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Context Brief
Singapore's FDA footprint is small in absolute terms—69 clearances over five years, 1.1% of all foreign submissions in the trailing twelve months—but its sponsor composition is unusually concentrated in high-value, computationally intensive product categories. Unlike India, which fields a broad mix of commodity surgical instruments, diagnostic reagents, and contract manufacturing across dozens of sponsors, Singapore's 27 unique applicants skew heavily toward AI-enabled diagnostics, connected wearables, and software-as-a-medical-device platforms. The Epic Medical outlier (20 clearances, mostly orthopedic implants and instruments) aside, Singapore's regulatory strategy appears deliberate: sponsors are placing narrow, defensible bets on algorithmic differentiation rather than competing on manufacturing scale. Zero recalls in three years further suggests disciplined quality systems and mature risk management—characteristics of sponsors building for acquisition or partnership rather than volume commoditization.
| Sponsor | 5y clearances | Last 12mo | Distinct codes | First clearance | Most recent |
|---|---|---|---|---|---|
| Epic Medical Pte. , Ltd. | 20 | 4 | 4 | 2020-08-07 | 2026-04-24 |
| CMT Health PTE., Ltd. | 6 | 6 | 4 | 2025-07-18 | 2026-04-08 |
| Nsp Tech Pte, Ltd. | 3 | 0 | 2 | 2020-04-21 | 2022-10-24 |
| Biobot Surgical Pte., Ltd. | 3 | 0 | 1 | 2021-07-08 | 2023-12-21 |
| Claritas Healthtech Pte, Ltd. | 3 | 1 | 1 | 2021-10-20 | 2025-08-05 |
| Good Sleep CO Pte , Ltd. | 3 | 2 | 1 | 2024-05-09 | 2025-11-25 |
| Eko.Ai Pte Ltd. D/B/A Us2.Ai | 3 | 1 | 2 | 2021-07-27 | 2025-06-20 |
| See-Mode Technologies Pte, Ltd. | 2 | 0 | 2 | 2020-09-16 | 2024-09-09 |
| Smartmissimo Technologies Pte, Ltd. | 2 | 0 | 1 | 2021-02-23 | 2021-07-30 |
| Respiree Pte, Ltd. | 2 | 1 | 1 | 2023-03-08 | 2025-08-05 |
| Aevice Health Pte. , Ltd. | 2 | 0 | 1 | 2023-07-07 | 2025-05-05 |
| Hill-Rom Services Pte, Ltd. | 2 | 0 | 1 | 2020-02-14 | 2020-05-26 |
| Venner Medical (Singapore) Pte, Ltd. | 2 | 0 | 2 | 2020-02-14 | 2020-07-22 |
| Healkee Medical Pte, Ltd. | 2 | 0 | 1 | 2024-05-16 | 2024-05-23 |
| Biofourmis Singapore Pte., Ltd. | 2 | 0 | 1 | 2023-02-23 | 2024-05-09 |
| Serv Medical Pte., Ltd. | 1 | 0 | 1 | 2025-03-17 | 2025-03-17 |
| Merit Medical Pte. , Ltd. | 1 | 0 | 1 | 2023-03-17 | 2023-03-17 |
| Quantumtx Pte. , Ltd. | 1 | 0 | 1 | 2024-12-19 | 2024-12-19 |
| Careverse Technology Pte. , Ltd. | 1 | 1 | 1 | 2025-09-04 | 2025-09-04 |
| Bioptimal International Pte. , Ltd. | 1 | 1 | 1 | 2025-06-15 | 2025-06-15 |
| Medipurpose Pte. , Ltd. | 1 | 0 | 1 | 2022-09-22 | 2022-09-22 |
| Pranaq Pte. , Ltd. | 1 | 0 | 1 | 2025-02-03 | 2025-02-03 |
| Ndr Medical Technology Pte. , Ltd. | 1 | 0 | 1 | 2023-06-01 | 2023-06-01 |
| Sg Endoscopy Pte, Ltd. | 1 | 0 | 1 | 2025-05-02 | 2025-05-02 |
| Hannah Life Technologies Pte , Ltd. | 1 | 0 | 1 | 2023-12-21 | 2023-12-21 |
| Semperit Investments Asia Pte , Ltd. | 1 | 0 | 1 | 2023-01-27 | 2023-01-27 |
| Ram.Shaw Pte. , Ltd. | 1 | 1 | 1 | 2026-03-03 | 2026-03-03 |
What Singapore sponsors actually file. The AI/Radiology + Cardiovascular tilt is the giveaway — this is not a country exporting orthopedic commodity or sterile supply, it's exporting software-driven device.
