Beyond addressing an unmet medical need, diagnostics device makers serving the home point-of-care (POC) market must satisfy both the care provider and the patient if a product is to succeed. Add to that the challenge of keeping pace with the evolution of telehealth and mobile health platforms, and the uncertainty of new technology — specifically, that it doesn’t always deliver on its promise of a trouble-free solution.
Despite global medtech giants’ domination of India’s medical device industry and unfavorable domestic regulations, local startups hope to make lifesaving medical technology more accessible in a country where high-quality, affordable healthcare is scarce. Their products and ideas stand ready to impact markets across Africa, low-income countries in South America, Asia, and even Eastern Europe.
Medtech entrepreneurs need to think like their investors and structure their operations accordingly. Excessive spending without achieving the critical milestones will not be tolerated; nor will an overly restricted cash burn that leaves a project limping forward.
Historically, startups haven't gone through the entire product development process. They’ve done the heavy lifting with innovation and engineering, but are at a loss when it comes to navigating regulatory approval and figuring out how to successfully (and compliantly) commercialize. This is where value can be lost.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
Baxter has signed a four-year agreement with Satellite Healthcare, a non-profit organization that provides kidney dialysis and other related services. Baxter’s latest technology in peritoneal dialysis, hemodialysis, and continuous renal replacement therapy will be incorporated into Satellite Healthcare’s service offerings for over 7,000 patients in the U.S.
Medtronic's first quarter net income rose due to lower costs and tax payments, enough to offset a slight decrease in sales partly attributed to a down product cycle in the United States. Company executives, however, foresee a rebound in upcoming quarters as new products gain regulatory approval. Also, new acquisition HeartWare is expected to establish itself as a key performance driver going forward.
Scientists from Carnegie Mellon University (CMU) have developed a battery made from melanin, a naturally occurring compound in human skin, eyes and hair, which they say can power a 5 milliWatt device for 18 hours.
The U.S. Food and Drug Administration (FDA) has issued final guidance on factors in making benefit-risk determinations for premarket approval (PMA) and de novo classifications, as well as related final guidance on patient preference information to help FDA evaluate the benefit-risk profile of certain devices.
Patient organizations and industry groups want the U.S. Food and Drug Administration (FDA) to clarify salient points in its draft guidance on how manufacturers should share patient-specific data with patients.
Bio2 Medical is pleased to announce the Angel® Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA).
Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride as a platform for biomedical applications, is pleased to announce the U.S. Food and Drug Administration (FDA) clearance of expanded Valeo® II Lateral Lumbar sizes.
The FDA has for the first time cleared a computerized diagnostic device designed specifically to evaluate a patient’s cognitive function immediately following a head injury and a suspected traumatic brain injury (TBI), otherwise known as concussion. While the Immediate Post-Concussion Assessment and Cognitive Testing (imPACT) device cannot conclusively diagnose TBI on its own, or direct a course of treatment, the tool offers point-of-care quantitative evaluation to assist trained healthcare providers in making treatment decisions.