Classification

equipifi Successfully Completes SOC 2 Type 2 Audit

Retrieved on: 
Thursday, September 12, 2024
SOC 2, Software, SOC, Classification, American Institute, Trust, BNPL, Certified Public Accountant, AICPA, Organization, Audit

equipifi completes SOC 2® Type 2 Audit to further its commitment to security as it partners with financial institutions to launch Buy Now, Pay Later

Key Points: 
  • equipifi completes SOC 2® Type 2 Audit to further its commitment to security as it partners with financial institutions to launch Buy Now, Pay Later
    SCOTTSDALE, Ariz., Sept. 12, 2024 /PRNewswire/ -- equipifi , a leading platform providing Buy Now, Pay Later (BNPL) for financial institutions, announced the successful completion of its SOC 2 Type 2 audit.
  • "Our SOC 2 Type 2 audit reflects our commitment to our valued clients and partners."
  • "Congratulations to equipifi for completing their SOC 2 audit, a widely recognized signal of trust and security," said Steve Simmons, COO of A-LIGN.
  • "It's great to work with organizations like equipifi, who understand the value of expertise in driving an efficient audit and the importance of a high-quality final report."

REDBREAST IRISH WHISKEY UNVEILS NEW PERMANENT EXPRESSION TO THE REDBREAST FAMILY: INTRODUCING REDBREAST 18 YEAR OLD

Retrieved on: 
Thursday, September 12, 2024
Sherry, ISC, Tannin, Fruit, Spice, MSRP, Gold medal, Classification, Master blender, Midleton Distillery, Beverage Testing Institute, Ageing, Nose, Wine, Ginger, Beer

NEW YORK, Sept. 12, 2024 /PRNewswire/ -- Redbreast, Ireland's most awarded single pot still whiskey* announced the release of its latest expression, Redbreast 18 Year Old. This new member of the Redbreast family has been meticulously crafted, offering a unique take on the classic Redbreast style.

Key Points: 
  • NEW YORK, Sept. 12, 2024 /PRNewswire/ -- Redbreast, Ireland's most awarded single pot still whiskey* announced the release of its latest expression, Redbreast 18 Year Old.
  • This new member of the Redbreast family has been meticulously crafted, offering a unique take on the classic Redbreast style.
  • Redbreast 18 Year Old also includes whiskey aged in ruby port casks, as found in Redbreast 27 Year Old, creating rich flavors of autumnal fruits, toasted oak and nuttiness with a dusting of spices.
  • The resulting Redbreast 18 Year Old whiskey bursts with berry fruit aromas, toasted almond and cinnamon notes, hazelnut chocolate tones, and caramelized stone fruit sweetness.

OnX Unveils New Generative AI Accelerator Services Offering

Retrieved on: 
Thursday, September 12, 2024
Evaluation, Growth, AI, Microsoft Power Platform, Classification, Privacy, Workshop, Security, Microsoft Azure, Deployment, Azure, Workplace, AI accelerator, Microsoft

Comprehensive solution includes Copilot for Microsoft 365, which is fully activated through OnX's AI Accelerator services to drive successful adoption and business transformation.

Key Points: 
  • The solution capitalizes on OnX's AI Accelerator services, a suite of consulting and professional services offerings that securely integrates corporate information with generative AI's conversational intelligence to forge a new era of business operations.
  • OnX's AI Accelerator services deliver seamless, easy-to-deploy generative AI solutions that can harness the power of Copilot for Microsoft 365 as well as other solutions, such as Microsoft Fabric and Microsoft Azure AI.
  • Additional AI tools and platforms will be added to the AI Accelerator services portfolio in the coming months.
  • "We are thrilled to announce the launch of our new services focused on generative AI and large language models.

