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Semiconductors01:22

Semiconductors

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There is variation in the electrical conductivity of materials - metals, semiconductors, and insulators that are showcased with the help of the energy band diagrams.
Metals such as copper (Cu), zinc (Zn), or lead (Pb) have low resistivity and feature conduction bands that are either not fully occupied or overlap with the valence band, making a bandgap non-existent. This allows electrons in the highest energy levels of the valence band to easily transition to the conduction band upon gaining...
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IP3/DAG Signaling Pathway01:11

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Membrane lipids such as phosphatidylinositol (PI) are precursors for several membrane-bound and soluble second messengers. Specific kinases phosphorylate PI and produce phosphorylated inositol phospholipids. One such inositol phospholipids are the  phosphatidylinositol-4,5 bisphosphate [PI(4,5)P2], present in the inner half of the lipid bilayer. Upon ligand binding, GPCR stimulates Gq proteins to turn on phospholipase Cꞵ. Activated phospholipase Cꞵ cleaves PI(4,5)P2 and...
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Interactions Between Signaling Pathways01:19

Interactions Between Signaling Pathways

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Signaling cascades usually lack linearity. Multiple pathways interact and regulate one another, allowing cells to integrate and respond to diverse environmental stimuli.
Convergence and divergence, and cross-talk between signaling pathways
Two distinct signaling pathways can converge on a single functional unit, which may either be a single protein or a complex of proteins. The response is either functionally distinct or synergistic between the two pathways but different from the response...
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Non-ohmic Devices00:51

Non-ohmic Devices

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In most substances, the current flow is proportional to the voltage applied to it. A simple relationship between the values of current, voltage, and resistance is known as Ohm's law. Nonohmic devices do not exhibit a linear relationship between voltage and current. One such device is the semiconducting circuit element known as a diode. A diode is a circuit device that allows current flow in only one direction.
Consider a simple circuit consisting of a battery, a diode, and a resistor. A...
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Regulation of Expression at Multiple Steps01:23

Regulation of Expression at Multiple Steps

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The gene expression in cells is regulated at different stages: (i) transcription, (ii) RNA processing, (iii) RNA localization, and (iv) translation. Transcriptional regulation is mediated by regulatory proteins such as transcription factors, activators, or repressors—these control gene expression by initiating or inhibiting the transcription of genes. Once a precursor or pre-mRNA is produced, it undergoes post-transcriptional modification, including 5' capping, splicing, and the...
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Diversity in Cell Signaling Responses01:22

Diversity in Cell Signaling Responses

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The physiological function of a cell and cellular communication are outcomes of a range of extrinsic signals, intracellular signaling pathways, and cellular responses. No two cell types express the same repertoire of signaling components. Receptors are highly selective for their cognate ligands, but once activated, they can alter multiple cellular processes such as DNA transcription, protein synthesis, and metabolic activity. 
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Bridging the Bio-Electronic Interface with Biofabrication
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Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

Ted Cho1, Vrushab Gowda2, Henning Schulzrinne3

  • 1University of California, San Francisco, California, USA.

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|January 22, 2024
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Summary

Current medical device regulations are outdated for software-heavy devices. A new voluntary pathway with two-stage review could help regulators adapt to the evolving medical device market.

Keywords:
Food and Drug Administrationhealth technologymedical devicesregulatory policy

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Area of Science:

  • Biomedical Engineering
  • Regulatory Science
  • Health Policy

Background:

  • Current medical device regulatory frameworks are over 50 years old.
  • These frameworks are inadequate for modern medical devices with substantial software components.
  • Existing regulatory efforts by the Food and Drug Administration (FDA) are limited by insufficient statutory authority.

Purpose of the Study:

  • To evaluate the suitability of current medical device regulatory frameworks for next-generation devices.
  • To identify lessons from international regulatory approaches for improving domestic policy.
  • To propose an alternative regulatory pathway to address the evolving medical device market.

Main Methods:

  • Analysis of existing medical device regulatory frameworks.
  • Review of international regulatory policies and practices.
  • Development of a proposed voluntary alternative pathway.

Main Results:

  • Current regulations are ill-suited for software-intensive medical devices.
  • International regulatory models offer valuable insights for policy improvement and harmonization.
  • A proposed voluntary pathway involves a two-stage review process: individual component review followed by holistic review for integrated devices.

Conclusions:

  • Medical device regulation requires modernization to accommodate software-driven innovation.
  • International best practices can inform domestic regulatory enhancements.
  • A novel voluntary pathway could equip regulators with necessary tools for the dynamic medical device landscape.