4.6 Editorial Material

Regulatory approaches to stimulate innovative renal replacement therapies

Journal

NATURE REVIEWS NEPHROLOGY
Volume 16, Issue 10, Pages 546-547

Publisher

NATURE RESEARCH
DOI: 10.1038/s41581-020-0275-8

Keywords

-

Ask authors/readers for more resources

Regulations for market access and reimbursement of medical devices vary across jurisdictions, complicating the development of innovative technologies for world-wide use; however, several converging regulatory principles are now emerging. Here we discuss approaches by which regulatory and related agencies can promote innovation and boost the effectiveness of regulatory processes to expedite patient access to innovative technologies, including renal replacement therapies.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.6
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

Review Surgery

Optimizing Indocyanine Green Fluorescence Angiography in Reconstructive Flap Surgery: A Systematic Review and Ex Vivo Experiments

Tim Pruimboom, Sander M. J. van Kuijk, Shan S. Qiu, Jacqueline van den Bos, Fokko P. Wieringa, Rene R. W. J. van der Hulst, Rutger M. Schols

SURGICAL INNOVATION (2020)

Editorial Material Engineering, Biomedical

The Kidney Health Initiative innovation roadmap for renal replacement therapies: Building the yellow brick road, while updating the map

Fokko P. Wieringa, Murray Sheldon

ARTIFICIAL ORGANS (2020)

Article Engineering, Biomedical

Probing expert opinions on the future of kidney replacement therapies

Bernardo Pereira Cabral, Joseph Bonventre, Fokko Wieringa, Fabio Batista Mota

Summary: Innovations in kidney replacement therapy are considered to lag behind other medical fields, but the majority of experts anticipate a revolution in kidney replacement therapies in the future, with implantable artificial kidneys and wearable artificial kidneys being the most likely approaches according to the surveyed experts.

ARTIFICIAL ORGANS (2021)

Editorial Material Engineering, Biomedical

Moving ahead on the Kidney Health Initiative innovation roadmap, a transatlantic progress update

Fokko P. Wieringa, Murray Sheldon, Stephen R. Ash, Thomas Groth, Jasper Boomker, Tom Oostrom, Raymond Vanholder

ARTIFICIAL ORGANS (2020)

Article Transplantation

On the potential of wearable bioimpedance for longitudinal fluid monitoring in end-stage kidney disease

Lucas Lindeboom, Seulki Lee, Fokko Wieringa, Willemijn Groenendaal, Carlo Basile, Frank van der Sande, Jeroen Kooman

Summary: Bioimpedance spectroscopy (BIS) is a promising non-invasive technique for fluid monitoring in haemodialysis patients, with the development of wearable devices opening up opportunities for unobtrusive longitudinal fluid status monitoring. This advancement may ultimately lead to improved fluid management, lower mortality rates, and enhanced quality of life for HD patients.

NEPHROLOGY DIALYSIS TRANSPLANTATION (2022)

Book Review Engineering, Biomedical

Father of Artificial Organs - The story of medical pioneer Willem J. Kolff (1911-2009)

Fokko P. Wieringa, Henning Sondergaard, Stephen Ash

ARTIFICIAL ORGANS (2021)

Review Urology & Nephrology

Fighting the unbearable lightness of neglecting kidney health: the decade of the kidney

Raymond Vanholder, Lieven Annemans, Aminu K. Bello, Boris Bikbov, Daniel Gallego, Ron T. Gansevoort, Norbert Lameire, Valerie A. Luyckx, Edita Noruisiene, Tom Oostrom, Christoph Wanner, Fokko Wieringa

Summary: Kidney disease, including both chronic kidney disease and acute kidney injury, imposes a heavy burden on European population, affecting health, quality of life and economy. More research and investment are needed to address this growing issue.

CLINICAL KIDNEY JOURNAL (2021)

Article Transplantation

The European Green Deal and nephrology: a call for action by the European Kidney Health Alliance

Raymond Vanholder, John Agar, Marion Braks, Daniel Gallego, Karin G. F. Gerritsen, Mark Harber, Edita Noruisiene, Jitka Pancirova, Giorgina B. Piccoli, Dimitrios Stamatialis, Fokko Wieringa

Summary: This article emphasizes the mutual impact of climate change on kidney health and kidney care on ecology. It proposes a range of solutions, including measures to reduce water consumption, implement energy-neutral policies, waste triage, and material recycling, to address the ecological burden caused by nephrology care.

