📋 FDA 510(k)

Medical Device Approval, Regulatory Compliance, Predicate Devices, Clinical Validation

Risk of dementia following gabapentin prescription
rapm.bmj.com·1d·
Discuss: Hacker News
🩺medical devices
Stop monitoring systems; start monitoring outcomes
intercom.com·1d·
Discuss: Hacker News
⌚wearables
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
statnews.com·2d·
Discuss: Hacker News
🩺medical devices
The Fourth Wave: How Speedballing Is Creating a New Kind of Drug Crisis
gizmodo.com·9h·
Discuss: Hacker News
🩺medical devices
Computational understanding of Li-ion batteries (2016)
nature.com·1h·
Discuss: Hacker News
🩺medical devices
Data mining uncovers treasure-trove of previously 'untouchable' proteins for drug development
phys.org·11h·
Discuss: Hacker News
🧩RBGASM
Eye blink frequency variation and executive function enhancement from exercise
jphysiolanthropol.biomedcentral.com·5h·
Discuss: Hacker News
😴sleep apnea
Mcbot McHacked
captaincompliance.com·2h·
Discuss: Hacker News
⌚wearables
A Refreshing SQL Injection Discovery in Z-Push
xbow.com·2d·
Discuss: Hacker News
🦀Rust
Light exposure at night predicts incidence of cardiovascular diseases
medrxiv.org·18m·
Discuss: Hacker News
⌚wearables
Fecal medicines used in traditional medical system of China
pmc.ncbi.nlm.nih.gov·5h·
Discuss: Hacker News
📊HL7
Reverse Engineering the Firmware Loader for an X-Rite Spectrophotometer
adam.zeloof.xyz·1d·
Discuss: Hacker News
🩺medical devices
Exclusive: NIH suspends dozens of pathogen studies over ‘gain-of-function’ concerns
science.org·1d·
Discuss: Hacker News
🩺medical devices
A model for IV&V that's useful
waldo.jaquith.org·2d·
Discuss: Hacker News
🩺medical devices
Is Pain "All in Your Mind"? Examining the General Public's Views of Pain (2021)
link.springer.com·5h·
Discuss: Hacker News
🩺medical devices
The Potential Link Between an FAA Bulletin and the Air India Disaster
aviacionline.com·8h·
Discuss: Hacker News
😴sleep apnea
Using AMD MI300X for High-Throughput, Low-Cost LLM Inference
herdora.com·2h·
Discuss: Hacker News
🦀Rust
RFC 9309 – Robots Exclusion Protocol
datatracker.ietf.org·2d·
Discuss: Hacker News
🐍Python
Show HN: BinaryRPC – Lightweight WebSocket-based RPC framework in modern C++
github.com·6h·
Discuss: Hacker News
🦀Rust
The Bytebot Core – From Linux Container to Agent Control Surface
bytebot.ai·6h·
Discuss: Hacker News
🦀Rust