Elephant Hawk
← Chrysalis library
Start
Intelligence
Insights
Library
Context Brief
Singapore's FDA engagement reveals a tightly curated medtech ecosystem—just 27 unique sponsors producing 73 clearances over five years, but with a remarkably high-value composition skewed toward AI-enabled diagnostics, wearables, and surgical intelligence platforms. Where India's 510(k) profile spans commodity orthopedics, disposables, and contract manufacturing with breadth over sophistication, Singapore's sponsor roster reads like a venture-backed digital health incubator: nearly half the active filers operate at the AI/software-as-medical-device frontier. The two-sponsor concentration at the top—Epic Medical with 21 clearances and CMT Health with 8—suggests genuine product portfolios rather than one-off market tests, and the zero recalls over three years signals disciplined quality systems despite rapid innovation cycles. This is not a volume play; it's a precision bet on next-generation clinical intelligence tools entering the U.S. market through a city-state with deliberate life sciences policy.
| Sponsor | 5y clearances | Last 12mo | Distinct codes | First clearance | Most recent |
|---|---|---|---|---|---|
| Epic Medical Pte. , Ltd. | 21 | 5 | 5 | 2020-08-07 | 2026-06-12 |
| CMT Health PTE., Ltd. | 8 | 7 | 4 | 2025-07-18 | 2026-06-12 |
| 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 | 0 | 2 | 2021-07-27 | 2025-06-20 |
| Hill-Rom Services Pte, Ltd. | 2 | 0 | 1 | 2020-02-14 | 2020-05-26 |
| Biofourmis Singapore Pte., Ltd. | 2 | 0 | 1 | 2023-02-23 | 2024-05-09 |
| See-Mode Technologies Pte, Ltd. | 2 | 0 | 2 | 2020-09-16 | 2024-09-09 |
| Aevice Health Pte. , Ltd. | 2 | 0 | 1 | 2023-07-07 | 2025-05-05 |
| Healkee Medical Pte, Ltd. | 2 | 0 | 1 | 2024-05-16 | 2024-05-23 |
| Bioptimal International Pte. , Ltd. | 2 | 1 | 2 | 2025-06-15 | 2026-05-28 |
| 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 |
| Venner Medical (Singapore) Pte, Ltd. | 2 | 0 | 2 | 2020-02-14 | 2020-07-22 |
| Quantumtx Pte. , Ltd. | 1 | 0 | 1 | 2024-12-19 | 2024-12-19 |
| 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 |
| Pranaq Pte. , Ltd. | 1 | 0 | 1 | 2025-02-03 | 2025-02-03 |
| Serv Medical Pte., Ltd. | 1 | 0 | 1 | 2025-03-17 | 2025-03-17 |
| Ndr Medical Technology Pte. , Ltd. | 1 | 0 | 1 | 2023-06-01 | 2023-06-01 |
| Merit Medical Pte. , Ltd. | 1 | 0 | 1 | 2023-03-17 | 2023-03-17 |
| Semperit Investments Asia Pte , Ltd. | 1 | 0 | 1 | 2023-01-27 | 2023-01-27 |
| Careverse Technology Pte. , Ltd. | 1 | 1 | 1 | 2025-09-04 | 2025-09-04 |
| Medipurpose Pte. , Ltd. | 1 | 0 | 1 | 2022-09-22 | 2022-09-22 |
| 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 | 30 | 4 | 11 |
| Radiology | 13 | 7 | 2 |
| Cardiovascular | 8 | 5 | 1 |
| Anesthesiology | 7 | 4 | 1 |
| Dental | 4 | 2 | 3 |
| Gastroenterology, Urology | 3 | 2 | 1 |
| General, Plastic Surgery | 3 | 2 | 0 |
| Physical Medicine | 3 | 2 | 0 |
| Obstetrics/Gynecology | 1 | 1 | 0 |
| Clinical Chemistry | 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; 173 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 |
| BE | 1 | 1 |
| TW | 1 | 1 |
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 | — |
| NCT07353710 | A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure | Boston Scientific Corporation | Not Yet Recruiting | NA | 2026-07-01 | 200 | — |
| NCT07641491 | Silver-Impregnated Dressings for Catheter Exit-Site and Tunnel Infections in Peritoneal Dialysis Patients | Singapore General Hospital | Not Yet Recruiting | NA | 2026-06-01 | 60 | — |
| NCT07650344 | USAGE OF ARITIFICIAL INTELLIGENCE IN AIDING WITH COLONIC SESSILE SERRATED LESIONS DETECTION AND DIAGNOSIS (AI-SSL) | National Healthcare Group, Singapore | Recruiting | NA | 2026-05-21 | 628 | — |
| NCT07253064 | Study Comparing Eye Growth Over Time in Children Using Two Myopia Control Lenses | Essilor International | Active Not Recruiting | NA | 2025-11-11 | 20 | — |
| NCT07291817 | Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study | Lo Zhiwen Joseph | Recruiting | NA | 2025-11-03 | 30 | — |
| 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 | — |
| NCT07255859 | AVIGA3 (Cohort 2.0) | Tan Tock Seng Hospital | Recruiting | NA | 2025-06-16 | 60 | — |
| NCT06832631 | VITUS Post-Market Registry | OrbusNeich | Active Not Recruiting | — | 2025-05-22 | 284 | — |
| NCT06686485 | cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia | Boston Scientific Corporation | Recruiting | — | 2025-03-18 | 433 | — |
| 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 | — |
| NCT06216301 | LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC | NovoCure GmbH | Recruiting | PHASE3 | 2024-07-31 | 734 | — |
| 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 | — |
| NCT06096337 | Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation | Boston Scientific Corporation | Active Not Recruiting | NA | 2023-12-28 | 484 | — |
| 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 | — |
| NCT06148870 | Comparison of Efficacy Between Two Myopia Control Lenses | Essilor International | Completed | NA | 2023-11-29 | 50 | — |
