In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests.
In September, Med Device Monday featured cool medical devices that have not yet been FDA approved. I want to squeeze in one last one as we move into October!
I've written before about why I do what I do and why it's important to me to get innovative devices like these to market. Products like this are integral to my work, but moreover, they are interesting, innovative, and fill a need. Join me in exploring some exciting new devices that I hope to see on the market soon. Feel free to share more innovative devices in the comments!
Briteseed's product is SafeSnips, a device that helps surgeons detect blood vessels before they can accidentally be cut.
In laproscopic surgeries, tools are all the surgeon has. They aren't able to use their tactile senses to detect a blood vessel, and bleeding is a real concern. While estimates are that only 2% of surgical patients have a blood vessel cut accidentally, the founders of Briteseed say that 20% of those who do will die.
The SafeSnips Twitter bio says its "technology adds real-time vessel detection to existing surgical tools to improve patients' lives and reduce hospital costs". The Briteseed/SafeSnips website elaborates on the need for this device, saying "Surgeries are inherently dangerous procedures. Regardless of the expertise of the surgeon, a patient who undergoes a surgical procedure is subject to unintended complications that could result in a long recovery time, serious injury, or worse. Despite improvements in surgical technique, unintended cuts followed by bleeding remains a significant risk. In the United States alone, up to 32% of all unintended bleeding incidents are fatal. Patients who do survive face long-term complications that include lengthy hospital stays and decreased quality of life. SafeSnips addresses the need for improved patient safety and better surgical outcomes by working to stop accidental cuts before they happen."
So what exactly does SafeSnips do to help? SafeSnips is infrared technology that's intended to be added to surgical tools, and uses infrared technology to detect hemoglobin.
This article from Techli sums it up nicely: "How do near-infrared rays come into play? The key lies in hemoglobin, an iron-containing and oxygen-transporting protein in our red blood cells. Incidentally, according to Fehrenbacher, “this hemoglobin absorbs near-infrared rays more than surrounding tissue. Using a novel algorithm, this absorption difference can be used to provide surgeons with the location of blood vessels while using surgical cutting instruments.”
And because hemoglobin flows freely throughout the blood vessel, detecting its presence allows for diameter and orientation measurements of the blood vessels, too, as well as how fast the blood flows. According to the SafeSnips website, the detection system is fully automatic and continous, thus adding to the surgeon’s (and patient’s) peace of mind."
MedTech Innovator has another video and more information here.