Key Tech co-founder Jenny Regan plans to retire as CEO of the product development firm at the end of August, making way for VP of Strategy Alex Flamm to take her place. Regan has been CEO since she and her co-founders launched the Baltimore firm in 1998. The company said it now has 75 interdisciplinary… […]
Some of the most valuable information in Medical Design & Outsourcing is found in the expert-authored MDO Contributors Network articles covering medtech innovation, design and manufacturing — and it’s all thanks to readers like you. If you’d like to share the latest research, developments or lessons learned from your organization to inspire and empower other… […]
Macro-scale electroporation energy manipulates cellular behavior for effective drug delivery. Saeid Movahed and Daniel Friedrichs, Minnetronix Medical When applied to tissue, electric fields can enable precise and selective ablation effects by manipulating cellular-scale electrical properties. One effect, called electroporation or electropermeabilization, has many therapeutic and diagnostic applications including tumor ablation and intercellular delivery of DNA,… […]
An FDA initiative meant to enhance medical device development is closer than ever to becoming a reality after it survived negotiations with the industry over the Medical Device User Fee Amendments (MDUFA) reauthorization. My last post on MDUFA V touched on the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot laid out in the… […]
Researchers in Switzerland have developed a variable stiffness catheter that can transition between soft and rigid states. A team of researchers from technical university EPFL and ETH Zurich developed the catheter to make minimally invasive surgical interventions like cardiac arrhythmia treatment, simpler and more effective. Catheters are inserted into arteries and navigated to treatment zones… […]
Medtronic (NYSE:MDT) announced that it completed the first patient implants in the Titan 2 pivotal study of its investigational neuromodulation device. Fridley, Minnesota-based Medtronic’s Titan 2 trial will evaluate the safety and efficacy of the company’s implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB). Get the full story at our sister site, MassDevice. […]
Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system. The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit… […]
The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA). If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after… […]
Quantum Surgical announced today that it received FDA 510(k) clearance for its Epione interventional oncology robotics platform. Montpellier, France–based Quantum Surgical designed Epione, a robot-assisted system, to plan, target, deliver and confirm tumor ablation in minimally invasive liver cancer treatment. Get the full story at our sister site, MassDevice. The post FDA clears Quantum Surgical’s robot-assisted […]
Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report. “Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the… […]
Engineers at the University of Leeds have developed a magnetic tentacle robot to pass through the narrow tubes of the lungs. Scientists and engineers at the university made a proof of concept for a robotic device that can reach the smallest bronchial tubes to take tissue samples and deliver cancer therapy. The tentacle robot has… […]
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