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Archives for 2026

ECRI Urges Congress to Strengthen Regulatory Transparency for Digital Health and CDS Tools

by Fred Pennic 05/01/2026 Leave a Comment

ECRI Urges Congress to Strengthen Regulatory Transparency for Digital Health and CDS Tools

What You Should Know ECRI, a nonprofit patient safety organization, submitted formal recommendations to the House Energy and Commerce Subcommittee on Health in April 2026.The organization warns that many general wellness devices—measuring vitals like blood pressure and glucose—lack FDA oversight and clinical validation, creating "invisible" risks for users.ECRI raised concerns regarding the Digital Health Screeners Act of 2026, specifically citing the lack of mandatory reporting for
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Medisolv Acquires Health Elements AI to Automate Data Abstraction and Expand Clinical Registry Support

by Jasmine Pennic 05/01/2026 Leave a Comment

Medisolv Acquires Health Elements AI to Automate Data Abstraction and Expand Clinical Registry Support

What You Should Know Medisolv, Inc. has acquired Health Elements AI, a specialist in AI-first software that automates the capture and structuring of clinical data from medical records. Financial details of the acquisition were not disclosed. The acquisition aims to reduce the significant administrative burden of manual chart review, which currently impacts more than 4,000 abstracters supported by Medisolv.Health Elements AI reports a 96 percent accuracy rate, leveraging AI and human oversight
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Parexel Acquires Vitrana to Integrate AI-Enabled Pharmacovigilance Platform

by Fred Pennic 05/01/2026 Leave a Comment

Parexel Acquires Vitrana to Integrate AI-Enabled Pharmacovigilance Platform

What You Should Know Parexel has acquired Vitrana, a provider of an AI-enabled, end-to-end pharmacovigilance (PV) technology platform.The acquisition allows Parexel to provide a fully integrated model where a single partner is responsible for both PV technology and services.The acquired platform is system-agnostic, integrating with any existing safety database to improve accuracy and cycle times.Key operational benefits include improved EDC-to-safety integration, streamlined Serious Adverse
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6 Strategies to Help Meet HR1 Eligibility and Enrollment Requirements

by Mike Hall, Chief Product Officer, Cúram by Merative 05/01/2026 Leave a Comment

HR1, also known as the One Big Beautiful Bill Act, significantly revised eligibility and enrollment processes for Medicaid and the Supplemental Nutrition Assistance Program (SNAP) benefits. With deadlines starting December 31, 2026, agencies must begin modernization efforts now to prevent costly delays. Health and human service agencies must take a thoughtful approach to these policy updates to help ensure compliance while continuing to deliver quality services. Six strategies include: 1.
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Axoft Secures $55M for Implantable Brain-Computer Interfaces and Fleuron™ Material Global Trials

by Fred Pennic 04/30/2026 Leave a Comment

Axoft Secures $55M for Implantable Brain-Computer Interfaces and Fleuron™ Material Global Trials

What You Should Know Axoft has raised an oversubscribed $55M Series A led by C.P. Group Innovation, bringing its total funding to over $60M.The capital will be used to expand global clinical trials, progress U.S. regulatory approval for its implantable Brain-Computer Interfaces (iBCIs), and build a GMP manufacturing facility in Cambridge, MA.Axoft’s iBCIs utilize a proprietary material called Fleuron™, which is 10,000x softer than traditional polyimide, significantly reducing tissue scarring
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Photon Raises $16M to Modernize AI-Native Prescription Infrastructure

by Fred Pennic 04/30/2026 Leave a Comment

Photon Raises $16M to Modernize AI-Native Prescription Infrastructure

What You Should Know Photon has secured $16 million in Series A funding led by Healthier Capital, with participation from Notation, Flare Capital, and Evidenced.The platform addresses the "information vacuum" of traditional e-prescribing, where patients choose pharmacies without knowing price, inventory, or convenience.Photon utilizes artificial intelligence as an engine to process complex, fragmented data across pharmacy networks and formularies in real time.The platform serves as an
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AiZtech Labs Launches iSelfie BioSignals in U.S. to Automate Intake and Digital Biomarker Detection

by Fred Pennic 04/30/2026 Leave a Comment

AiZtech Labs Launches iSelfie BioSignals in U.S. to Automate Intake and Digital Biomarker Detection

What You Should Know AiZtech Labs has officially launched iSelfie BioSignals in the U.S., a smartphone-based platform that detects digital biomarkers using a standard selfie-camera interaction.The platform is designed to generate clinically meaningful measurements from the eye and surrounding skin, helping care teams prioritize patients faster and reduce reliance on device-heavy hardware.Clinical validation includes data from over 5,000 human participants across six studies in the U.S.,
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Viz.ai and NRHA Collaborate to Deploy AI in Rural Hospitals

by Fred Pennic 04/30/2026 Leave a Comment

Viz.ai and NRHA Collaborate to Deploy AI in Rural Hospitals

What You Should Know Viz.ai has partnered with the National Rural Health Association (NRHA) through its Rural Hospital & Clinic Partnership Program to help rural leaders implement AI-powered detection and coordination tools.The initiative targets a significant "adoption gap": rural hospitals are currently 25% less likely to adopt new technologies like AI than urban facilities due to funding and geographic barriers.The Viz platform analyzes medical images and clinical data in real time to
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Healthcare AI Governance: Implementing NIST Trustworthy AI and OWASP Security Guardrails

by Marty Barrack, Chief Legal and Compliance Officer, XiFin, Inc. 04/30/2026 Leave a Comment

Building an 'AI-Ready' Healthcare Enterprise Using NIST and ISO Frameworks

In Part 1 of this series, we covered the foundation of an AI-ready healthcare organization: an organization-appropriate governance framework, regulatory awareness, and an AI inventory. Now, let's discuss the other essential capabilities for AI readiness: risk management and guardrails. Apply Enterprise Risk Management (ERM) to AI AI risk must be managed like other enterprise risks: Establish a risk framework Define your organization’s risk appetite and toleranceIdentify
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Greatly Health Secures $4M to Scale MSK-Validated Integrative Oncology Platform

by Fred Pennic 04/30/2026 Leave a Comment

Greatly Health Secures $4M to Scale MSK-Validated Integrative Oncology Platform

What You Should Know Greatly Health raised a $4 million seed round co-led by Pear VC and Commonweal Ventures to bring integrative oncology to a broader patient population.The company's virtual model was originally developed and validated at Memorial Sloan Kettering Cancer Center (MSK).In clinical trials, the program demonstrated a 16% absolute improvement in overall survival at two years and a 69% reduction in hospitalizations.The platform provides live, expert-led group sessions in exercise,
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Viz.ai Launches Viz Pulmonary™ Suite: AI-Powered Workflows for COPD, Lung Nodules, and PE

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