| 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 | — |
| NCT05476926 | A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products | Hoffmann-La Roche | Active Not Recruiting | — | 2022-11-21 | 6,000 | — |
| NCT05606068 | A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study | National University Hospital, Singapore | Recruiting | NA | 2022-11-11 | 200 | — |
| NCT05491109 | Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke Patients | National University Hospital, Singapore | Completed | NA | 2022-09-01 | 19 | — |
| NCT05724264 | SingapOre Lung Cancer Screening Through Integrating CT With Other biomarkErs (SOLSTICE) | National Cancer Centre, Singapore | Recruiting | NA | 2022-07-21 | 1,000 | — |
| NCT05095051 | A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy | National University Hospital, Singapore | Completed | NA | 2021-11-03 | 15 | — |
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
10.64898/2026.07.15.26358208
|
Bridging surveillance gaps in dengue: a hierarchical model integrating mixed data sources for transmission estimation and vaccine targeting |
Swapnil Mishra
Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore…
|
epidemiology | 2026-07-17 | Published |
|
biorxiv
10.64898/2026.07.15.738638
|
Cross-phosphorylation of RR06 by the non-cognate kinase VncS activates the adhesin CbpA in Streptococcus pneumoniae. |
Lok-To Sham
National University of Singapore
|
microbiology | 2026-07-16 | Published |
|
medrxiv
10.64898/2026.07.08.26357531
|
Caregivers formal digital proxy roles and engagement in advance care planning: A cross-sectional study |
Vinh Anh Huynh
National University Singapore Saw Swee Hock School of Public Health
|
public and global health | 2026-07-13 | Published |
|
medrxiv
10.64898/2026.07.10.26357712
|
Spatial Analysis Uncovers Immune Resistance Mechanisms in Non-Beneficial Hepatocellular Carcinoma Treated with Y90 Radioembolization-Nivolumab |
Mai Chan Lau PhD
1Bioinformatics Institute (BII), Agency for Science, Technology and Research (A*STAR), Singapore 138671 2Singapore Immun…
|
oncology | 2026-07-13 | Published |
|
medrxiv
10.64898/2026.07.06.26357372
|
Personalized Definition of Short Sleep Using Long-Term Wearable Sleep Distributions |
Michael W.L. Chee
National University of Singapore
|
public and global health | 2026-07-09 | Published |
|
medrxiv
10.64898/2026.07.02.26357089
|
Robust Longitudinal Dementia Prediction under Systemic Missingness via Hierarchical Fusion and Test-Time Adaptation |
B.T. Thomas Yeo
National University of Singapore
|
health informatics | 2026-07-06 | Published |
|
biorxiv
10.64898/2026.07.02.735997
|
Accessible spatial host-microbe profiling in tumour tissues |
Minghao Chia
Genome Institute of Singapore
|
microbiology | 2026-07-03 | Published |
|
medrxiv
10.64898/2026.06.26.26356650
|
Robustness of Wolbachia-mediated incompatible-insect technique to future climate change scenarios |
Jue Tao Lim
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore
|
public and global health | 2026-06-30 | Published |
|
biorxiv
10.64898/2026.06.26.734804
|
RNArefine: AI-guided Atomic-Level Refinement of RNA Structures |
Yang Zhang
Department of Computer Science, School of Computing, National University of Singapore
|
bioengineering | 2026-06-29 | Published |
|
medrxiv
10.64898/2026.06.17.26354669
|
Hepatic Fibro-Inflammation and Atrial Fibrillation: A Dual-Track Metabolic Axis Revealed by a Metabolomic Clock |
Xiao Liu
Duke-National University of Singapore Medical School
|
cardiovascular medicine | 2026-06-26 | Published |
|
medrxiv v4
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 | 2026-06-25 | Published |
|
medrxiv
10.64898/2026.06.15.26355645
|
Cardiometabolic risk phenogroups from a data-driven classification with expanded risk factors |
Roger SY Foo
National University Singapore
|
cardiovascular medicine | 2026-06-24 | Published |
|
biorxiv
10.64898/2026.06.22.733919
|
Symptomatic human norovirus infection in zebrafish embryos uncovers neural infection and extracellular vesicle-mediated transmission dynamics |
Dan Li
National University of Singapore
|
microbiology | 2026-06-23 | Published |
|
medrxiv
10.64898/2026.06.19.26356074
|
Clinical-grade Cuffless Blood Pressure Monitoring via Deep-tissue Diffuse Speckle Pulsatile Flowmetry |
Renzhe Bi
A*STAR Skin Research Labs, Agency for Science, Technology and Research, Singapore
|
cardiovascular medicine | 2026-06-22 | Published |
|
biorxiv
10.64898/2026.06.19.733351
|
A beneficial megaplasmid transforms an opportunistic bacterial pathogen to benefit coral by extending their thermal range |
Rebecca Josephine Case
Nanyang Technological University, Singapore
|
microbiology | 2026-06-19 | Published |
|
medrxiv v5
10.64898/2026.05.14.26353252
|
MyeGPT: an AI agent for Multiple Myeloma |
Jia Geng Chang
Department of Medicine, National University of Singapore
|
hematology | 2026-06-14 | Published |
|
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 |