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21,798 catalysts · 4,728 grant · 4,017 device 510k · 3,316 8k filing · 3,109 approval · 2,000 device pma · 2,000 device recall

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 32 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • grant4,728
  • device 510k4,017
  • 8k filing3,316
  • approval3,109
  • device pma2,000
  • device recall2,000
device adverse event
1,000
  • recall963
  • earnings584
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Jan 13, 2025

    50
    ›Jan 16, 2025approval576d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Jan 16, 2025approval576d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

    Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

    full page →CALQUENCE →fda approvals ↗
    ›Jan 16, 2025device 510k576d agoInmedix, Inc. — CloudHRV™ System (100-01-001) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoYa-Man, Ltd. — Medi Lift Mask (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoCala Health, Inc. — Cala kIQ (510k cleared)CARDINAL HEALTH INC

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoWondfo USA Co, Ltd. — WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoVieworks Co., Ltd. — VIVIX-M (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoDeka Research and Development Corp. — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoPearl, Inc. — Second Opinion CC (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoStryker Instruments — System 9 Sterile Battery Container (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoNu Eyne Co., Ltd. — ADDNOX (BPSPM1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoBiofire Diagnostics, LLC — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (510k cleared)

    Product code: PCH. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoAxis-Shield Diagnostics, Ltd. — Alere NT-proBNP for Alinity i Reagent Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoRoche Molecular Systems, Inc. — cobas® liat CT/NG/MG nucleic acid test (510k cleared)

    Product code: QEP. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoPepper Interactive, Inc. — Pepper EMS Training System (510k cleared)PELOTON INTERACTIVE, INC.

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoPearl Digital, Inc. — Pearl Clear Aligner (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 16, 2025device 510k576d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025approval575d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

    full page →fda approvals ↗
    ›Jan 17, 2025approval575d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

    Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

    full page →taliglucerase alfa →fda approvals ↗
    ›Jan 17, 2025approval575d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

    Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

    full page →fda approvals ↗
    ›Jan 17, 2025device 510k575d agoMED-EL Elektromedizinische Geräte GmbH — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoAirgas Therapeutics, LLC — ULSPIRA TS™ Nitric Oxide Therapy System (510k cleared)AUG Therapeutics LLC

    Product code: MRN. Advisory committee: Anesthesiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) — The ETHICON™ Total Energy System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoSHENZHEN SUPERLINE TECHNOLOGY CO., LTD. — Electronic Apex Locator (Alpha Apex I) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoVarian Medical Systems, Inc. — Embozene Color-Advanced Microspheres (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMedimaps Group SA — TBS iNsight (V4) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoPrenuvo — Prenuvo Body Composition (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoOlympus Medical Systems Corporation — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMED-EL Elektromedizinische Geräte GmbH — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoRoche Molecular Systems, Inc. — cobas® liat CT/NG nucleic acid test (510k cleared)

    Product code: QEP. Advisory committee: Microbiology. Type: Dual Track

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMilvue — TechCare Trauma (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMedtronic, Inc. — Affera Integrated Mapping System (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoSofradim Production — ProGrip™ Self-Gripping Polypropylene Mesh (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoDraeger Medical Systems, Inc. — Babyroo TN300 (510k cleared)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoSonoscape Medical Corp. — Digital Color Doppler Ultrasound System (P60 Series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoKoh Young Technology, Inc. — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

    Product code: PAB. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoPhilips Medizin Systeme Böblingen GmbH — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoAmb Medtec — hygh-tec Drainage II (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMedtronic, Inc. — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (510k cleared)Medtronic plc

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoAccess Vascular, Inc. — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (510k cleared)

    Product code: LJS. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMED-EL Elektromedizinische Geräte GmbH — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoWilson-Cook Medical, Inc. — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (510k cleared)

    Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Special

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMedtronic Sofamor Danek, Inc. — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoSmart Denture Conversions, LLC — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (510k cleared)

    Product code: NHA. Advisory committee: Dental. Type: Abbreviated

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoGe Medical Systems Israel, Functional Imaging — Aurora (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoNeoventa Medical AB — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (510k cleared)

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

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoMyocene — Myocene (510k cleared)

    Product code: SDX. Advisory committee: Neurology. Type: Direct

    full page →fda device 510k ↗
    ›Jan 17, 2025device 510k575d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ← prev
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    $AZN156.28-0.61%
    $PFE26.61-0.73%
    $CAH232.78+0.67%
    $UTHR500.35-0.18%
    $PTON
    $KVUE19.23+0.13%
    $MMSI90.31-0.21%
    $MDT91.62+1.15%
    $FRTRY
    $AZN156.28-0.61%
    $MDT91.62+1.15%
    $MMSI90.31-0.21%