| Specialty | 5y clearances | Unique sponsors | Last 12mo |
|---|---|---|---|
| General Hospital | 27 | 4 | 8 |
| Radiology | 13 | 7 | 2 |
| Cardiovascular | 7 | 5 | 2 |
| Anesthesiology | 7 | 4 | 1 |
| Dental | 4 | 2 | 3 |
| Physical Medicine | 3 | 2 | 0 |
| Gastroenterology, Urology | 3 | 2 | 2 |
| General, Plastic Surgery | 3 | 2 | 0 |
| Clinical Chemistry | 1 | 1 | 0 |
| Obstetrics/Gynecology | 1 | 1 | 0 |
510(k) Summary PDFs reveal each SG sponsor's substantial-equivalence basis. 61 of 63 parsed SG filings have at least one citation; 169 citations total. Because SG sponsors are AI-heavy, expect their predicates to skew US-AI-incumbent.
| Predicate's HQ country | Distinct SG filers citing | Total citations |
|---|---|---|
| SG | 24 | 59 |
| US | 14 | 15 |
| CN | 6 | 6 |
| NL | 4 | 4 |
| GB | 3 | 3 |
| IE | 1 | 1 |
| KR | 1 | 1 |
| DK | 1 | 1 |
| TW | 1 | 1 |
| CH | 1 | 1 |
| Sponsor (cited) | HQ country | Cited by SG filers | Total citations | Codes touched |
|---|---|---|---|---|
| Epic Medical Pte. , Ltd. | SG | 15 | 50 | FPA, KPE, ONB |
| Vertex-Dental B.V. | NL | 4 | 4 | EBI |
| Promisemed Hangzhou Meditech Co., Ltd. | CN | 2 | 2 | FMF, FMK |
| Invictus Lighting | US | 2 | 2 | FRA |
| Azur Medical Company, Inc. | US | 2 | 2 | FMF, FMI |
| Biobot Surgical Pte., Ltd. | SG | 2 | 2 | IYO |
| Eko Devices, Inc. | US | 2 | 2 | DQD |
| Medexel Co.,Ltd | KR | 1 | 1 | QNQ |
| Storz Medical AG | CH | 1 | 1 | IPF |
| Biofourmis Singapore Pte., Ltd. | SG | 1 | 1 | MSX |
| Ultromics Limited | GB | 1 | 1 | SDJ |
| Taihao Medical, Inc. | TW | 1 | 1 | QDQ |
| Eko.Ai Pte Ltd. D/B/A Us2.Ai | SG | 1 | 1 | QIH |
| Hill-Rom Services Pte, Ltd. | SG | 1 | 1 | NHJ |
| Siemens Medical Solution USA, Inc. | US | 1 | 1 | LLZ |
| Current Health | GB | 1 | 1 | MSX |
| Strados Labs, Inc. | US | 1 | 1 | DSH |
| Ectosense NV | BE | 1 | 1 | MNR |
| Ensodata | US | 1 | 1 | MNR |
| Respiree Pte, Ltd. | SG | 1 | 1 | BZQ |
| Aevice Health Pte. , Ltd. | SG | 1 | 1 | DSH |
| Claritas Healthtech Pte, Ltd. | SG | 1 | 1 | LLZ |
| Vitls, Inc. | US | 1 | 1 | DRG |
| Bk Medical Aps | DK | 1 | 1 | IYN |
| Good Sleep CO Pte , Ltd. | SG | 1 | 1 | LRK |
| Cleerly, Inc. | US | 1 | 1 | LLZ |
| Greystone Ip, Ltd. | IE | 1 | 1 | LRK |
| Brainomix Limited | GB | 1 | 1 | LLZ |
| Koios Medical, Inc. | US | 1 | 1 | POK |
| Ningbo Tianyi Medical Appliance Co., Ltd. | CN | 1 | 1 | PNR |
Studies with at least one Singapore location, last 5y.
