
medical-device

Nervonik, Inc., a medical technology company developing a next-generation peripheral nerve stimulation platform for chronic pain, today announced it is expanding its leadership team with the addition of several experienced medical device and neuromodulation leaders - Rob DiTota, Dan Brounstein, and Patrick Martin - as the company moves toward its planned 510(k) submission and commercial launch.

Charles R. Goulding and Preeti Sulibhavi discuss MakerStage’s push to streamline medical-device-aware supplier routing across a global network, connecting supply with demand. The post Solving the Procurement Puzzle: MakerStage’s Vision for Smarter, Compliant Medical Manufacturing appeared on Fabbaloo .

Fundraising: Crucial for Translational Researchers Medical device development is expensive, time-consuming, and uncertain—and virtually none of it happens without outside capital. For translational researchers making the transition from lab to startup, fundraising is often unfamiliar territory, requiring a different kind of persuasion than a grant application or a journal submission. Investors ar…
Medical device manufacturers who want to sell their devices on the EU market must draft and maintain a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745). The clinical evaluation report is a critical step for CE marking of medical devices and during the lifetime of the device - it must be updated continuously. While the EU MDR does describe clinical e…
Laurent Leksell, PhD, MBA, founded Elekta AB to commercialize his and his father’s – Lars Leksell’s – inventions in stereotactic surgery and radiosurgery.
Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates independently to perform medical functions from diagnostics, patient monitoring, and image processors to artificial intelligence (AI) and deep learning neur…
Incubators and accelerators are programs designed to help start-up companies gain traction. Incubators generally focus on very early companies or entrepreneurs at the idea stage, while accelerators are designed for more advanced companies with products in preclinical or clinical trials.  The programs come in many different flavors. Incubator and accelerator programs can be non-profit or ...
Using CFD to Evaluate Medication Delivery TotalSim US Evaluates Medical Device The Situation: Patients need to be put on a ventilator for many reasons including while under general anesthesia during surgery or respiratory distress. Some patients will have problems that result in constriction of bronchi and bronchioles which needs to be treated by administering bronchodilators such as Albuterol an…
US regulators are teaming up with medical device companies and non-profit organizations in an effort to advance better and safer tools for evaluating the safety, quality and efficacy of medical technologies. Read more Continue reading →




