Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach.
CathWorks FFRangio System employs drug-free, wire-free technology for comprehensive physiological assessment.
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?
MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors. Real success comes from choosing high-quality science over quick shortcuts, as being thorough is the only way to build lasting trust and reach the market.
Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.
To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.
CE Marked and 510(k) pending, Philips says Rembra’s advanced image reconstruction technology delivers up to 106 images per second and a high throughput of up to 270 patients per day [2] to support faster diagnosis by making scans available in near-real time.
The Revello™ Vascular Covered Stent is designed to combine the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries. Iliac artery disease is a key component in lower‑extremity peripheral artery disease (PAD), and according to a company Press Release, Revello™ can help reduce a substantial disability burden across the EU’s aging population.
What is driving the need for increased transparency across the MedTech organization relative to product innovation, development and commercialization?
New patient-specific solution expands Catalyst’s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy .