US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. This work occurs alongside evaluating how to integrate the medical device into the hospital system’s diagnostic paradigms, including in relation to quality improvement programs. Companies can have a role but there are 415 US hospital systems (comprising ~5,000 hospitals), and each has a bespoke process and ever-changing set of
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
BioIntelliSense Acquires Patient Monitoring Company AlertWatch
What You Should Know:
- BioIntelliSense, Inc. acquires AlertWatch, an FDA-cleared, clinically proven patient monitoring solution. AlertWatch uniquely provides robust integration, data analysis and a patented intuitive display of contextual patient data for more efficient, actionable clinical decisions.
- As part of the recently announced strategic partnership with Medtronic, its Patient Monitoring business will distribute AlertWatch to hospitals throughout the U.S.
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Viome Raises $67M to Expand Microbiome & At-Home Test Kits
What You Should Know:
- Viome Life Sciences, a mission-driven digital health company, announced additional $67M in funding toward its Series C round.
- Led by Bold Capital Group, the $67M raise brings the company’s total funding to over $150M and will be used to support the development of its at-home tests that leverage precision nutrition to improve health and increase longevity by addressing the epidemic of chronic diseases, cancers, and aging.
- Viome will expand its proprietary mRNA
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Eyenuk Raises $26M for AI-Powered Eye Screening & Predictive Biomarkers
What You Should Know:
- Eyenuk, Inc., a global artificial intelligence (AI) digital health company and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, today announced it has secured $26 million in a Series A financing round, bringing the Company’s total funding to over $43 million.
- The capital raise was led by AXA IM Alts and was joined by new and existing investors including T&W Medical A/S, A&C Foelsgaard Alternativer ApS, Kendall
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Eclipse and Mayo Clinic Create Nucleus RadioPharma for Cancer Patients
What You Should Know:
- Eclipse, a venture capital firm investing in the digital transformation of the world's physical industries, and Mayo Clinic, a leading nonprofit health organization, recently announced the creation and seed funding of Nucleus RadioPharma, a new company built to ensure cancer patients can access potentially life-saving radiopharmaceuticals by developing technologies to modernize the clinical development, manufacturing, and supply chain of these promising new
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Research: AI Outperforms Ophthalmologists at Detecting Eye Disease
What You Should Know:
- A new study published in Ophthalmology Science, a peer-reviewed journal of the American Academy of Ophthalmology, found that Artificial Intelligence is significantly better at detecting diabetic retinopathy (DR) than eye specialists. DR is the leading cause of blindness among working-age adults yet is easily treatable with early detection.
- The multi-center study evaluated the FDA-cleared EyeArt AI system against dilated eye exams
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KLAS: State of Digital Pathology Among Early Adopters in 2022
What You Should Know:
- In anticipation, many technology vendors are vying for a foothold in the US, leading to a highly varied landscape. In partnership with the Digital Pathology Association (DPA), KLAS surveyed 55 provider organizations (including hospitals, health systems, academic health centers, and reference labs) to assess the state of digital pathology among pioneers in the US and determine which vendors are gaining traction.
- 33 of the interviewed organizations are live with
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Accommodations Increase Clinical Trial Participation for Patients of Color, Survey Reveals
What You Should Know:
- In a recent patient-centric survey, SubjectWell found that accommodations for all patients, including free treatment and study compensation, increase interest in clinical trial participation – particularly for patients of color.
- However, overall, using value-based messaging, adding education to the recruiting process and reducing friction to participation – are universally impactful, not just for diverse populations, and that certain barriers
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Qnovia Secures $17M to Advance Inhalable Therapeutics Pipeline
What You Should Know:
- Qnovia (formerly Respira Technologies)—a pharma company developing inhaled therapeutics with an initial focus on nicotine replacement therapy (NRT) and cardiopulmonary diseases—has raised $17M in Series A funding led by Blue Ledge Capital and included DG Ventures, Evolution VC Partners, Gaingels, TL Capital, and Vice Ventures.
- Qnovia will use the Series A proceeds to advance its NRT drug candidate through an IND submission with the FDA and begin human
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Optellum Raises $14M for AI-Enabled Lung Cancer Diagnosis
What You Should Know:
- Optellum, an Oxford-based digital health company that provides a breakthrough AI platform to diagnose and treat early-stage lung cancer raises $14M in Series A funding led by Mercia, with additional investors Intuitive Ventures and Black Opal Ventures. Existing investors, including St John's College in the University of Oxford, IQ Capital, and the family office of Sir Martin & Lady Audrey Wood, also participated in this round.
- The investment will enable
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