NEPHROLOGY DIALYSIS TRANSPLANTATION (2023)

Article Transplantation

The European Kidney Health Alliance (EKHA) and the Decade of the Kidney™

Raymond Vanholder, Paul T. Conway, Daniel Gallego, Eveline Scheres, Fokko Wieringa

Summary: The European Kidney Health Alliance is an advocacy organization that aims to defend the rights of kidney patients and the nephrological community. They have partnered with the American Association of Kidney Patients to launch the Decade of the Kidney initiative, advocating for innovation in kidney care. This article provides an overview of the medical and patient burden of kidney disease, the history and activities of EKHA, and the need for innovation in kidney care.

NEPHROLOGY DIALYSIS TRANSPLANTATION (2023)

Article Chemistry, Analytical

Camera-Derived Photoplethysmography (rPPG) and Speckle Plethysmography (rSPG): Comparing Reflective and Transmissive Mode at Various Integration Times Using LEDs and Lasers

Jorge Herranz Olazabal, Fokko Wieringa, Evelien Hermeling, Chris Van Hoof

Summary: This study compares the effects of integration time and light-source coherence on signal quality and waveform morphology for reflective and transmissive speckle plethysmography (SPG) and photoplethysmography (PPG). The results show that the signal quality of SPG and PPG varies under different light sources and coherence conditions.

SENSORS (2022)

Review Engineering, Biomedical

Wearable and implantable artificial kidney devices for end-stage kidney disease treatment-Current status and review

Thomas Groth, Bernd G. Stegmayr, Stephen R. Ash, Janna Kuchinka, Fokko P. Wieringa, William H. Fissell, Shuvo Roy

Summary: Chronic kidney disease is a leading cause of early mortality worldwide, but access to kidney replacement therapy is limited due to various factors. Researchers from different fields are collaborating to develop wearable and/or implantable artificial kidneys that can provide long-term effective kidney functions. The goal is to create easily accessible and affordable options that can improve the quality of life and life expectancy for CKD patients.

ARTIFICIAL ORGANS (2023)

Article Biology

Near-Infrared Spectral Similarity between Ex Vivo Porcine and In Vivo Human Tissue

Eva de Vries, Lejla Alic, Rutger M. M. Schols, Kaj S. S. Emanuel, Fokko P. P. Wieringa, Nicole D. D. Bouvy, Gabrielle J. M. Tuijthof

Summary: This study assesses the spectral similarity between ex vivo porcine and in vivo human spectral data of nerve and adipose tissue, in order to generate large datasets for improved clinical classification.

LIFE-BASEL (2023)

Article Biotechnology & Applied Microbiology

Comparing Remote Speckle Plethysmography and Finger-Clip Photoplethysmography with Non-Invasive Finger Arterial Pressure Pulse Waves, Regarding Morphology and Arrival Time

Jorge Herranz Olazabal, Fokko Wieringa, Evelien Hermeling, Chris Van Hoof

Summary: The objective of this study was to compare the Pulse Wave Morphology (PWM) and Pulse Arrival Time (PAT) of Speckle plethysmography (SPG) and Photoplethysmography (PPG) with non-invasive finger Arterial Pressure (fiAP). Healthy volunteers were connected to a Non-Invasive Blood Pressure (NIBP) monitor and other devices to record various signals. The results showed that SPG had a higher similarity to fiAP in terms of PWM compared to PPG, while there was no significant difference in PAT values between ECG-SPG and ECG-PPG.

BIOENGINEERING-BASEL (2023)

Proceedings Paper Computer Science, Interdisciplinary Applications

Beat-to-beat Intervals of Speckle & Intensity-based Optical Plethysmograms compared to Electrocardiogram

Jorge Herranz Olazabal, Fokko Wieringa, Evelien Hermeling, Christopher Van Hoof

Summary: This study demonstrates that contactless camera-derived rSPG can obtain beat-to-beat intervals at least as good as routine clinical contact-mode transmissive finger clip PPG, potentially enabling innovative applications.

2021 COMPUTING IN CARDIOLOGY (CINC) (2021)

No Data Available