ZEISS Redefines Disease Management and Treatment within the ZEISS Retina Workflow

Retrieved on: 
Thursday, September 12, 2024
Patient, FDA, Ophthalmology, OCT, Carl Zeiss AG, Health, Artificial intelligence, Multimedia, IPhone, Pathfinder, Web browser, IPad, MDAX, Diagnosis, Classification, Anomaly, Surgeon, Quality of life, Carin, 3D, Head, Eye, TecDAX, Retinal, IOS, Workflow, VR, EVA, ULTRA, Optical coherence tomography, 2D, Deep learning, Documentation, DCA, Lens, Application, Microsurgery, UZ Leuven, Apple Inc.

JENA, Germany, Sept. 12, 2024 /PRNewswire/ -- ZEISS Medical Technology will showcase digital innovations and its latest 3D visualization technology as part of the ZEISS Retina Workflow at the European Society of Retina Specialists (EURETINA) conference. The new solutions within the ZEISS Medical Ecosystem help improve the diagnosis and treatment of retinal patients using the latest integrated, digital technologies.

Key Points: 
  • JENA, Germany, Sept. 12, 2024 /PRNewswire/ -- ZEISS Medical Technology will showcase digital innovations and its latest 3D visualization technology as part of the ZEISS Retina Workflow at the European Society of Retina Specialists (EURETINA) conference .
  • The new solutions within the ZEISS Medical Ecosystem help improve the diagnosis and treatment of retinal patients using the latest integrated, digital technologies.
  • Designed to complement the ZEISS Retina Workflow, CIRRUS PathFinder2 streamlines the review of large volumes of OCT data by identifying scans that may require closer review.
  • At EURETINA, ZEISS will also demonstrate a new product for ophthalmologists to review surgery videos pre-recorded with ZEISS surgical microscopes.

IceCure Announces FDA Advisory Panel Meeting Date for Marketing Authorization of ProSense® in Early-Stage Low Risk Breast Cancer Scheduled for November 7, 2024

Retrieved on: 
Thursday, September 12, 2024
De novo, Neoplasm, Patient, FDA, Food, Policy, Freezing, ICE3, Cryoablation, Recurrence, Woman, Breast cancer, Classification, Marketing, Pharmaceutical industry

The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense® for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.

Key Points: 
  • The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense® for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.
  • "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense® by early 2025."
  • The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community.
  • The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.

Auddia Inc. to Participate in the 2024 Gaming, Media & Entertainment Virtual Conference, Presented by Maxim Group LLC

Retrieved on: 
Thursday, September 12, 2024
Classification, CO, Conference, Radio, Executive, Radio receiver

BOULDER, CO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Auddia Inc. (NASDAQ:AUUD) (NASDAQ:AUUDW) (“Auddia” or the “Company”), a proprietary AI platform for audio identification and classification and related technologies, reinventing how consumers engage with AM/FM radio, podcasts, and other audio content, today announced that Executive Chairman Jeff Thramann has been invited to present at the 2024 Gaming, Media & Entertainment Virtual Conference, presented by Maxim Group LLC, on Tuesday, September 17th, 2024, at 11:00 a.m. E.T.

Key Points: 
  • BOULDER, CO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Auddia Inc. (NASDAQ:AUUD) (NASDAQ:AUUDW) (“Auddia” or the “Company”), a proprietary AI platform for audio identification and classification and related technologies, reinventing how consumers engage with AM/FM radio, podcasts, and other audio content, today announced that Executive Chairman Jeff Thramann has been invited to present at the 2024 Gaming, Media & Entertainment Virtual Conference, presented by Maxim Group LLC, on Tuesday, September 17th, 2024, at 11:00 a.m. E.T.
  • As the Gaming, Media & Entertainment industries continue to evolve, companies are navigating shifting consumer demand and global challenges.
  • The conference will explore how emerging growth companies are adapting to the current market environment and strategically positioning themselves for future success.
  • Maxim Senior Analysts will lead insightful discussions with CEOs and key management from a diverse array of companies, focusing on technology innovation and growth opportunities.

Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)

Retrieved on: 
Thursday, September 12, 2024
R2, Category B, High Impact, ICH, Risk assessment, Antioxidant, Category, Risk factor, Water, Question 2, Particle size, CHMP, Classification, FP, QWP, Quality control, Solubility, Regulation, Marketing, Hydrogen, MAH, Guideline, Solvent, CVMP, Regulation (European Union), Committee, Safety, Diluent, Monograph, Reproduction, Medication package insert, Veterinary medicine, Element, CQA, Directive, Q&A, European, EudraLex, Risk, EMA, Documentation, Royal college, FRA, Composition, Risk management, Excipient, Polymerization, Answer, Foundry

10 Keywords co-processed excipients, dossier requirements, risk categories 11 12 Introduction 13 While co-processed excipients (CoPEs) can offer benefits such as improved functionality, they also 14 introduce additional risks compared to using individual excipients.

Key Points: 
    • 10 Keywords co-processed excipients, dossier requirements, risk categories 11 12 Introduction 13 While co-processed excipients (CoPEs) can offer benefits such as improved functionality, they also 14 introduce additional risks compared to using individual excipients.
    • 19 These Q&As aim to harmonise and clarify dossier requirements for CoPEs using a risk-based approach; 20 the Q&As are applicable to human and veterinary solid oral dosage forms.
    • 36 A CoPE is not a novel excipient, nor a finished product intermediate without active substance, nor a 37 ?ready-to-use mixture? as referenced in EU Guidelines on excipients.
    • 40 The applicant/MAH needs to demonstrate that they have adequate understanding and control of the 41 finished product and its excipients.
    • 52 The applicant/MAH should identify which critical quality attributes (CQAs) of the finished product can 38 53 be impacted by the CoPE material attributes.
    • If the formulation includes other excipients with the 68 same function(s), impacting the CQAs, the risk linked to the CoPE may be lower.
    • The physico-chemical 70 characteristics of the CoPE, together with the proportion of the CoPE in the finished product, should all 71 be taken into consideration.
    • Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 3/13 103 3.
    • 113 EU guideline on manufacture of the finished dosage form (EMA/CHMP/QWP/245074/2015) and EU 114 guideline on Manufacture of the veterinary finished dosage form (EMA/CVMP/QWP/798401/2015).
    • Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 4/13 144 Description of the manufacturing process of the CoPE (3.2.P.4.
    • Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 6/13 221 ? Demonstration that a sufficiently homogenous CoPE quality (all relevant quality attributes) is 222 obtained throughout the entire process via appropriate process parameters and in-process 223 controls.
    • Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 7/13 233 Annex I: Risk factors and impact ranking table 234 Risk factors are interconnected and should not be considered in isolation.
    • Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 e.g.
    • 246 Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 10/13 247 248 249 250 251 Example on classification (Category B, Medium Risk) Pharmaceutical form: Hard capsules Composition of the finished product: Function Active substance CoPE (solubility enhancer) Surfactant Mineral carrier Diluent Disintegrant Lubricant Glidant 252 253 254 Amount 45% 2% 48% 4% 0.5% 0.5% Risk factor and impact ranking based on Annex I and Annex II.
    • 255 Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 11/13 256 257 258 259 260 Example on classification (Category C, Low Risk) Pharmaceutical form: film-coated tablet Composition of the finished product: Function Active substance CoPE (Filler) Filler Disintegrant Super disintegrant Filler Lubricant 261 262 263 Amount 15% 60% 5% 19% 1% Risk factor and impact ranking based on Annex I and Annex II.
    • 50%265 Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V) EMA/CHMP/CVMP/QWP/422493/2024 Page 13/13

Charm Peel Plate SA (Staphylococcus aureus) Microbial Test Receives AOAC-RI PTM SM Approval

Retrieved on: 
Wednesday, September 11, 2024
Certification, Business development, Regulatory affairs, Classification, Food, Water quality, PTM, Staphylococcus aureus, Bacteria, Peel, Enterotoxin, Staphylococcus, Food preservation

LAWRENCE, Mass., Sept. 11, 2024 /PRNewswire-PRWeb/ -- Charm Sciences, Inc. is pleased to announce that the Peel Plate® SA Microbial Test has received AOAC Research Institute Performance Tested Methods (PTMSM) certification 082401.