| NCT | Title | Sponsor | Status | Phase | Started | N | Results |
|---|---|---|---|---|---|---|---|
| NCT07595497 | Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI | National University Hospital, Singapore | Not Yet Recruiting | NA | 2027-01-01 | 24 | — |
| NCT07038369 | A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations | Atavistik Bio, Inc | Active Not Recruiting | PHASE1 | 2025-07-29 | 134 | — |
| NCT06632457 | LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis | Boehringer Ingelheim | Recruiting | PHASE3 | 2024-11-07 | 1,590 | — |
| NCT06632444 | LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis | Boehringer Ingelheim | Recruiting | PHASE3 | 2024-09-17 | 1,800 | — |
| NCT06219707 | Electro-acupuncture for Irritable Bowel Syndrome With Constipation | Nanyang Technological University | Completed | NA | 2024-09-12 | 60 | — |
| NCT06274801 | Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) | GB002, Inc. | Active Not Recruiting | PHASE3 | 2024-09-03 | 316 | — |
| NCT06540716 | Inspire Singapore Study | Inspire Medical Systems, Inc. | Completed | NA | 2024-07-25 | 44 | — |
| NCT05902871 | Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population | BelkinVision | Active Not Recruiting | NA | 2024-03-11 | 40 | — |
| NCT05934526 | Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) | GB002, Inc. | Completed | PHASE3 | 2023-12-28 | 390 | — |
| NCT06065748 | A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) | Hoffmann-La Roche | Recruiting | PHASE3 | 2023-12-11 | 1,050 | — |
| NCT05846893 | Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease | B. Braun Medical Industries Sdn. Bhd. | Active Not Recruiting | NA | 2023-09-07 | 1,436 | — |
| NCT05564754 | Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation | Region Skane | Active Not Recruiting | NA | 2023-08-17 | 3,500 | — |
| NCT07579390 | Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) | Helsinki University Central Hospital | Active Not Recruiting | NA | 2023-08-17 | 3,500 | — |
| NCT05995665 | Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients | Alexandra Hospital | Completed | NA | 2023-07-11 | 61 | — |
| NCT05724264 | SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE) | National Cancer Centre, Singapore | Recruiting | NA | 2022-07-21 | 1,000 | — |
| NCT04253392 | RETHINK REFLUX Registry | Ethicon Endo-Surgery | Active Not Recruiting | — | 2020-07-08 | 500 | — |
| NCT04224493 | A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma. | Epizyme, Inc. | Active Not Recruiting | PHASE3 | 2020-06-11 | 599 | — |
| NCT01754363 | Survivorship of Attune Primary Total Knee Prosthesis | DePuy International | Active Not Recruiting | NA | 2013-02-01 | 1,542 | — |
Papers with Singapore author affiliations, last 5y.
| PMID | Title | Journal | Authors | Date | Why |
|---|---|---|---|---|---|
| 42207915 · DOI | AI-assisted teams outperform AI-led teams but not human-only teams in assessing research reproducibility in quantitative social science. | Proceedings of the National Academy of Sciences of the United States of America | A Castillo Alvarez G, Abdelhady M, Abdelmoula Y, Aguirre T et al. | 2026-06-02 | Sponsor |
| 42207433 · DOI | Exploration of Real-World Data Sources in Latin America, Middle East and North Africa, and Asia Pacific, to Support Oncology Evidence Generation: A Targeted Literature Review and Regional Recommendations. | Advances in therapy | Bazarbashi S, Chiu A, Dreyer N, Ghai C et al. | 2026-05-28 | Sponsor |
| 42208254 · DOI | The impact of China's environmental regulations on carbon intensity. | Journal of environmental management | Chen XH, Gater G, Tee K | 2026-05-28 | Sponsor |
| 42214646 · DOI | The present and the future of risk stratification for and prevention of sudden cardiac death: A Heart Rhythm Society think tank meeting. | Heart rhythm | Ackerman MJ, Al-Khatib SM, Albert CM, Califf RM et al. | 2026-05-28 | Sponsor+KW |
| 41832618 · DOI | Result harmonization in medical laboratories: accomplishments and challenges. | Clinical chemistry and laboratory medicine | Badrick T, Beasley-Green A, Cobbaert CM, Delatour V et al. | 2026-05-26 | Sponsor |
| 42199063 · DOI | Normocalcemic primary hyperparathyroidism: an update on diagnostic and management challenges. | Current opinion in endocrinology, diabetes, and obesity | Chandran M, Doshi KB | 2026-05-26 | Sponsor |
| 42189295 · DOI | Comparing clinical practice guidelines on the prevention and management of chemotherapy-induced hand-foot syndrome. | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer | Alkhaifi M, Chan A, Chan AW, Chan DCW et al. | 2026-05-26 | Sponsor |
| 42191703 · DOI | Convergent and divergent brain-cognition development in early adolescence. | Nature communications | Dhamala E, Di Martino A, Floris DL, Holmes AJ et al. | 2026-05-26 | Sponsor |
| 42184810 · DOI | The Lancet Commission on precision health: equitable, data-driven health outcomes for all. | Lancet (London, England) | Abedalthagafi MS, Ali R, Chotirmall SH, Ford J et al. | 2026-05-25 | Sponsor |
| 42199250 · DOI | High-frequency Ultrasound-assisted Lymphovenous Anastomosis for Male Breast Cancer Lymphedema. | Plastic and reconstructive surgery. Global open | Abdelrahman M, Boey J, Li G, Linsley J et al. | 2026-05-01 | Sponsor |
Pre-prints whose corresponding-author institution is in Singapore. Leading-edge signal.
