As we navigate the complexities of cancer care, there’s a shared commitment to driving change and ensuring equitable access to life-saving treatments. This year’s World Cancer Day theme, “Close the Care Gap”, emphasises the importance of prioritising cancer care and fostering innovative strategies to address healthcare disparities.
In this blog, we’re shining a spotlight on two pioneering enterprises dedicated to closing the care gap through their innovative medical device solutions. Join us as we explore their advancements in early cancer detection, prevention, and diagnosis, and continue the conversation sparked by World Cancer Day.
MiWEndo Solutions is in revolutionary developments of an Electromagnetic Endoscopy accessory to automatise polyp
detection. This medical device integrates microwave technology
with colonoscopy in order to improve the prevention, diagnosis and knowledge of colorectal cancer. Their technology automates the detection of polyps by emitting an alarm when a polyp is detected, creating 360º views and provides a quantitative classification of the tissue.
Why their innovation matters?
As MiWEndo Solutions pioneers electromagnetic technology to automate polyp detection, it yields more effective results by enhancing vision and offering more accurate characterisations.
Their innovative accessory is not only safe, producing no radiation, but it is also designed to seamlessly attach to the tip of a conventional colonoscope. This design ensures the accessory’s low cost, eliminating the need for practices to modify existing clinical procedures. This not only maintains current practices but also provides significant accessibility values.
How have Rephine helped MiWEndo Solutions with their QA journey?
Tailored a course on IEC 62304 aimed to align MiWEndo’s software development with international standards, reinforcing the robustness of their quality assurance processes
Strategic audits to identify the current compliance level and gaps, enabling focused efforts to ensure MiWEndo has the necessary evidence and documentation for CE marking qualification
Frontwave Imaging provides an accessible supercomputing Software as a Medical Device (SaMD) that creates high-resolution 3D ultrasound images, enhancing breast cancer diagnostics. They also provide seamless data transfer to Cloud services, incorporating image reconstruction, and enabling analysis through a user-friendly interface.
Despite a decline in mortality rates,
the yearly fatalities continue to rise,
driven by the aging population
Why their innovation matters?
Frontwave Imaging’s HPC-driven technology ensures accessible Cloud software for early detection and unrestricted tumour progression monitoring. Amid the high breast cancer statistics. by utilising their ultrasound software, it offers safer, cost-effective, and more accurate diagnostics by eliminating radiation risks in mammography, and implementing continuous image reconstruction improvements over time.
As this groundbreaking technology prioritises patient safety, it has a higher sensitivity to all breast types, and high-resolution imaging comparable to MRI, enhancing diagnostic precision.
How have Rephine helped Frontwave Imaging with their QA journey?
Focused on establishing the right QA environment, with appropriate structures and processes to maintain high-quality standards in their operations
Continue conducting the functional verification of their software, with ongoing processes for the Technical File required for CE marking
Celebrating MiWEndo Solutions and Frontwave Imaging’s pioneering technologies, their commitment will continue to improve many lives through collaborative, safe, and innovative approaches.
Beyond technological advancements, their dedication to cutting-edge, affordable, and accessible solutions, emphasises the value of prioritising patient safety. Their innovation plays a pivotal role in advancing cancer diagnosis and prevention, working towards a more equitable healthcare landscape and ultimately assisting in closing the care gap.
Rephine has extensive experience of supporting SMEs breaking into the cancer treatment market
From acting as your Person Responsible for Regulatory Compliance (PRRC) to implementing cloud systems, you can find more about our Medical Device services, and contact our experts by visiting our Medical Devices page.
