Iris

Canon Announces Firmware Updates Delivering Enhanced Features for Cinema EOS Cameras and Pro Camcorders

Retrieved on: 
Mittwoch, Juni 5, 2024
EOS, RAW, Canon Cinema EOS, VR, OSD, Iris, R5, Camera

Melville, NY, June 05, 2024 (GLOBE NEWSWIRE) -- Canon U.S.A., Inc., a leader in digital imaging solutions, announced today a variety of firmware updates for key models in its Cinema EOS and professional camcorder line of cameras, including the EOS C500 Mark II, EOS C300 Mark III, EOS C70, EOS R5 C cameras and the XA75/70, XA65/60 and VIXIA HF G70 camcorders.

Key Points: 
  • Melville, NY, June 05, 2024 (GLOBE NEWSWIRE) -- Canon U.S.A., Inc., a leader in digital imaging solutions, announced today a variety of firmware updates for key models in its Cinema EOS and professional camcorder line of cameras, including the EOS C500 Mark II, EOS C300 Mark III, EOS C70, EOS R5 C cameras and the XA75/70, XA65/60 and VIXIA HF G70 camcorders.
  • All updates are a direct result of customer feedback and will be available through a free download at the end of June 2024.
  • Same Focus Guide and playback marker enhancements as the C500 Mark II and C300 Mark III cameras will be added.
  • To download the firmware updates once available, or for more information regarding the firmware updates and all of Canon’s professional video products and solutions, please visit usa.canon.com .

Canon Announces New EOS C400 6K Full-Frame RF Mount Cinema Camera and RF-Mount CINE-SERVO Lens

Retrieved on: 
Mittwoch, Juni 5, 2024
EOS, RAW, CMOS, Communication, VR, MP4, RF, 3G, IP, XF, Ethernet, Metadata, DIN, XC, ISO, SD card, ARIA, CFexpress, Illumination, Optical disc image, SRT, Iris, ZEISS, HDMI, Workflow, Camera

Canon is also proud to announce the company’s first MOUNT ADAPTER PL-RF, and an RF-mount version of the popular and award-winning CINE-SERVO 17-120mm cinema lens.

Key Points: 
  • Canon is also proud to announce the company’s first MOUNT ADAPTER PL-RF, and an RF-mount version of the popular and award-winning CINE-SERVO 17-120mm cinema lens.
  • The EOS C400 camera records in 6K full-frame up to 60p in 12-bit Cinema RAW Light.
  • Ready for 180-degree VR shooting, the EOS C400 camera has built-in compatibility with the Canon RF5.2mm F2.8 L dual fisheye lens.
  • The Canon Cinema EOS C400 Full-Frame RF Mount Camera is scheduled to be available in September 2024 for an estimated retail price of $7,999.00*.

Procedural advice on paediatric applications

Retrieved on: 
Montag, Juni 3, 2024
Well, Template, Skin, RFM (market research), PPSR, Pip, Health, Annual report, INN, International, Medicine, Communication, Cisco Webex, Council, European Commission, Domenico, EMA, Brochure, Documentation, MAH, Medication package insert, Risk, Pediatrics, Name, Research, European, Medication discontinuation, Marketing, Trial of the century, European Medicines Agency, European Pharmacopoeia, Procedural, Patient, Waivers, Draft, GMA, Literature, Adobe Connect, Civil service commission, Iris, RPI, Classification, European Parliament, ICH, SMS, FDA, Directive 2001/83/EC, Confirmation, Collection, PUMA, PIP, Conference, ZIP, Element, Committee, Medical device

