Biocompatibility Testing: The Invisible Safety Layer Behind Every Stent Before a coronary stent ever reaches a cath lab, it has to pass one of the most rigorous testing regimes in medical device development: biocompatibility testing under
READ MOREMedical Device Package Validation | InSitu Technologies Sterile Barrier Systems How Medical Device Packaging Is Validated A closer look at the testing behind every sterile package and why package validation is essential to protecting patients. Most
READ MOREPost-Market Surveillance SIRO 2025 Annual Review A review of safety, quality, manufacturing progress, and customer feedback. InSitu Technologies completed its 2025 post-market surveillance review for the SIRO Drug-Eluting Coronary Stent. The findings confirmed continued product safety,
READ MOREBehind the Scenes: Accelerated Aging for Packaging Validation A closer look at how controlled temperature and humidity testing helps us evaluate packaging performance over time. Temperature and humidity chamber operating at controlled conditions during an accelerated
READ MOREBehind the Scenes: How InSitu Technologies Monitors Device Safety After Products Reach Patients At InSitu Technologies, our responsibility doesn’t end when a device leaves our facility. In many ways, some of the most important work begins
READ MOREIndustry Update FDA Expands Use of Real-World Evidence in Medical Device Applications The U.S. Food and Drug Administration (FDA) recently announced that it will begin accepting certain forms of de-identified real-world evidence in select medical device
READ MOREProduct Spotlight Introducing the AaRiss™ Drug-Coated Balloon Catheter As interventional cardiology continues to evolve, physicians are increasingly seeking treatment options that effectively address vessel narrowing while minimizing the amount of permanent material left behind in the
READ MOREIndustry News Interventional Cardiology Market Continues Strong Growth A new market report released by Emergen Research points to continued growth in the global interventional cardiology devices market, driven by rising demand for catheter-based cardiovascular procedures. According
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