medical-devices

Researchers from USC and Caltech aim to develop a tiny sensor and drug delivery system, implanted near the eye, with dry eye disease as its first target. The post USC-led team receives funding to build next-generation medical device that uses tears to monitor health appeared first on USC .

Nervonik, Inc., a clinical-stage medical device company developing next-generation peripheral nerve stimulation (PNS) technologies, today announced the closing of an oversubscribed $52.5 million Series B financing.

the Ontogen Medtech Biomedical Innovation Scholarship is intended to support promising biomedical engineering students who are passionate about building real-world medical devices and contributing to patient impact—especially students pursuing hands-on product development, manufacturing, and commercialization pathways. Applications due August 31

Cala(r), the bioelectronic medicine leader, today announced U.S. Food and Drug Administration (FDA) clearance of the Cala kIQ(r) Plus system, the next-generation of its wearable neurostimulation device for action hand tremor in essential tremor (ET) and Parkinson's disease (PD).

When a ureteral stent fails, pressure can quietly build inside the kidney long before clinical symptoms. A new device called UroSleeve aims to enable earlier detection by turning a standard stent into a passive wireless pressure monitor via a modular sleeve. Designed as a modular sleeve rather than a redesigned implant, it fits around conventional stents and tracks intrarenal pressure through res…

A team of engineers, chemists and physicians at UNC-Chapel Hill is developing a breakthrough membrane technology that could shrink today’s refrigerator-sized dialysis machines into a wearable, smartphone-sized artificial kidney—potentially transforming care for hundreds of millions of patients worldwide. The post A Smartphone Moment for Kidney Dialysis appeared first on Department of Chemistry .

In the medical device industry, there are tons of abbreviations. And as a medical device professional in the US working with Quality Management Systems Regulations (QMSR), or 21 CFR Part 820 as it’s technically known, you can easily get lost in this acronym ocean! Until recently, the most important (and most confusing) abbreviations to understand were: DHF, DMR, DHR. These three abbreviations hav…

Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in any indicated situation. Potentially the most daunting task of medical device development is the regulatory aspect. Ensuring regulatory compliance can …

If you work in medical devices in the EU, the question is no longer what EUDAMED is, but whether your data and ownership model will survive mandatory use.

New technology could make diabetes management more accessible to those who need it most. The post Microneedles enable 98% smaller, cheaper artificial pancreas appeared first on Advanced Science News .

Developing and manufacturing a stable and safe medical device is difficult for even the most experienced manufacturers. How can you ensure you manufacture highly predictable medical devices that offer consistent performance with minimal variation? The answer is process validation. Process validation is the framework around your medical device manufacturing process that ensures your device is inst…

Many medtech teams are laser-focused on building the perfect product—sleek prototypes, groundbreaking technology, elegant user interfaces. But even the most brilliant design can stall if compliance is left as an afterthought. Whether you're preparing for CE marking, FDA clearance, or MDR compliance, the demands on your quality and product teams are rising. But many still rely on spreadsheets, dis…

Risk management is a vital part of medical device development and lifecycle processes. Most regulatory agencies, including central authorities such as the European Union and the Food and Drug Administration (FDA), include risk-based methods in their internal processes for medical device and manufacturer evaluations. They also require medical device manufacturers to apply risk management processes…

EMEA Office Louizalaan 489 1050 Brussels Belgium Amnovis is an additive manufacturing production and engineering company, launched in 2020, that embodies a real sense of entrepreneurship. What sets this young startup apart is their focus on innovation using the latest cutting-edge tech in an extremely regulated industry; Medical Devices. Amnovis is a contract manufacturer of high end quality crit…

EMEA Office Louizalaan 489 1050 Brussels Belgium Automate your most critical quality workflows with a compliant and structured QMS software for medical devices that's equipped with document control, training, and event management. Create up-to-date, audit-ready reports instantly for internal reviews, external partners, or regulatory submissions straight from your project workspace. View, add, upd…

Profound has two therapeutic ultrasound devices on the market – the TULSA-PRO and the Sonalleve.

FUSMobile has announced that its Neurolyser XR system has been granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain.

Publication Date 11-3-2025 Abstract As wearable and implantable medical devices become integral to remote patient monitoring and precision medicine, the associated cybersecurity and privacy risks demand urgent attention. These devices are increasingly targeted by cyberattacks, potentially endangering patient safety and data integrity. To address this, we developed an experiential learning course …

A groundbreaking implant is helping blind patients read again after years of darkness. Backed by a major European clinical trial, this tiny chip is rewriting what's possible for millions living with vision loss.

EMEA Office Louizalaan 489 1050 Brussels Belgium In this forward-thinking webinar, Robin Kerbel and Carolyn Whiting from Six Degrees Medical explore how the metaverse is creating new possibilities for innovation in pharma, biotech, and medical devices. You’ll learn: How the metaverse is reshaping medical education and training Innovative use cases in clinical trial planning and engagement Strateg…