Procedural advice on paediatric applications

Key Points: 
    • 9 Human Medicines Division Procedural advice on paediatric applications Guidance for applicants 1 1 To be consulted together with the IRIS guide for applicants.
    • Placing paediatric medicines on the market ......................................................... 15 Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • Regulation (EC) No 1901/2006 (the 'Paediatric Regulation') lays down obligations, rewards and incentives for the development and placing on the market of medicines for use in children.
    • Where results of paediatric studies are submitted, applicants should include in the clinical overview a rationale supporting the proposed changes to the Product Information.
    • Further information can be found in the Procedural Advice document on ?applications for PIPs, Waivers and Modifications.
    • However, the following types of application are exempted from the application of the above requirements: Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • Objectives The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007.
    • Its main impact was the establishment of the Paediatric Committee (PDCO), which is responsible for coordinating the Agency's work on medicines for children.
    • For pre-submission interactions: Send a question to the European Medicines Agency Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • for modification of a paediatric investigation plan) it is suggested to record all successive name changes in the document.? Invented name: The trade name of a medicine.
    • In general paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population, where appropriate, before marketing authorisation applications are submitted.
    • It is often referred to as full waiver as it is related the age range covering all paediatric subsets.
    • During the second PDCO discussion, either a request for modification (RfM) or PDCO opinion is adopted: Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • Opinion According to Article 25(1) of the Paediatric Regulation (Regulation (EC) No 1901/2006), within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.
    • The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for the related initial PIP: ? Detailed grounds for re-examination in a Word document Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • EMA decision According to Article 25(5) of the Paediatric Regulation (Regulation (EC) No 1901/2006), the Agency issues its decision within 10 days of the Paediatric Committee's definitive opinion.
    • The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for Discontinuation of paediatric development: Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • See also: Deadlines for placing paediatric medicines on the market Procedural advice on paediatric applications EMA/672643/2017 Rev.

Bausch + Lomb Announces Presentation of New Scientific Data and Evaluations Featuring Consumer, Vision Care and Pharmaceutical Products at Optometry’s Meeting®

Retrieved on: 
Dienstag, Mai 28, 2024
Research, General Health, Pharmaceutical, Optical, Specialty, Retail, Clinical Trials, Science, Surgery, Medical Supplies, FDA, Health, The Bell Tower, Trial of the century, Viral, Bausch, Allergy, OD, Inflammation, Steroid, Fungal infection, Action, OnDemand, AOA, Telecanthus, CDT, Glaucoma, Sclera, Infection, Intraocular pressure, Contact, American Optometric Association, Conjunctiva, Cerebral edema, Music City Center, Macular edema, Complex, Eye injury, Thought, System, Employment, Convention, Contact lens, Slit lamp, Vaccinia, Patient, Incidence, Safety, Keratitis, Bausch & Lomb, Herpes simplex, Visual acuity, Taste, Iris, Eyelash, Risk, IOP, Lens (vertebrate anatomy), Astigmatism, Pigment, Efficacy, Verge, Ocular hypertension, Eye, Abstract, Human, Pain, Optic nerve, History, Palm, Chickenpox, EYE

The OnDemand ePosters will feature new data on the early adoption of MIEBO and real-world patient experiences with Bausch + Lomb INFUSE® Multifocal silicone hydrogel daily disposable contact lenses.

Key Points: 
  • The OnDemand ePosters will feature new data on the early adoption of MIEBO and real-world patient experiences with Bausch + Lomb INFUSE® Multifocal silicone hydrogel daily disposable contact lenses.
  • “Evaluation of the Efficacy of a Novel Preservative-Free Formulation of Brimonidine Tartrate Ophthalmic Solution.” Evans et al.
  • “Improvement in Non-Invasive Tear Break-Up Time after Instillation of One Drop of Brimonidine Tartrate 0.025%.” Moore et al.
  • During the event, attendees will have the opportunity to learn about Bausch + Lomb’s latest innovations, including Bausch + Lomb INFUSE® for Astigmatism and Blink NutriTears.

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1

Retrieved on: 
Dienstag, Mai 28, 2024
Commission, Telephone, European Medicines Agency, Agency, Scope, DPR, Administrator, Interface, International Organization for Standardization, Chapter Two, Access, Disclosure, IRIS, Product lifecycle, Letter, GDPR, PUI, European Commission, ID, General Data Protection Regulation, Reproduction, ISO, Annex, European, Use, OMS, API, Chapter One, Chapter Five, IAM, Identification, NCA, Safety, Marketing, Public, Administration, EAF, Iris, PLM, ABC, Chapter Three, Document, UI, Information management, Chapter Six, Person, Data management, EMA, RMS, International Organization (journal), User, Competence, Medical device

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1

Key Points: 
    • Training .................................................................................................................................................... 13

      Product Management Service (PMS) - Implementation of International Organization for
      Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
      Europe
      EMA/676105/2019

      Page 2/13

      Summary of changes
      Following the publication of version 2 in February 2021, the following sections were updated:
      ?

