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9,516 catalysts · 3,345 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 584 earnings

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  • 8k filing3,345
  • grant2,032
  • device adverse event1,000
  • approval910
  • device 510k674
  • earnings584
device pma
508
  • device recall215
  • phase 2 completion172
  • recall167
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 23, 2026

    50
    ›Feb 26, 2026device 510k170d agoDePuy Mitek, Inc. — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k170d agoCopioumed International, Inc. — Copioumed AAMI 3 Surgical Gown (510k cleared)COMPX INTERNATIONAL INC

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k170d agoOwl Dental Lab, Inc. — Owl Night Guard (510k cleared)

    Product code: OBR. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k170d agoDisior, Ltd. — ENOS Software Guided External Fixation System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k170d agoSpeciality Fibres and Materials Limited — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm (510k cleared)

    Product code: QSY. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k170d agoEnbio Group AG — Enbio PRO (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 26, 2026device pma170d agoMedtronic, Inc. — CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Delivery Catheter System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoCardiovascular Systems, Inc. — Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoScibase AB — Nevisense (PMA supplement)

    Supplement type: Real-Time Process. Product code: ONV. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoIntera Oncology — lntera 3000 Hepatic Artery Infusion Pump (PMA supplement)

    Supplement type: Real-Time Process. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoAlcon Laboratories, Inc. — Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear (PMA supplement)Alcon Laboratories Inc

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoMicroTransponder, Inc. — Vivistim® Paired VNS System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QPY. Advisory committee: PM. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoETHICON, Inc. — ETHIZIA Hemostatic Patch (PMA supplement)

    Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoKARL STORZ Endoscopy-America, Inc. — Photodynamic Diagnostic D-Light C (PDD) System (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 26, 2026device pma170d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA)

    Product code: MJO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026grant170d agoBETH ISRAEL DEACONESS MEDICAL CENTER — THWART-TB : Testing Health Workers At Risk to advance our understanding of TB...

    AI grant. $111,645. PI: Ruvandhi Nathavitharana

    full page →nih reporter ↗
    ›Feb 26, 2026grant170d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Uncovering Morphogenetic Modularity with Data Science

    GM grant. $400,881. PI: Tomer Stern

    full page →nih reporter ↗
    ›Feb 26, 2026grant170d agoUNIVERSITY OF CALIFORNIA AT DAVIS — Multi-glycomic characterization of cell membrane and the role of glycans in p...

    GM grant. $402,051. PI: CARLITO B LEBRILLA

    full page →nih reporter ↗
    ›Feb 27, 2026approval169d agoPREZCOBIX (DARUNAVIR AND COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

    Sponsor: JANSSEN PRODS. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Feb 27, 2026approval169d agoDILTIAZEM HYDROCHLORIDE — FDA approvalDILTIAZEM HYDROCHLORIDE

    Sponsor: MACLEODS PHARMS LTD. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →DILTIAZEM HYDROCHLORIDE →fda approvals ↗
    ›Feb 27, 2026approval169d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

    Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 27, 2026approval169d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

    Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

    full page →lurbinectedin →fda approvals ↗
    ›Feb 27, 2026approval169d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

    Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 27, 2026approval169d agoCALCITRIOL — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: HUMANWELL PURACAP. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 27, 2026approval169d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

    Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 27, 2026approval169d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

    Sponsor: ALMATICA. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →duloxetine hydrochloride DR →fda approvals ↗
    ›Feb 27, 2026approval169d agoIZERVAY (AVACINCAPTAD PEGOL SODIUM) — FDA approvalavacincaptad pegol sodium

    Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL

    full page →avacincaptad pegol sodium →fda approvals ↗
    ›Feb 27, 2026approval169d agoREBLOZYL (LUSPATERCEPT-AAMT) — FDA approvalluspatercept

    Sponsor: CELGENE CORP. Form: POWDER. Route: SUBCUTANEOUS

    full page →luspatercept →fda approvals ↗
    ›Feb 27, 2026approval169d agoYUVIWEL (NAVEPEGRITIDE) — FDA approvalnavepegritide

    Sponsor: ASCENDIS. Form: POWDER. Route: SUBCUTANEOUS

    full page →navepegritide →fda approvals ↗
    ›Feb 27, 2026approval169d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

    full page →tedizolid phosphate →fda approvals ↗
    ›Feb 27, 2026approval169d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →somatriptan albumin bound LA →fda approvals ↗
    ›Feb 27, 2026approval169d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →somatriptan albumin bound LA →fda approvals ↗
    ›Feb 27, 2026approval169d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →somatriptan albumin bound LA →fda approvals ↗
    ›Feb 27, 2026approval169d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

    full page →tedizolid phosphate →fda approvals ↗
    ›Feb 27, 2026approval169d agoDESMOPRESSIN ACETATE — FDA approvalFerring Pharmaceuticals Inc

    Sponsor: CAPLIN. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 27, 2026device 510k169d agoHankil Tech Medical Co., Ltd. — HKT Anatomical Locking Trauma System (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoSiemens Healthcare Diagnostics, Inc. — Atellica CH Diazo Total Bilirubin (D_TBil) (510k cleared)

    Product code: CIG. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoBeijing HuaCheng Taike Technology Co., Ltd. — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoLigence Uab — Ligence Heart (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoMediclus Co., Ltd. — One-Stop (510k cleared)

    Product code: MVL. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoAvita Corporation — AViTA Pulse Oximeter (SP61) (510k cleared)Teva Pharmaceuticals USA Inc

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoElevate Oral Care — Allday Moisturizing Rinse (510k cleared)

    Product code: LFD. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoBeijing HuaCheng Taike Technology Co., Ltd. — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoVigor Medical Technologies , Ltd. — C-Lant Port (510k cleared)KESTRA MEDICAL TECHNOLOGIES, LTD.

    Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoRiverpoint Medical, LLC — LigaMend (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoEpineuron Technologies, Inc. — Evala Nerve Stimulator (EPNR002) (510k cleared)Exyn Technologies, Inc.

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device 510k169d agoAtraverse Medical — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 27, 2026device pma169d agoIntegra LifeSciences Corporation — DuraSeal Exact Spine Sealant System (PMA supplement)INTEGRA LIFESCIENCES HOLDINGS CORP

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

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic Neuromodulation — Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

    full page →fda device pma ↗
    ›Feb 27, 2026device pma169d agoMedtronic, Inc. — Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
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    $CIX23.11+2.78%
    $MDT91.62+1.15%
    $GILD138.36+0.16%
    $NVO45.89-1.78%
    $NVO45.89-1.78%
    $KMTS20.35+8.13%
    $JAZZ244.96-0.36%
    $GILD138.36+0.16%
    $IART18.240.00%
    $BMRN67.59-1.37%
    $NVO45.89-1.78%
    $EXYN4.3000-14.00%
    $MDT91.62+1.15%