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17,898 catalysts · 4,728 grant · 3,230 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 60 catalysts2026-08-14: 4 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
  • 8k filing3,230
  • approval2,606
  • device 510k2,051
  • device recall1,649
  • device pma1,418
device adverse event
1,000
  • earnings584
  • recall551
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Sep 8, 2025

    24
    ›Sep 12, 2025grant336d agoIMAGEN BIOWORKS INC. — Scalable spatiotemporal-omics platform

    GM grant. $349,243. PI: Jihwan Lee

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoJOHNS HOPKINS UNIVERSITY — Periodontal Disease and Small Vulnerable Newborns: A Cluster Randomized TrialJohns Hopkins University

    HD grant. $19,610. PI: Daniel Joseph Erchick

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoUNIVERSITY OF CHICAGO — Spatiomolecular Profiling of Human Cancer at Scale

    CA grant. $372,628. PI: Nicolas Chevrier

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoUNIVERSITY OF CENTRAL FLORIDA — Vagal and spinal afferent mapping of rat and human hearts in health and disease

    HL grant. $726,035. PI: ZIXI Jack CHENG

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Phthalates and Phthalate Alternatives and Early Human Cardiometabolic Develop...

    ES grant. $249,000. PI: Danielle Stevens

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — A contraceptive decision support tool and maternal and child outcomes

    HD grant. $453,978. PI: Sarah D Compton

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoICAHN SCHOOL OF MEDICINE AT MOUNT SINAI — Defining the Role of ANKEF1 in Ciliary Function and Host Defense Against Infl...

    AI grant. $856,791. PI: Lisa Miorin

    full page →nih reporter ↗
    ›Sep 12, 2025grant336d agoEMORY UNIVERSITY — HEG1 as a regulator of hypertension and atherosclerosisEmory University

    HL grant. $78,040. PI: Michael David Clark

    full page →nih reporter ↗
    ›Sep 13, 2025device 510k335d agoBrainsway , Ltd. — BrainsWay Deep TMS System (510k cleared)Brainsway Ltd.

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

    full page →fda device 510k ↗
    ›Sep 13, 2025grant335d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — ONWARD: Optimizing Navigation for Wellness And Resource utilization in youth ...

    DK grant. $343,954. PI: Maya Ragavan

    full page →nih reporter ↗
    ›Sep 13, 2025grant335d agoWASHINGTON UNIVERSITY — Healthy Behaviors for Insomnia Prevention in People with HIV and Ongoing Pain...

    MD grant. $1,242,010. PI: Burel R. Goodin

    full page →nih reporter ↗
    ›Sep 13, 2025grant335d agoIMPACT RESEARCH AND DEVELOPMENT ORG — A Multilevel Intervention to Reduce PrEP Stigma and Increase Effective PrEP U...

    TW grant. $234,292. PI: Mark Ayallo

    full page →nih reporter ↗
    ›Sep 13, 2025grant335d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Addressing Severe Maternal Morbidity of Deaf and Hard of Hearing Individuals ...

    HD grant. $1,573,144. PI: Ilhom Akobirshoev

    full page →nih reporter ↗
    ›Sep 13, 2025grant335d agoUNIVERSITY OF CALIFORNIA, SAN FRANCISCO — Improving retention along the hypertension care cascade and reducing cardiova...University of California San Francisco

    MD grant. $897,989. PI: ELISE D. RILEY

    full page →nih reporter ↗
    ›Sep 13, 2025grant335d agoYALE UNIVERSITY — Pathogenic mechanisms of obesity and its cardiometabolic complicationsMetallomix Inc

    DK grant. $802,843. PI: Nicola Santoro

    full page →nih reporter ↗
    ›Sep 14, 2025device 510k334d agoTeleemg, LLC — CloudTMS Edge (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 14, 2025grant334d agoNEW YORK UNIVERSITY — Making caries prevention SMART: Adaptive interventions for precision dental m...New York University

    MD grant. $2,921,992. PI: RYAN RICHARD RUFF

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Scr...

    MD grant. $165,012. PI: Lisa Nicole Mansfield

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoUNIVERSITY OF ILLINOIS AT CHICAGO — FIM+DASH: A randomized Food Is Medicine trial to promote healthy eating and b...

    MD grant. $2,979,575. PI: Saria Lofton

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoSTATE UNIVERSITY OF NEW YORK AT BUFFALO — Comparative effectiveness of food prescription programs for food insecure fam...

    MD grant. $680,103. PI: Lucia A Leone

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoUNIVERSITY OF ROCHESTER — The Impact of Social Connectedness on Suicide Risk in Adults in Middle to La...University of Rochester

    MD grant. $677,562. PI: Caroline Silva

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoUNIVERSITY OF KANSAS MEDICAL CENTER — Bioenergetic Contributions to Tau Phosphorylation in Aging and Alzheimer DiseaseUniversity of Kansas Medical Center

    AG grant. $38,596. PI: Riley Kemna

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoUNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON — Delivery of a Culturally Tailored Exercise Training Intervention for Hispanic...

    MD grant. $2,825,047. PI: Stephanie Silveira Gee

    full page →nih reporter ↗
    ›Sep 14, 2025grant334d agoUNIVERSITY OF ROCHESTER — The Impact of Social Connectedness on Suicide Risk in Adults in Middle to La...University of Rochester

    MD grant. $702,089. PI: Caroline Silva

    full page →nih reporter ↗

    Week of Sep 15, 2025

    26
    ›Sep 15, 2025approval333d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

    Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

    full page →fda approvals ↗
    ›Sep 15, 2025device 510k
    ← prev
    page 25 of 358
    next →
    333d ago
    Sober Ip, LLC — Sober Self-Test (510k cleared)

    Product code: DIC. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoSI-BONE, Inc. — iGPS Navigation Instruments (510k cleared)SI-BONE, Inc.

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoShanghai AnQing Medical Instrument Co., Ltd. — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoMiley Technology (Hebei) Co., Ltd. — IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoPremium Plus (Dongguan) Limited — Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoG21, S.R.L. — SpaceFix Shoulder Spacer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoBeijing Infervision Healthcare Medical Technology Co., Ltd. — InferOperate Suite (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device 510k333d agoUvx, Inc. — Zener® (model ZEN-001-B1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 15, 2025device pma333d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoAbiomed, Inc. — Purge Cassette (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic Vascular — Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (PMA supplement)

    Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoBiotronik, Inc. — Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140; Enitra 8 HF-T QP 407141; Enitr (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoBiotronik, Inc. — Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoAbiomed, Inc. — Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (PMA supplement)Abion Inc

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoBiotronik, Inc. — Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462 (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoBausch and Lomb, Inc., — ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoBiosense Webster, Inc. — SMARTABLATE™ System Interface Cable (D-1303-02-S) (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic Neuromodulation — Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (PMA supplement)

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

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

    Supplement type: Real-Time Process. Product code: SBB. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 15, 2025device pma333d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    $BWAY
    $SIBN13.41+15.55%
    $MDT91.10+0.37%