| DOI / Platform | Title | Corresponding author + institution | Category | Posted | Peer-reviewed? |
|---|---|---|---|---|---|
|
medrxiv
10.64898/2026.06.01.26354666
|
Shared Genetic Architecture of Psychosis, Mood, and Cognition in East Asian Ancestry |
Max Lam
Institute of Mental Health, Singapore
|
psychiatry and clinical psychology | 2026-06-03 | Published |
|
medrxiv v3
10.1101/2025.07.31.25332054
|
Metabolism of the antioxidant micronutrient ergothioneine as a plasma biomarker of cognitive resilience in older people with Alzheimer's disease amyloid pathology |
Mitchell K. P. Lai
Yong Loo Lin School of Medicine, National University of Singapore
|
neurology | 2026-06-03 | Published |
|
medrxiv v3
10.1101/2025.09.07.25335273
|
Patient Experiences with Diagnostic Revision in Lymphoma: Analysis of Chinese Online Forum Narratives Using Natural Language Processing |
Feng He
National University of Singapore
|
health systems and quality improvement | 2026-05-29 | Published |
|
medrxiv v4
10.64898/2026.05.14.26353252
|
MyeGPT: an AI agent for Multiple Myeloma |
Wee Joo Chng
National University of Singapore
|
hematology | 2026-05-29 | Published |
|
medrxiv
10.64898/2026.05.24.26353970
|
Neutrophil-primed immunopathology in poorly-controlled diabetes worsens matrix destruction in pulmonary tuberculosis |
Catherine W.M. Ong
Infectious Diseases Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National …
|
respiratory medicine | 2026-05-26 | Published |
|
medrxiv
10.64898/2026.05.24.26353997
|
Randomised Trial of a Multilingual Conversational AI for Preoperative Education |
Nan Liu
Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore
|
anesthesia | 2026-05-26 | Published |
|
medrxiv v3
10.64898/2026.05.14.26353252
|
MyeGPT: an AI agent for Multiple Myeloma |
Wee Joo Chng
National University of Singapore
|
hematology | 2026-05-24 | Published |
|
medrxiv v2
10.64898/2026.05.14.26353252
|
MyeGPT: an AI agent for Multiple Myeloma |
Wee Joo Chng
National University of Singapore
|
hematology | 2026-05-23 | Published |
|
medrxiv
10.64898/2026.05.19.26353633
|
Retrospective cohort study extracting coexisting background breast-lesion features from stage I-III invasive breast cancer |
Jingmei Li
Genome Institute of Singapore (GIS), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore
|
oncology | 2026-05-22 | Published |
|
biorxiv
10.64898/2026.05.19.726422
|
A confining microfluidic platform for disparate density coculture reveals the dynamics of macrophage-mediated adipocyte clearance |
Andrew Holle
Mechanobiology Institute, National University of Singapore
|
bioengineering | 2026-05-21 | Published |
|
medrxiv
10.64898/2026.05.19.26353490
|
Language-dependent diagnostic safety of medical AI systems: a cross-lingual benchmarking and prospective clinical study |
Dianbo Liu
Yong Loo Lin School of Medicine and College of Design and Engineering, NUS, Singapore
|
health informatics | 2026-05-21 | Published |
|
medrxiv
10.64898/2026.05.17.26353409
|
Accuracy and Consistency of Frontier LLMs on Orthodontic Diagnostic Tasks: A Repeated-Trial Comparison |
KELVIN W. C. FOONG
National University Of Singapore
|
health informatics | 2026-05-20 | Published |
|
medrxiv
10.64898/2026.05.14.26353252
|
MyeGPT: an AI agent for Multiple Myeloma |
Wee Joo Chng
National University of Singapore
|
hematology | 2026-05-20 | Published |