      PMS Registration requirements;

      ?

      Access to data;

      ?

      Training.

    • Scope of this document
      This document has been developed with the goal of facilitating the maintenance and accessibility to
      data on medicinal products for human use in the EU.
    • Scope of PMS
      The scope of PMS is to have harmonised data and definitions to uniquely identify a medicinal product
      based on regulated information (e.g.
    • Therefore, users shall read this chapter in
      conjunction with the 'On-boarding of users to Substance, Product, Organisation and Referentials
      (SPOR) data services' document.
    • In order to start this process the user has to confirm the registration of the relevant organisation in
      Organisation Management Service (OMS).
    • Product Management Service (PMS) - Implementation of International Organization for
      Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
      Europe
      EMA/676105/2019

      Page 4/13

      User can check whether the relevant organisation is in OMS by searching using 'Request Access for
      Organizations' at EMA account management.

    • Product Management Service (PMS) - Implementation of International Organization for
      Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
      Europe
      EMA/676105/2019

      Page 10/13

      Is the user Organisation
      in OMS?

    • For further information on how data are classified please refer to EU IG
      Chapter 5 and Annex A to Chapter 5.
    • Product Management Service (PMS) - Implementation of International Organization for
      Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
      Europe
      EMA/676105/2019

      Page 12/13

      5.

    • Additional information on the location of the training materials
      will be made available in future updates of this chapter.
    • At the time of the PMS go live foreseen in Q2 2024, users will have read-only privileges in PMS.
    • The
      enabling of the write privileges will be released for specific set of PMS data elements at later stage in
      Q4 2024.
    • Product Management Service (PMS) - Implementation of International Organization for
      Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
      Europe
      EMA/676105/2019

      Page 13/13

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Retrieved on: 
Dienstag, Mai 28, 2024
Transfer, Steps, Scroll, SPC, Q&A, Google Chrome, European Medicines Agency, VET, Lead, Product lifecycle, Medical device, EMA, GVP, Canonical form, Common, NOT, Companion, PO, Chikungunya, Nature, Location, Button, Sponsor, Task force, PV, Web browser, Public, Workflow, Iris, Outcome, Purchase order, Partex Group, Prevalence, Update, Person, Medicine, Committee, Record, Approximation error, Protocol, Risk, Availability, EEA, Bulk, CVMP, Figure, Signal, PHE, Language, Zika virus, ECTD, Letter, SharePoint, Authorization, Name, Communication, Inspectorate, MIA, PRIME, MAA, Reproduction, European, Glass, Chromium, Section, Marketing, PIP, EAF, Organization, Safety, PLM, Mode, SAS, Treatment, ETF, Sunset, MAH, Standard, MSD, Directive 2001/83/EC, GMP, Public health, Self-management, Union, MSO, Report, Microsoft Excel, Browser, GCP, Civil service commission, N.B, Common Technical Document, VSI, Section 8, Qualification, Withdrawal, Date, Draft, SME, Abbreviation, Access management, Headquarters, PDF, Diagnosis, Section 4, HR, State, History, NEXT, PASS, PSMF, RPI, Save, MB, Inspection, SAP, COVID, Process, Research, Validation, VS, SAWP, Art, European Commission, Translation, Literature, PD, Public Security Section 9, Clinical trial, PRI, Brief, Submission, Annual report, ITF, KOM, Substance, Marketing authorisation, Parallel, Documentation, Contact lens, Human, CHMP, Risk management

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Key Points: 

    Dynexus’ Rapid EIS Shows Distinct Battery Safety Advantage

    Retrieved on: 
    Dienstag, Mai 14, 2024
    Technology, Research, Semiconductor, Other Energy, Energy, Batteries, Hardware, Data Management, Science, Lithium, Intelligence, EIS, Fire, Montana Technological University, Iris, BMS, Failure, Temperature, Printed circuit board

    According to the paper published in February, “In scenarios of excessive temperature leading to failure of single cells, the use of rapid EIS showed a distinct advantage over gas sensors for early detection.

