Aletia Index
Clinical Assurance
Index
About
Methodology
For Clinicians
For Regulators
Take tour
Index
Methodology
Insights
For Clinicians
Request Review
Live Regulatory Index
AI/ML Medical Device
Index
Total
1,267
indexed records
FDA
1,175
US records
MHRA
58
UK records
EU MDR
2
EU records
PCCP
53
authorised
Pipeline
27
trial / review
Tool
Description
Regulatory Status
Risk
Last sync
Loading…
Transparent Methodology
We publish evaluation criteria, assessment process, and evidence grading standards.
View methodology
All Specialties
Anaesthesiology
Cardiology
Dentistry
Dermatology
Endocrinology
Gastroenterology
Hematology
Intensive Care
Nephrology
Neurology
Obstetrics & Gynaecology
Oncology
Ophthalmology
Orthopaedics
Otolaryngology
Paediatrics
Pathology
Psychiatry
Pulmonology
Radiology
Rheumatology
Urology
All Sources
Registry Sync
Aletia Research
Manufacturer Submitted
Showing
53
of 1,267 indexed ·
Browse all 1,267 →
·
27 in pipeline
All devices
✓ PCCP Authorized
⬡ Autonomous Output
🔬 Pipeline
27
All Status
Green Status
Amber Status
Red Status
Tool
Description
Regulatory Status
Risk
Last sync
PVAD IQ Software
Ultrasight , Ltd.
· ALT-006136
FDA
PVAD IQ Software
510k
—
Mar 2026
View
UltraSight Guidance
Ultrasight , Ltd.
· ALT-006134
FDA
UltraSight Guidance
510k
—
Mar 2026
View
Personalized Therapy Comfort Settings (PTCS)
ResMed Corp
· ALT-006132
FDA
Personalized Therapy Comfort Settings (PTCS)
510k
—
Mar 2026
View
Showing 51–53 of 53
← Prev
3 / 3
Next →