SpectraDx
pectraDx
light to insight
SpectraDxlight to insight

Blog

Technical Resources

Genuine technical articles for spectroscopy professionals. Not marketing fluff.

Raman Bacterial ID and AST: Rapid Spectroscopy Diagnostics
Clinical

Raman Bacterial ID and AST: Rapid Spectroscopy Diagnostics

Raman spectroscopy identifies bacterial species and delivers antimicrobial susceptibility results in hours, not days - the science, evidence, and integration.

15 min readRead article →
FDA LDT Ruling and Spectroscopy Diagnostics: What Changed
Regulatory

FDA LDT Ruling and Spectroscopy Diagnostics: What Changed

FDA LDT rule rescission reshapes spectroscopy diagnostic strategy. Decision framework for choosing between LDT, 510(k), and De Novo regulatory pathways.

14 min readRead article →
Automating Spectroscopy QC Workflows in Pharmaceutical Manufacturing: Multi-Vendor, Multi-Site, Fully Compliant
Clinical

Automating Spectroscopy QC Workflows in Pharmaceutical Manufacturing: Multi-Vendor, Multi-Site, Fully Compliant

Pharma spectroscopy QC automation across multi-vendor instrument fleets - unified workflows, 21 CFR Part 11 compliance, validation cost savings, and multi-site deployment.

20 min readRead article →
FHIR R4 Spectroscopy Integration: Sending Results to EHRs
Integration

FHIR R4 Spectroscopy Integration: Sending Results to EHRs

Map spectroscopy results to FHIR R4 resources — DiagnosticReport, Observation, Specimen, and Device — with working TypeScript and Python code for Epic.

11 min readRead article →
Thermo Fisher OMNIC Integration: Automating Nicolet FTIR and DXR Raman for Clinical Workflows
Integration

Thermo Fisher OMNIC Integration: Automating Nicolet FTIR and DXR Raman for Clinical Workflows

Thermo Fisher OMNIC integration covering the Paradigm SDK, legacy DDE and COM automation, file-based integration, and workflow tiles - with working code and clinical workflow patterns.

18 min readRead article →
Spectroscopy Startup Challenges: 10 Gaps from Research to Clinic
Strategy

Spectroscopy Startup Challenges: 10 Gaps from Research to Clinic

Every spectroscopy startup faces ten gaps between a working prototype and a clinical product. Here is the regulatory, integration, and commercial roadmap.

21 min readRead article →
Spectroscopy Software Comparison: A Clinical Buyer's Checklist
Strategy

Spectroscopy Software Comparison: A Clinical Buyer's Checklist

Evaluate spectroscopy software with this clinical checklist: instrument integration, HL7/FHIR interoperability, ML support, compliance, and vendor red flags.

20 min readRead article →
Raman Clinical Integration: Horiba, Renishaw, and Handheld APIs
Raman

Raman Clinical Integration: Horiba, Renishaw, and Handheld APIs

Raman clinical integration across Horiba, Renishaw, and handheld devices - vendor APIs, data formats, fluorescence handling, and point-of-care challenges.

14 min readRead article →
21 CFR Part 11 for Spectroscopy: Audit Trails and Compliance
Regulatory

21 CFR Part 11 for Spectroscopy: Audit Trails and Compliance

21 CFR Part 11 compliance for spectroscopy software: audit trail requirements, electronic signatures, what FDA inspectors check, and a 15-item checklist.

15 min readRead article →
HL7v2 Spectroscopy Integration: Generating ORU^R01 Messages
Integration

HL7v2 Spectroscopy Integration: Generating ORU^R01 Messages

HL7 integration for spectroscopy instruments: generate ORU^R01 messages from spectral classification results that Epic, Cerner, and other EHRs accept.

11 min readRead article →
FTIR Python Automation: A Practical Measurement Tutorial
FTIR

FTIR Python Automation: A Practical Measurement Tutorial

FTIR Python automation from spectral file parsing to measurement triggering via the OPUS DDE interface - a complete hands-on guide for Bruker instruments.

7 min readRead article →
Build vs Buy Spectroscopy Software: Cost and Timeline Analysis
Strategy

Build vs Buy Spectroscopy Software: Cost and Timeline Analysis

Building spectroscopy software in-house costs $300-600K and 12+ months. A platform approach deploys in 8 weeks. Full cost breakdown and break-even analysis.

15 min readRead article →
SaMD Classification for Spectroscopy: FDA Software Regulation
Regulatory

SaMD Classification for Spectroscopy: FDA Software Regulation

SaMD classification determines your regulatory path for spectroscopy diagnostics. Where the ML model runs sets your FDA burden - here is the framework.

15 min readRead article →
Spectral Classification with ML: Building Clinical AI Pipelines
AI/ML

Spectral Classification with ML: Building Clinical AI Pipelines

Build a complete spectral classification pipeline for clinical diagnostics — preprocessing, feature extraction, model selection, validation, and deployment.

12 min readRead article →
Bruker OPUS Python Integration: Guide to All 5 Interfaces
FTIR

Bruker OPUS Python Integration: Guide to All 5 Interfaces

Bruker OPUS Python integration covering all five programmatic interfaces - DDE, Named Pipes, HTTP, OPC, and COM/ActiveX - with working code and examples.

11 min readRead article →
Building Clinical Workflow Software for Spectroscopy-Based Diagnostics
Architecture

Building Clinical Workflow Software for Spectroscopy-Based Diagnostics

Architecture decisions for wrapping lab instruments in clinician-facing UIs - from patient context and instrument control to ML classification and HL7 output.

14 min readRead article →
FTIR vs Raman vs NIR: Choosing a Point-of-Care Modality
Comparison

FTIR vs Raman vs NIR: Choosing a Point-of-Care Modality

FTIR vs Raman vs NIR compared for point-of-care diagnostics — acquisition speed, instrument APIs, preprocessing, ML models, and total deployment cost.

15 min readRead article →

Spectroscopy diagnostics in 5 minutes. Monthly.

FDA submissions, new research, instrument vendor news, and one technical tip. For lab directors and diagnostic startup founders.