Intelligent Bio Solutions
Medical technology company developing rapid, non-invasive biochemical screening using sweat (fingerprint samples and wearable patches) and a printable biosensor platform for saliva diagnostics. The company develops point-of-care screening hardware and single‑use consumables, conducts multi-site method comparison, interference, usability and precision validation studies to support FDA 510(k) regulatory clearance, maintains medical device quality management certifications (ISO 13485), operates an international distributor channel, and publishes product security and usability documentation.
Industries
Nr. of Employees
medium (51-250)
Intelligent Bio Solutions
Products
Fingerprint sweat-based drug screening system
Point-of-care system combining single-use lateral-flow fluorescence screening cartridges with a portable fluorescence reader to detect recent drug use from fingertip sweat.
Wearable sweat patch for continuous drug monitoring
Discrete, tamper-evident, water-resistant wearable patch that collects sweat continuously over 7–10 days to detect a broad panel of substances for longer-term monitoring.
Printable OTFT saliva diagnostic strips
Organic thin-film transistor biosensor strip architecture intended for adaptation to saliva-based diagnostic assays and manufactured at scale via printing processes.
Intelligent Fingerprinting Drug Screening System
A comprehensive two-part on-site screening solution consisting of single-use Drug Screening Cartridges and a portable Drug Screening Reader that analyzes fingertip sweat to detect recent drug misuse.
SmarTest Sweat Drug Testing Patch
A discreet, wearable device that detects drug use through sweat over a 7 to 10-day period for longer-term monitoring.
SmarTest Patch
A discreet, wearable device that enables continuous drug detection over a 7 to 10-day period by collecting sweat in real time to monitor for a broad range of substances.
Fingerprint sweat-based drug screening system
Point-of-care system combining single-use lateral-flow fluorescence screening cartridges with a portable fluorescence reader to detect recent drug use from fingertip sweat.
Wearable sweat patch for continuous drug monitoring
Discrete, tamper-evident, water-resistant wearable patch that collects sweat continuously over 7–10 days to detect a broad panel of substances for longer-term monitoring.
Printable OTFT saliva diagnostic strips
Organic thin-film transistor biosensor strip architecture intended for adaptation to saliva-based diagnostic assays and manufactured at scale via printing processes.
Intelligent Fingerprinting Drug Screening System
A comprehensive two-part on-site screening solution consisting of single-use Drug Screening Cartridges and a portable Drug Screening Reader that analyzes fingertip sweat to detect recent drug misuse.
SmarTest Sweat Drug Testing Patch
A discreet, wearable device that detects drug use through sweat over a 7 to 10-day period for longer-term monitoring.
SmarTest Patch
A discreet, wearable device that enables continuous drug detection over a 7 to 10-day period by collecting sweat in real time to monitor for a broad range of substances.
Services
Training of nominated personnel for supervised point-of-care screening, chain-of-custody procedures, and integration with confirmatory laboratory workflows.
Distributor onboarding resources including brand guidelines, product images, sales and marketing materials, product guides and demonstration media.
Structured vulnerability disclosure process for reader firmware/software including a reporting form, email reporting route, acknowledgement and investigation timelines, and remediation publication.
Operational management and execution support for multi-site method comparison, interference, usability and precision studies intended to generate evidence for regulatory submissions.
Training of nominated personnel for supervised point-of-care screening, chain-of-custody procedures, and integration with confirmatory laboratory workflows.
Distributor onboarding resources including brand guidelines, product images, sales and marketing materials, product guides and demonstration media.
Structured vulnerability disclosure process for reader firmware/software including a reporting form, email reporting route, acknowledgement and investigation timelines, and remediation publication.
Operational management and execution support for multi-site method comparison, interference, usability and precision studies intended to generate evidence for regulatory submissions.
Expertise Areas
- Point-of-care diagnostic screening
- Wearable biosensing for continuous monitoring
- Clinical study design and multi-site validation
- Regulatory compliance and medical device quality systems (ISO 13485)
Key Technologies
- Fingerprint sweat analysis
- Lateral-flow immunoassays
- Fluorescence-based detection
- Portable analytical readers
News & Updates
Submission of a 510(k) premarket notification to the U.S. FDA seeking regulatory clearance for the fingerprint sweat-based drug screening system.
Completion of a multi-site method comparison study to support the 510(k) submission for the fingerprint sweat-based screening system.
Recertification to the ISO 13485:2016 quality management system standard for the medical device business.
Completion of a usability study for the fingerprint sweat-based screening system to support the 510(k) submission.
Completion of an interference study examining the impact of common substances on system performance to support regulatory submission.
Completion of precision and performance testing as part of the data package for the 510(k) submission.
Submission of a 510(k) premarket notification to the U.S. FDA seeking regulatory clearance for the fingerprint sweat-based drug screening system.
Completion of a multi-site method comparison study to support the 510(k) submission for the fingerprint sweat-based screening system.
Recertification to the ISO 13485:2016 quality management system standard for the medical device business.
Completion of a usability study for the fingerprint sweat-based screening system to support the 510(k) submission.
Completion of an interference study examining the impact of common substances on system performance to support regulatory submission.
Completion of precision and performance testing as part of the data package for the 510(k) submission.