Oct. 14, 2024 – The Institute for AI Governance in Healthcare (IAIGH) has published the draft Healthcare AI Governance Standard (HAIGS) for public comment.

The comment period opened Oct. 14, 2024, and closes Nov. 14, 2024.

The draft standard is available for review and feedback at AiHealthcareGovernance.org.

Oct. 15, 2024 – Elucid has announced that four of the seven Medicare Administrative Contractors (MACs) will extend coverage for AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ image analysis software, beginning Nov. 24, 2024.

On Nov. 13, 2024, HIMSS will be presenting a webinar on "Addressing the Changing Data Demands of Next-Gen Healthcare."

The webinar will take place at 1 p.m. Central time.

The delivery of next-generation patient care relies upon seamless access to comprehensive and relevant patient data. However, the proliferation of patient data silos across multiple hosted environments can present significant integration challenges. To ensure that the full potential of next-generation healthcare solutions is realized, healthcare providers must rethink their data strategy.  

Oct. 2, 2024 — Eko Health recently announced a new independent study from researchers at Imperial College London (Imperial) that demonstrated how AI can identify patients with significantly higher risk of experiencing major adverse cardiac events (MACE), including heart attacks and heart failure. Researchers used Eko Health's FDA-cleared and UKCA-marked Low Ejection Fraction AI to conduct the study, which reinforced the power of Eko's AI for early detection while also showing its potential to improve cardiovascular care in both clinical and remote settings.

Heart failure is a rapidly growing public health issue that can be difficult to manage on a global scale. But there are tools that exist that can improve outcomes, such as guideline-directed medical therapy (GDMT). New UCLA-led research highlights the important role that these guidelines can play in reducing mortality rates for individuals suffering from heart failure with reduced ejection fraction (HFrEF), a type of heart failure affecting an estimated 29 million people worldwide.

PHOTO CAPTION: The Elucid PlaqueIQ user interface is a fully interactive visualization of the patient’s coronary anatomy, showing specific plaque type and amount across various views to inform physician assessment of risk and patient-specific treatment pathway. The original CT image is preserved to provide further context.

 

Elucid has announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease (CVD).

Sept. 24, 2024 — Thrombolytic Science, LLC (TSI) has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme. A U.S.-based clinical trial will further confirm the safety and tolerability of TSI's novel mutant prourokinase (mproUK) in healthy volunteers.

Sept. 18, 2024 – Astellas Pharma Inc. recently announced that Digitiva, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA).

Digitiva is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission*. Digitiva is the first digital health offering from Astellas in the U.S.

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