Key Points: 
  • LAWRENCE, Mass., Sept. 11, 2024 /PRNewswire-PRWeb/ -- Charm Sciences, Inc. is pleased to announce that the Peel Plate® SA Microbial Test has received AOAC Research Institute Performance Tested Methods (PTMSM) certification 082401.
  • Peel Plate bacterial tests are simplified culture methods developed for microbiologists, food, and water quality stakeholders.
  • Peel Plate SA Microbial Tests are easily interpreted with final results for Staphylococcus aureus in 24-48 hours with no secondary confirmation step such as DNase overlays required.
  • The technology of the Peel Plate SA Microbial Test is a dried medium in a shallow 47 mm plate that readily diffuses a liquid sample when added to the plate and no spreader device is needed.

New Study Reveals Generative AI Has Eclipsed Other AI Applications In the Enterprise Fueling a New Cohort of AI Leaders and Cloud Providers

Retrieved on: 
Wednesday, September 11, 2024
ALL, Cloud computing, Internet, Research, Classification, Telecommunications, GPU, Workforce, Government, Organization, S&P Global, Data management, Robotics, Smartphone, Transport, Health, WEKA, Aircraft, Carbon footprint, System, Synthetic media, Risk, Graphics processing unit, ChatGPT, Medical device

In less than two years, generative AI adoption has eclipsed all other AI applications in the enterprise, defining a new cohort of AI leaders and shaping an emergent market of specialty AI and GPU cloud providers," said John Abbott, principal research analyst at 451 Research, part of S&P Global Market Intelligence.

Key Points: 
  • In less than two years, generative AI adoption has eclipsed all other AI applications in the enterprise, defining a new cohort of AI leaders and shaping an emergent market of specialty AI and GPU cloud providers," said John Abbott, principal research analyst at 451 Research, part of S&P Global Market Intelligence.
  • "1
    Additionally, the new report underscored that, although AI is now more widely implemented in global organizations, obstacles remain in deploying AI successfully at scale.
  • Many organizations have successfully embraced AI infrastructure-as-a-service offerings from hyperscale cloud providers and an emergent market of new AI and GPU cloud markets to overcome this supply-demand gap and fuel their generative AI initiatives.
  • Generative AI adoption is exploding: 24% of organizations say they already see generative AI as an integrated capability deployed across their organization.

New Study Reveals Generative AI Has Eclipsed Other AI Applications In the Enterprise Fueling a New Cohort of AI Leaders and Cloud Providers

Retrieved on: 
Wednesday, September 11, 2024
ALL, Cloud computing, Internet, Research, Classification, Telecommunications, GPU, Workforce, Government, Organization, S&P Global, Data management, Robotics, Smartphone, Transport, Health, WEKA, Aircraft, Carbon footprint, System, Synthetic media, Risk, Graphics processing unit, ChatGPT, Medical device

In less than two years, generative AI adoption has eclipsed all other AI applications in the enterprise, defining a new cohort of AI leaders and shaping an emergent market of specialty AI and GPU cloud providers," said John Abbott, principal research analyst at 451 Research, part of S&P Global Market Intelligence.

Key Points: 
  • In less than two years, generative AI adoption has eclipsed all other AI applications in the enterprise, defining a new cohort of AI leaders and shaping an emergent market of specialty AI and GPU cloud providers," said John Abbott, principal research analyst at 451 Research, part of S&P Global Market Intelligence.
  • "1
    Additionally, the new report underscored that, although AI is now more widely implemented in global organizations, obstacles remain in deploying AI successfully at scale.
  • Many organizations have successfully embraced AI infrastructure-as-a-service offerings from hyperscale cloud providers and an emergent market of new AI and GPU cloud markets to overcome this supply-demand gap and fuel their generative AI initiatives.
  • Generative AI adoption is exploding: 24% of organizations say they already see generative AI as an integrated capability deployed across their organization.