medical-devices
If you’ve worked in medical devices for a while, the term Device Master Record or DMR probably feels like muscle memory. It’s been part of the regulatory vocabulary for decades, especially if you’ve worked with U.S. Food and Drug Administration (FDA) requirements.
A vital tool for healthcare practitioners, electroencephalography (EEG) systems measure electrical activity in the brain through electrodes placed on the scalp, but getting reliable readings can be surprisingly difficult. Hair interferes with contact between the electrodes and skin, and the gels used to improve those connections often dry out over time, weakening signal quality. Researchers at Pe…
In the medical devices industry, “ design transfer ” refers to the process of transitioning a medical device from development to large-scale manufacturing. For manufacturers, particularly personnel in the quality, R&D, and manufacturing functions, a working knowledge of design transfer and compliance with requirements is essential. In this post, we’ll explain why design transfer is important, how…
In my experience as a quality professional, I have found that a CAPA medical device system is the most revealing part of a company's internal structure. I once worked with a team that had nearly 40 open files, some dating back eighteen months, because they treated the process as a secondary administrative task rather than a priority.
Medical devices are becoming smaller, lighter and more portable. From handheld diagnostic tools to wearable infusion pumps and compact surgical instruments, reduced size is now a defining feature of many new Medtech products.
Scientists at Penn State have developed soft, stretchy electronic implants that could help treat people with dangerous high blood pressure that does not respond to medication. The new devices gently stimulate a major artery in the neck using tiny electrical signals. In animal tests, the implants lowered blood pressure while causing much less tissue damage […] The post This stretchy implant could …
Researchers at Penn State have developed a new class of 3D-printed bioelectronics made of soft, stretchy materials, as well as an adhesive component that helps the device painlessly stick to biological tissue. The team reported that their new design, which they call CaroFlex and tested in a rodent model, relieved hypertension while causing much less damage to surrounding tissue.
Bench to Bedside APEX is a global competition for student-founded companies developing medical devices, diagnostics, and health technologies. Teams present their business plans and innovations to a panel of judges representing clinical, engineering, and investment expertise. The competition emphasizes device-focused innovation with the potential to improve patient outcomes, streamline care, and a…
The medical device giant Medtronic won approval for its Altaviva implant, a tibial neurostimulator, in September. The device, roughly half the length of a stick of chewing gum (43.7 × 15.7 × 4.5 mm, 7.5 g), recently won a 2026 Edison Award for health innovation. Most recently, Medtronic recently enrolled its first patient in the… The post Medtronic launches five-year post-approval study for Altav…
Bedfont® Scientific Limited, an innovative MedTech company that specialises in designing and manufacturing medical breath analysis devices, is thrilled to have been shortlisted in the Export Achievement category at the Science and Engineering Health Technologies Alliance (SEHTA) Healthcare Business Awards 2026.
Developing AI-guided, patient-operated home ultrasound probes that can produce a reliable medical image. The post Beyond the Clinic: A Blueprint For Developing Reliable, Edge AI-Enabled Medical Devices appeared first on Semiconductor Engineering .

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 …
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