FDA timelines are getting longer. That changes how medtech startups should build. For medtech founders, FDA clearance has always mattered. But the latest reporting on device review timelines reinforces something we are feeling across the industry: getting to market is taking longer, even as approvals continue to rise. That matters because regulatory timing is no longer just a compliance issue — it is a business…
If you are building a medtech company, one of the first big questions you may have is: what FDA pathway applies to my medical device? The applicable regulatory pathway may affect your timeline, evidence plan, budget and go-to-market strategy, so understanding it early can save real time and money. The good news is that most…
FDA and CMS just launched two new programs — RAPID and TEMPO — to help innovative medical devices reach patients faster. For startups, this could mean shorter gaps between FDA approval and Medicare coverage, or better ways to build real-world evidence. The catch? These programs only work if you understand them early and plan accordingly….
The regulatory environment for medical devices is becoming more constrained, and that is starting to affect how medtech startups interact with FDA. As workloads continue to rise inside CDRH, the practical result for sponsors is not just slower response times — it is a shift in the nature of engagement itself. More questions are being…
The regulatory ground under wearable and AI-enabled devices is shifting—and for once, it’s in a direction many innovators will welcome. In early 2026, FDA issued updated guidance on low‑risk wellness products (including many wearables) and on clinical decision support (CDS) software, easing premarket requirements for certain functions while clarifying where full device regulation still applies….
For MedTech startups, an FDA inspection can be one of the most defining moments in the journey to market. It’s not just about passing an audit—it’s about demonstrating that your organization has established a robust Quality Management System (QMS) and consistently uses its processes to build a device that is safe and effective. For early-stage…
Because Santa isn’t the only one checking twice… your regulatory team is too. The holiday season has a way of making all of us reflect—on what we’ve built, what we’ve learned, and what we might need to tighten up going into the new year. For medtech startups, it’s also the perfect moment to pause and…
What Santa (and the FDA) Want You to Know This Holiday Season The holidays are a time for reflection—on what we’ve built, what we’ve neglected, and what we promise to do better in the year ahead. For MedTech startups, this season is a perfect moment to take a lighthearted (but honest) look at your Quality…
Navigating the New Regulatory Reality with Avio Medtech When the U.S. FDA becomes the headline instead of the gatekeeper, you know the medtech world is in for a ride .At this year’s MD&M Midwest Conference, the panel “FDA, WTF, Now What?”—moderated by Frank Jaskulke, Vice President of Business Development and Sales at Avio Medtech, and…
Key Takeaway While FDA’s Breakthrough Device Designation program has grown to nearly 1,200 designations as of 2025, significant concerns about its value proposition have emerged, particularly considering recent FDA staffing cuts. For many companies, especially those pursuing 510(k) clearance, the program may no longer deliver meaningful benefits and could potentially increase regulatory burden. Current State…