Quality, Compliance & Regulatory - software & AI news

Daily news on software, AI, and companies shaping quality, compliance & regulatory.

Showing 124 results
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Sep 30, 2026

Gluware Extends Its Automation Platform Beyond the Network to Connected Medical Devices

New IoMT Exposure Management solution automates hospital vulnerability remediation, from disclosure to documented patchSACRAMENTO, Calif., Sept. 30, 2026 /PRNewswire/ -- Gluware, Inc., the intelligent automation company, today announced Gluware IoMT Exposure Management, bringing its proven automation platform to the Internet of Medical Things (IoMT) — the infusion pumps, imaging systems, patient monitors, and clinical workstations at the center of care delivery. The solution automates what happe
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Sep 30, 2026

DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years

Châtillon, France, September 29, 2026 DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years The BLA is supported by the results from the successful Phase 3 VITESSE trial – the largest immunotherapy clinical trial to date for this population. DBV has requested Priority Review of the BLA. DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, to
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Sep 28, 2026

Sun Nuclear to Unveil New Innovations Aimed at Strengthening Clinical Confidence at ASTRO 2026

New linac health command center turns fragmented QA data into early warnings of machine failureDedicated talks, demos and hands-on experience highlight Mirion Medical solutions for radiopharmaceutical therapy (RPT) programsMELBOURNE, Fla.--(BUSINESS WIRE)--Sun Nuclear, a Mirion Medical company, will bring next-generation innovations for next-level confidence to the ASTRO 2026 Annual Meeting, beginning Sunday, September 27, in Boston. At Booth 915, attendees will get a first look at new solutions
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Sep 27, 2026

Cuvo Health Publishes 2026 State-by-State Virtual Clinic Compliance Report: 33 of 51 Jurisdictions Restrict the Corporate Practice of Medicine

Free 51-jurisdiction dataset maps compact licensing, telehealth registration, nurse practitioner authority and MSO rules for white-label virtual clinics and digital health startups. Only 14 states offer out-of-state physicians a telehealth registration or telemedicine license.WILMINGTON, Del., Sept. 27, 2026 /PRNewswire/ -- Cuvo Health, the white label telehealth platform operated by Medstra Inc., today published the 2026 State-by-State Virtual Clinic Compliance Report, a dataset covering all 50
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Sep 24, 2026

Glytec Receives FDA Breakthrough Device Designation for Glucommander Pediatrics, an Insulin Management Technology for Hospitalized Newborns and Infants

The designation covers hospitalized newborns and infants from birth to less than 2 years of age, a population for which no insulin dosing recommendation software has been FDA-cleared.ATLANTA, Sept. 24, 2026 /PRNewswire/ -- Glytec, the healthcare technology company behind the FDA-cleared Glucommander, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for Glucommander Pediatrics, a proposed insulin dosing recommendation algorithm for hospitalize
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Sep 23, 2026

Oxford Biomedica Advances Global Quality Transformation with Veeva Quality Cloud

Leading CDMO unifies quality operations across the U.K., France, and the U.S., with VeevaBARCELONA, Spain, Sept. 23, 2026 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that the global contract development and manufacturing organization, Oxford Biomedica (OXB) will drive its quality transformation with Veeva Quality Cloud. Specializing in advanced cell and gene therapies, OXB will partner with Veeva to accelerate time to market for clients and support its fast-growing viral vector ma
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Sep 22, 2026

Hedia Secures Regulatory Approval to Expand Digital Diabetes Care to Pediatric Patients

Updated MDR certification unlocks pediatric care, broader insulin regimen support, and expanded device connectivity across Hedia's standalone app and partner platforms.COPENHAGEN, Denmark, Sept. 22, 2026 /PRNewswire/ -- Danish digital therapeutics company Hedia announced a major regulatory milestone, having secured official Medical Device Regulation (MDR) certification to expand its digital diabetes support to pediatric care. This clearance grants Hedia the right to remove its previous 18+ age r
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Sep 21, 2026

Körber Launches K.AI Assistant for Trusted AI in GxP Life Sciences Operations

Körber has unveiled the K.AI Assistant, a generative AI tool specifically tailored for the pharmaceutical and life sciences sectors, addressing the unique challenges of regulated environments.This innovative assistant is designed to provide operators and quality teams with streamlined access to Körber's product knowledge and GxP documentation, while minimizing the risks associated with unreliable AI-generated responses. In regulated processes, where compliance with Good Practice (GxP) is critica
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Sep 14, 2026

MediBeacon passes three audits in six weeks with zero major findings using Greenlight Guru

Medical device company relied on Greenlight Guru's eQMS to stay audit ready across ISO 13485, MDSAP, and MDR reviewsINDIANAPOLIS, Sept. 14, 2026 /PRNewswire/ -- Greenlight Guru, the leading provider of quality management, product development, and clinical data solutions for medical device companies, today announced that longtime customer MediBeacon passed three audits in a six-week span with zero major findings, using Greenlight Guru's eQMS to manage every stage of preparation and review.MediBea
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Sep 14, 2026

MethodSense Launches LuminLogic NextGen to Transform MedTech Compliance

AI-Enabled Platform Embeds 25+ Years of Regulatory and Quality Expertise to Accelerate Product CommercializationRALEIGH, N.C., Sept. 14, 2026 /PRNewswire/ -- Today MethodSense® announced the launch of LuminLogic® NextGen, a new AI-enabled quality and regulatory compliance platform that unifies eQMS, regulatory intelligence, submission readiness, and compliance management into a single solution. The platform delivers a fully configured, compliance-ready system in as little as one day rather than
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Sep 10, 2026

MHK and MCG Partner to Connect Evidence-Based Clinical Guidance with Standards-Based Prior Authorization

New integration to help health plans streamline prior authorization and prepare for CMS-0057-F complianceSEATTLE, Sept. 10, 2026 /PRNewswire/ -- MCG Health, part of the Hearst Health network and the industry's source of truth for trusted clinical guidance, announces a newly certified integration with MHK, a leading healthcare technology provider and a sibling Hearst Health company. The new integration connects the MCG Path interoperability solution directly with the MHK CareProminence prior auth
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Sep 3, 2026

News by ACCESS Newswire on TradingView, 2026-09-03

DistillerSR is set to play a pivotal role in the DIGICAP project, aimed at revolutionizing the conformity assessment process for medical devices and in vitro diagnostics across Europe.The DIGICAP initiative, backed by €4 million in funding from the Horizon Europe program, unites 19 organizations from 12 EU countries to transition from traditional document-based assessments to a more efficient, machine-readable format. DistillerSR, recognized as one of five key technology providers, will collabor