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7,990 catalysts · 3,350 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k

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type
  • 8k filing3,350
  • grant1,368
  • device adverse event1,000
  • approval615
  • earnings582
  • device 510k476
device pma
297
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Mar 16, 2026

    50
    ›Mar 19, 2026device 510k151d agoSt. shine Optical Co., Ltd. — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k151d agoWuhan PHOMED Technology Company , Ltd. — CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k151d agoGeistlich Pharma AG — Derma-Gide (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device 510k151d agoLake Region Medical — Enroute 0.014'' Transcarotid Guidewire (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 19, 2026device pma151d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

    Supplement type: Normal 180 Day Track. Product code: PLS. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoMedtronic Sofamor Danek USA, Inc. — INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: NEK. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoMedtronic, Inc. — INFUSE® Bone Graft (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoSenseonics, Incorporated — Eversense® Continuous Glucose Monitoring System (PMA supplement)Senseonics Holdings, Inc.

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

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoABBOTT MEDICAL — Amplatzer™ Amulet™ Left Atrial Appendage Occluder (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoThe Spectranetics Corp. — Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (PMA supplement)

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

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoMedtronic Sofamor Danek USA, Inc. — INFUSE® Bone Graft (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: MPW. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Mar 19, 2026device pma151d agoProverum, Ltd. — ProVee System for BPH (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: MER. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Mar 19, 2026grant151d agoUNIVERSITY OF COLORADO — Splicing-mediated dysregulation of interferon signaling in cancer

    CA grant. $385,333. PI: Edward Bo-yi Chuong

    full page →nih reporter ↗
    ›Mar 19, 2026grant151d agoPURDUE UNIVERSITY — Dissecting the role of tumor suppressing microRNAs in angiosarcoma

    CA grant. $437,654. PI: Jason A. Hanna

    full page →nih reporter ↗
    ›Mar 19, 2026grant151d agoUNIVERSITY OF CALIFORNIA-IRVINE — Harnessing Nutritional Modulation to Enhance Cancer Drug Potency

    CA grant. $403,686. PI: Christopher J. Halbrook

    full page →nih reporter ↗
    ›Mar 19, 2026grant151d agoPORTERCARE ADVENTIST HEALTH SYSTEM — Fibrinolysis Dysfunction Impact on Graft Function in Liver Transplantation

    HL grant. $74,631. PI: Hunter B Moore

    full page →nih reporter ↗
    ›Mar 20, 2026approval150d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

    Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 20, 2026approval150d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 20, 2026approval150d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗
    ›Mar 20, 2026approval150d agoXeomin (incobotulinumtoxinA) — FDA approvalMerz Pharmaceuticals LLC

    Sponsor: MERZ PHARMS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Mar 20, 2026approval150d agoDOXYCYCLINE — FDA approvaldoxycycline ER

    Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

    full page →doxycycline ER →fda approvals ↗
    ›Mar 20, 2026approval150d agoATONCY (ATOMOXETINE HYDROCHLORIDE) — FDA approvalPrasco LLC

    Sponsor: MAP77. Form: SOLUTION. Route: ORAL

    full page →fda approvals ↗
    ›Mar 20, 2026approval150d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Mar 20, 2026approval150d agoMEPRON (ATOVAQUONE) — FDA approvalatovaquone

    Sponsor: GLAXOSMITHKLINE LLC. Form: SUSPENSION. Route: ORAL

    full page →atovaquone →fda approvals ↗
    ›Mar 20, 2026approval150d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2026approval150d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

    Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Mar 20, 2026approval150d agoEPIPEN E Z PEN (EPINEPHRINE) — FDA approvaladrenaline

    Sponsor: VIATRIS. Form: INJECTABLE. Route: INTRAMUSCULAR

    full page →adrenaline →fda approvals ↗
    ›Mar 20, 2026approval150d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2026approval150d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

    Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

    full page →carbamazepine ER →fda approvals ↗
    ›Mar 20, 2026approval150d agoLIDOCAINE HYDROCHLORIDE — FDA approvalLaryng-O-Jet

    Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL

    full page →Laryng-O-Jet →fda approvals ↗
    ›Mar 20, 2026device 510k150d agoIcu Medical, Inc. — ClaveQS™ Bag (510k cleared)ICU MEDICAL INC/DE

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoNexstim Oyj — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoVoco GmbH — Bifix Veneer LC, Bifix Veneer Try-In (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoInstrumentation Laboratory (IL) Co. — HemosIL Factor V Leiden (APC Resistance V) (510k cleared)

    Product code: GGW. Advisory committee: Hematology. Type: Special

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoLiviwell, Inc. — Livi Device (510k cleared)

    Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoDongguan TT Medical, Inc. — Valvuloplasty Balloon Catheter (ValvuloPro) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoNexstim Oyj — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoNox Medical Ehf — Noxturnal Web (510k cleared)

    Product code: OLV. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoGe Medical Systems, LLC — Photonova Spectra, Photonova Spectra Select (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoSiemens Medical Solutions USA, Inc. — SOMATOM X.cite; SOMATOM X.ceed (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

    Product code: MBI. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoOlympus Medical Systems Corporation — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoNordicneurolab AS — nordicAudio (1.0) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoZheJiang J&J Mobility Co., Ltd. — Electric wheelchair (JJW-7002, JJW-7003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoArthrex, Inc. — Arthrex Humeral Nails (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoHangzhou Tappa Medical Technology Co., Ltd. — Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

    Product code: CBI. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoFMD Co., Ltd. — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (510k cleared)

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

    full page →fda device 510k ↗
    ›Mar 20, 2026device 510k150d agoDental Imaging Technologies Corporation — NOMAD Pro 3 (510k cleared)

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

    full page →fda device 510k ↗
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    $SENS6.6900-7.47%
    $MDT91.27+0.76%
    $ICUI182.98-0.07%
    $A148.53-0.51%
    $VTRS16.23+1.18%
    $BMY63.83-1.27%