FastWave Medical has completed the first human procedures with its Sola coronary laser intravascular lithotripsy system. The company said that these initial procedures marked the start of its multi-center feasibility study evaluating the platform’s safety and performance. [Scott Nelson, FastWave Medical’s co-founder and CEO, will participate in a panel about IVL’s promise at DeviceTalks Minnesota, […]
FastWave Medical
Getting your medtech to market: Here’s what really works
The medtech market closed 2024 just shy of $400 billion and could exceed $500 billion by 2029. But growth in the sector hinges on more than novelty alone — adoption is what turns a startup into an actual business. Even the most advanced technology can fall short if it doesn’t fit into real-world clinical workflows. […]
FastWave Medical earns nod to begin IVL feasibility study
FastWave Medical announced today that it received Institutional Review Board (IRB) approval to begin a coronary feasibility study. The study utilizes Sola, the company’s novel laser intravascular lithotripsy (IVL) system. FastWave partnered with Clinical Accelerator to secure the approval, which paves the way for its planned U.S. pivotal trial. Minnapolis-based FastWave designed Sola to treat […]
How to design medtech clinical trials that deliver
Transparent, well-designed clinical trials are a must. Here’s advice on how to get there. Scott Nelson, co-founder and CEO of FastWave Medical Dozens of medical devices annually make it onto the FDA’s list of the newest approved medtech. Yet, alongside this progress, the agency faces a stark reality: over the last decade, faulty devices have been […]
How you can achieve product-market fit in medtech
In medtech, product-market fit can be key to keeping you out of the graveyard of once-promising startups. Scott Nelson, co-founder and CEO of FastWave Medical It’s incredibly rewarding to build in the medtech space, but some data suggests the average medical device requires $31 million to develop, with nearly three-quarters of that budget dedicated to […]
FastWave raises $19M for IVL platform
FastWave Medical announced today that it closed an oversubscribed funding round worth proceeds of $19 million. Minneapolis-based FastWave, which develops intravascular lithotripsy (IVL) technologies, said the funding brings it to more than $40 million raised in total. Epic Venture Partners led the round, which had participation from M&L Healthcare Investments and the company’s existing investors. […]
FastWave Medical secures sixth patent for IVL portfolio
FastWave Medical today announced the sixth U.S. utility patent for its laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease. This is the fourth patent that Minneapolis-based FastWave Medical has secured from the U.S. Patent and Trademark Office this year. The company announced previous patents in May and April. IVL is a hot space, with […]
FastWave reports positive 30-day results in first-in-human IVL study
FastWave Medical today announced successful 30-day results from the first-in-human study of its intravascular lithotripsy (IVL) technology. Minneapolis-based FastWave develops laser-based IVL technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output. The system helps to navigate complex arterial anatomy through a high-performing catheter. IVL is a […]
FastWave Medical picks up another IVL patent
FastWave Medical announced that the United States Patent and Trademark Office (USPTO) issued it another intravascular lithotripsy (IVL) utility patent. This marks the fifth IVL utility patent in the past three years for the company, which earned one last month for its novel next-generation laser-IVL technology. Minneapolis-based FastWave develops laser-based IVL technology for treating calcific artery […]
FastWave Medical wins patent for laser-IVL tech
FastWave Medical announced today that it received a fourth utility patent to strengthen the IP foundation of its IVL platform. Minneapolis-based FastWave develops laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output to navigate complex arterial anatomy through a high-performing catheter. FastWave’s […]
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures […]