    Key Points: 
    • According to the paper published in February, “In scenarios of excessive temperature leading to failure of single cells, the use of rapid EIS showed a distinct advantage over gas sensors for early detection.
    • The award winning inline Rapid Impedance Spectroscopy (iRIS®) sensors generate near real-time, rich, frequency-based battery data that provide information about the state of a battery's physico-chemistry.
    • With growing concerns regarding lithium-ion battery fires, active monitoring of the state of stability of battery systems is critical to avoid loss of life and property.
    • “Dynexus is commercializing the only active energy management system with this capability,” said David Sorum, CEO of Dynexus Technology.

    Exo® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure

    Retrieved on: 
    Dienstag, April 23, 2024
    Technology, Medical Devices, FDA, Health Technology, Cardiology, Software, Other Health, Health, Artificial Intelligence, Stroke, Ecosystem, LVEF, Hip, Pulmonary edema, Heart, Echocardiography, Patient, Physician, POCUS, Caregiver, Northwestern Medicine, CHF, Lung, Iris, Multimedia, Diagnosis, Heart failure, Emergency medicine, COPD, Medical device

    The number of Americans with heart failure today is over 6.7 million and growing.

    Key Points: 
    • The number of Americans with heart failure today is over 6.7 million and growing.
    • While echocardiography is the cornerstone of heart failure diagnosis, it is costly and requires highly trained sonographers to use it.
    • Exo’s revolutionary ecosystem includes Exo Iris, as well as a fast-growing suite of AI solutions and its award-winning POCUS workflow software, Exo Works® .
    • To purchase Exo Iris and the rest of Exo’s medical imaging ecosystem, visit Exo’s website or contact us to learn more.

    Vero AI Evaluates 10 Leading Generative AI Models Using Its Comprehensive VIOLET Framework to Gauge Responsible AI

    Retrieved on: 
    Dienstag, April 16, 2024
    Element, Gemini, Integrity, AI, OpenAI, Meta, Artificial intelligence, Gen, Amazon, White, Risk management, Human, Documentation, Algorithm, Synthetic media, Privacy, Visibility, Legislation, TITAN, Iris, Ethics, Cohere, Organization, Growth, Medical device

    CHAPEL HILL, N.C., April 16, 2024 /PRNewswire/ -- Vero AI, a first-of-its-kind analytical engine and scoreboard that helps enterprises fully harness the potential of advanced technology including artificial intelligence while minimizing risk, announced the findings of its inaugural "Generating Responsibility: Assessing AI Using AI" report. Vero AI's report provides a comprehensive assessment with measurable scores of 10 prominent generative AI models, to help enterprises understand how these tools align with responsible AI standards as determined by Vero AI's VIOLET Impact Model™. The model was created by I/O psychologists and AI technology veterans.

    Key Points: 
    • Vero AI's report provides a comprehensive assessment with measurable scores of 10 prominent generative AI models, to help enterprises understand how these tools align with responsible AI standards as determined by Vero AI's VIOLET Impact Model™ .
    • "As generative AI continues to rapidly evolve, organizations are increasingly challenged to grasp its benefits and potential risks," said Eric Sydell, PhD., CEO and co-founder.
    • Generative AI models are aiming for a responsible approach to AI, but the task at hand is large
      Most generative AI models have posted responses to calls from the White House to manage the risks posed by AI, on their websites.
    • There is a full list of scores for each of the 10 generative AI models in the report.

    DIGITAL THERAPEUTICS STARTUP RESPIREE™ ANNOUNCES INCORPORATION IN US WITH RESIDENCY AT JLABS @ SAN FRANCISCO

    Retrieved on: 
    Montag, April 15, 2024
    Lung, FDA, Johnson & Johnson, Biomarker, Patient, Iris, Pharmaceutical industry

    By expanding footprint within the US, Respiree aims to deepen its relationships and networks within the pharma and life science sector.

    Key Points: 
    • By expanding footprint within the US, Respiree aims to deepen its relationships and networks within the pharma and life science sector.
    • Respiree was formerly a company at JLABS in Singapore.
    • Respiree's team also aims to extend the development of its novel digital therapeutics pipeline to incorporate real-world pharma evidence.
    • "We are very proud and excited to be continuing our JLABS journey, first as alumni of JLABS @ Shanghai, then JLABS Singapore and now to JLABS @ South San Francisco.