Results 131 to 140 of about 600,282 (299)

Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis. [PDF]

Neurosurg Pract
Bhenderu LS, Gupta P, Schindler A, Kumar S, Cruz-Garza JG, Hassan T, Hoang A, Britz GW, Faraji AH, Yaeger KA.   +9 more
europepmc   +1 more source

Transforming Brain Organoids Into Functional Platforms: Convergence of Engineering, Imaging, AI, and Ethics

Advanced Science, EarlyView.
Brain organoids are emerging as increasingly functional human‐relevant platforms, yet limitations in vascularization, maturation, measurement, and reproducibility still constrain their translational value. This Perspective examines how microfluidics, biofabrication, advanced imaging, electrophysiology, multimodal AI, standardization, and ethical ...
Aishwarya Pantula, Kaustubh Joshi, Swarangi Samant, Greta Babakhanova, Annie Kathuria   +4 more
wiley   +1 more source

R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27

Journal of Comparative Effectiveness Research
In this update, we review the US FDA’s updated compendium of real-world evidence (RWE) use in medical device regulatory decisions, a comprehensive scan of RWE utilization in Canadian drug reimbursement submissions, and Institute for Clinical and ...
Paul Arora, Sreeram V Ramagopalan
doaj   +1 more source

The US Food and Drug Administration's TEMPO Pilot Signals a New Regulatory Approach for AI-Enabled Medical Devices. [PDF]

J Med Internet Res
Athni TS.
europepmc   +1 more source

Smart Nanotechnologies for Multimodal Neuromodulation and Brain Interfacing

Advanced Science, EarlyView.
Recent advances in smart nanotechnologies are expanding the toolbox for brain interfacing, from wireless neuromodulation and high‐resolution sensing to targeted delivery within the central nervous system. By combining responsive nanomaterials with bioinspired design, these platforms enable multimodal interactions with neurons and glia, while also ...
Tommaso Curiale, Marie Celine Lefevre, Alessio Carmignani, Maria Cristina Ceccarelli, Matteo Battaglini, Attilio Marino, Gianni Ciofani   +6 more
wiley   +1 more source

Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications. [PDF]

Clin Transl Sci
Tsakalozou E, Erdman R, Zhang L, Lionberger R, Fang L.   +4 more
europepmc   +1 more source

FDA enforcement report

core   +4 more sources

Nanomaterials for Allergy Diagnosis and Treatment: Advances, Opportunities and Translational Challenges

Advanced Science, EarlyView.
Nanomaterials offer dual applications in allergy management. For diagnosis, nanomaterials enhance analytical sensitivity and improve detection in specific IgE and functional assays such as the basophil activation test (BAT). For allergen‐specific immunotherapy, nanomaterials enable allergen masking and controlled release, and effectively modulate the ...
Madiha Habib, Shan Jiang, Joyce ZX Lee, CW Lim, HL Yeung, Nicki YH Leung, Patrick SC Leung, Ting F Leung, Christine YY Wai   +8 more
wiley   +1 more source

A Practical Guide to Implementing Real-World Evidence as Primary Basis for Approval and Label Expansion. [PDF]

Clin Pharmacol Ther
Mayne TJ, Brookhart MA, Dreyer NA.
europepmc   +1 more source

FDA research [PDF]

Nature Medicine, 1997
S L, Epstein, B F, Anthony
openaire   +2 more sources