Synaptic Digest: When Control Algorithms Fail, Patients Are at Risk Today's issue digs into an Olympus insufflator recall caused by a software algorithm's overpressure failure, a new FDA draft guidance that's raising t... SYNAPTIC DIGEST TUESDAY, JANUARY 27, 2026 | 15 MIN READ At a Glance: Today's issue digs into an Olympus insufflator recall caused by a software algorithm's overpressure failure, a new FDA draft guidance that's raising the bar for cuffless blood pressure monitors, and...
about 1 month ago • 12 min read
Synaptic Digest: A Stent Deployment Failure, FDA's New Cyber Mandate, and Lessons from WHOOP Today's issue digs into a critical stent deployment failure leading to a major recall, breaks down the FDA's new non-negotiable cybersecurity rules th... SYNAPTIC DIGEST THURSDAY, JANUARY 22, 2026 | 15 MIN READ At a Glance: Today's issue digs into a critical stent deployment failure leading to a major recall, breaks down the FDA's new non-negotiable cybersecurity rules that can get your submission...
about 1 month ago • 12 min read
FDA's Big ISO 13485 Shift, Mexico's New Digital Health Rules, and Burr-Free Micro-Metals Today's issue breaks down the FDA's monumental shift to ISO 13485 and what it means for your QMS, then explores Mexico's new digital health and techno... SYNAPTIC DIGEST TUESDAY, JANUARY 20, 2026 | 12 MIN READ At a Glance: Today's issue breaks down the FDA's monumental shift to ISO 13485 and what it means for your QMS, then explores Mexico's new digital health and technovigilance regulations. We also look...
about 1 month ago • 10 min read
When Material Science Fails: Detaching Needles, Cracking Tubes, and 10x Dosage Errors Today's issue digs into a catastrophic needle failure where heat shrink degradation led to a patient death, explores how anesthesia tubes can crack fr... SYNAPTIC DIGEST SUNDAY, JANUARY 18, 2026 | 14 MIN READ At a Glance: Today's issue digs into a catastrophic needle failure where heat shrink degradation led to a patient death, explores how anesthesia tubes can crack from material instability, and analyzes...
about 1 month ago • 13 min read
MDUFA VI Heats Up, Steerable Catheters, and the Next Wave of PFA Today's issue dives into the MDUFA negotiations and what FDA budget cuts could mean for your next submission. We also explore the complex engineering ... SYNAPTIC DIGEST THURSDAY, JANUARY 15, 2026 | 12 MIN READ At a Glance: Today's issue dives into the MDUFA negotiations and what FDA budget cuts could mean for your next submission. We also explore the complex engineering behind newly cleared steerable microcatheters and focal...
about 2 months ago • 10 min read
FDA Rewrites the Rules on Wellness Devices and CDS Software Today's issue dives into the FDA's game changing new guidance on wellness and clinical decision support software, explaining how the line between a re... SYNAPTIC DIGEST TUESDAY, JANUARY 13, 2026 | 15 MIN READ At a Glance: Today's issue dives into the FDA's game changing new guidance on wellness and clinical decision support software, explaining how the line between a regulated device and an app has shifted. We also cover Medtronic's...
about 2 months ago • 13 min read
A Packaging Failure, FDA's New AI Rules, and When Power Backups Fail Today's issue digs into a critical organ transport packaging failure, unpacks the FDA's game changing new rules for wellness apps and AI, and analyzes... SYNAPTIC DIGEST SUNDAY, JANUARY 11, 2026 | 16 MIN READ At a Glance: Today's issue digs into a critical organ transport packaging failure, unpacks the FDA's game changing new rules for wellness apps and AI, and analyzes two classic hardware failure modes in infusion sets and...
about 2 months ago • 13 min read
FDA Loosens Rules, J&J Hides a Robot, and Your Earbuds Get Brainwaves Today's issue unpacks the FDA's surprising new stance on wellness and clinical decision support software, which could change your entire product roadm... SYNAPTIC DIGEST THURSDAY, JANUARY 8, 2026 | 12 MIN READ At a Glance: Today's issue unpacks the FDA's surprising new stance on wellness and clinical decision support software, which could change your entire product roadmap. We also explore the wild mechanical engineering...
about 2 months ago • 10 min read
SYNAPTIC DIGEST TUESDAY, JANUARY 6, 2026 | 16 MIN READ Today's issue analyzes a critical infusion pump software recall that highlights configuration control risks, explores a catheter failure rooted in material science, and examines the regulatory landscape for new AI driven diagnostic tools and novel biomaterials. Recall Analysis 📖 5 min read The Wrong Brain: When Software and Hardware Do Not Match Baxter has issued a Class I recall for its Sigma Spectrum infusion pumps after discovering a...
about 2 months ago • 14 min read