutic agents against H5N1 influenza virus

    AI grant. $434,938. PI: Lanying Du

    full page →nih reporter ↗
    ›Feb 19, 2026grant177d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — Role of nuclear paraspeckles in regulating HSV-1 infection in neurons

    AI grant. $250,682. PI: Leonardo D'Aiuto

    full page →nih reporter ↗
    ›Feb 19, 2026grant177d agoTHOMAS JEFFERSON UNIVERSITY — Trained Immunity Induced by mRNA-LNP

    AI grant. $813,921. PI: Botond Z Igyarto

    full page →nih reporter ↗
    ›Feb 19, 2026grant177d agoNATIONAL JEWISH HEALTH — Prenatal programming of immune cells for tissue repair and remodeling in asthmaTissue Repair Ltd

    AI grant. $776,394. PI: Magdalena Maria Gorska

    full page →nih reporter ↗
    ›Feb 19, 2026grant177d agoUNIVERSITY OF ROCHESTER — LUNG CELLULAR SENESCENCE AND MOLECULAR CLOCK REV-ERBalpha BY ENVIRONMENTAL TO...University of Rochester

    ES grant. $906,000. PI: IRFAN RAHMAN

    full page →nih reporter ↗
    ›Feb 19, 2026grant177d agoNORTHWESTERN UNIVERSITY AT CHICAGO — Pseudomonas aeruginosa Carriage in the Gastrointestinal TractNorthwestern University

    AI grant. $431,784. PI: ALAN R HAUSER

    full page →nih reporter ↗
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    $MDCE0.00020.00%
    $ABBV250.05-0.31%
    $AZN156.28-0.61%
    $EW91.33-2.47%
    $PYPD4.7500-0.63%
    $AZN156.28-0.61%
    $PFE26.61-0.73%
    $MDT90.58-0.20%