Failure mode and effects analysis

Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023

Retrieved on: 
Thursday, November 2, 2023
B-cell lymphoma, Rheumatoid arthritis, Mantle cell lymphoma, Symantec Endpoint Protection, Ulcerative colitis, Pulmonary embolism, Lupus, CET, Infection, SLE, RT, Bleeding, ORR, Safety, Patient, TYK2, Baltic, DLBCL, CR, Euronext, Galapagos NV, Failure mode and effects analysis, ASH, UK, Follicular lymphoma, Letter, CRS, Non-Hodgkin lymphoma, Survival, ET, Technology transfer, CRR, UC, CD19, Indolent lymphoma, CFO, Burn, Lymphoid leukemia, Pharmaceutical industry, Cryptocurrency, Vaccine, Uranium mining, Pamlab, Galápagos Islands, Dermatomyositis, Central Europe

Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).

Key Points: 
  • Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).
  • Overall, 11 of 13 patients responded to treatment (ORR of 85%) and 9 of 13 patients achieved a CRR (69%).
  • New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and poster presentation details below).
  • New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled in ATALANTA-1 will be presented at ASH (see ASH abstract and poster presentation details below).

Telesair Receives FDA Clearance for Bonhawa High Flow Oxygen Therapy System

Retrieved on: 
Tuesday, October 17, 2023
Technology, Research, Medical Devices, FDA, Other Technology, Health Technology, Health, General Health, Science, Hospital, Doctor of Philosophy, Long-term care, CE, Failure mode and effects analysis, Ventilation, Patient, Medical device

Telesair, Inc. , a technology leader in the respiratory industry, announced today that it has received FDA clearance to market its Bonhawa High Flow Oxygen Therapy (HFOT) system, designed to enhance the treatment of patients with respiratory insufficiency.

Key Points: 
  • Telesair, Inc. , a technology leader in the respiratory industry, announced today that it has received FDA clearance to market its Bonhawa High Flow Oxygen Therapy (HFOT) system, designed to enhance the treatment of patients with respiratory insufficiency.
  • Bonhawa is now the only purpose-built high flow system to receive both the CE Mark/European Medical Device Regulation and FDA 510(k) clearance.
  • “The best in class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians,” said Bryan Liu, PhD, CEO of Telesair.
  • Bonhawa is the only standalone high flow oxygen therapy system designed by experts in ventilation.

Protecting Through Technical Expertise: SQA Services, Inc. Introduces White Paper on PFMEA Methodology

Retrieved on: 
Thursday, October 5, 2023
PFMEA, Production part approval process, Failure mode and effects analysis, SQA, Program management, Certified Quality Engineer, PPAP, Retail, Risk management, Engineering

PFMEA is a powerful tool used to evaluate and enhance processes across industries, offering a roadmap to improved quality, efficiency, and cost-effectiveness.

Key Points: 
  • PFMEA is a powerful tool used to evaluate and enhance processes across industries, offering a roadmap to improved quality, efficiency, and cost-effectiveness.
  • SQA Services, Inc. exemplifies the effectiveness of PFMEA in a case involving a commercial aircraft manufacturer.
  • By implementing PFMEA, SQA helped the client address recurring defects linked to a key supplier's variability, ultimately saving millions of dollars in rework and scrap.
  • To access the complete white paper and learn more about how PFMEA can enhance your business processes, visit the SQA Website .

MathWorks Introduces Simulink Fault Analyzer and Polyspace Test in MATLAB and Simulink Release 2023b

Retrieved on: 
Thursday, September 21, 2023
Software, Professional Services, Electronic Design Automation, Data Management, Technology, 5G, Satellite, Data Analytics, Engineering, Aerospace, Manufacturing, Telecommunications, MATLAB, Communication, C, Toolbox, Failure mode and effects analysis, WLAN, Computer, MathWorks, FMEA, OFDM, Polyspace, Socs, Logic, LOS, AI, Field-programmable gate array, Artifact, Wireless, Video game, Inspection, Communications satellite, Medical device, Application-specific integrated circuit, Simulink, Linux

MathWorks unveiled Release 2023b (R2023b) of the MATLAB® and Simulink® product families today.

Key Points: 
  • MathWorks unveiled Release 2023b (R2023b) of the MATLAB® and Simulink® product families today.
  • Simulink Fault Analyzer™ enables systematic fault effect and safety analysis using simulation.
  • Simulink Fault Analyzer helps engineers create and document formal connections between faults, hazards, fault detection and mitigation logic, and other artifacts when paired with Requirements Toolbox ™.
  • For information on all the new products, enhancements, and bug fixes to the MATLAB and Simulink product families, visit https://www.mathworks.com/products/new_products/latest_features.html .

Krystal Biotech Announces Orphan Drug Designation Granted to KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency

Retrieved on: 
Tuesday, September 5, 2023
KRYS, Research and development, Failure mode and effects analysis, Suma, SERPINA1, AATD, Patient, Liver, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry

KB408 IND filed on August 15, 2023

Key Points: 
  • KB408 IND filed on August 15, 2023
    PITTSBURGH, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD).
  • AATD is caused by mutations in the SERPINA1 gene that lead to decreased levels and/or decreased functionality of alpha-1 antitrypsin protein.
  • Over time, the deficiency can lead to progressive enzymatic destruction of the lung tissue, ultimately causing life-threatening pulmonary impairment and severe respiratory insufficiency.
  • KB408 is an inhaled (nebulized) formulation of the Company’s novel replication-defective, non-integrating HSV-1-based vector designed to deliver two copies of the SERPINA1 transgene, that encodes for human alpha-1 antitrypsin protein, for the treatment of AATD.

Telesair Receives CE Mark for Bonhawa High Flow Oxygen Therapy System

Retrieved on: 
Tuesday, August 22, 2023
Medical Devices, Hospitals, Health, Health Technology, Nursing, Failure mode and effects analysis, CE marking, Long-term care, Light, Hospital, Patient, Disinfectant, Workload, European Medical Students' Association, Caregiver, Medical device

Telesair, Inc. , an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European Medical Device Regulation for its Bonhawa High Flow Oxygen Therapy (HFOT) system for use in the treatment of patients with respiratory insufficiency.

Key Points: 
  • Telesair, Inc. , an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European Medical Device Regulation for its Bonhawa High Flow Oxygen Therapy (HFOT) system for use in the treatment of patients with respiratory insufficiency.
  • “Having our Bonhawa system approved for Europe is a major step in the evolution of Telesair as a company and opens the many markets which accept CE Mark,” said Bryan Liu, CEO of Telesair.
  • Telesair’s CE Mark and introduction of its lightweight oxygen therapy system to Europe further expands the company’s existing market access that includes Latin America and Southeast Asia.
  • Telesair’s solutions are designed to elevate the existing standard of care by improving outcomes for patients and the health system.

Telesair’s Bonhawa High Flow Oxygen Receives Approval from Thai FDA

Retrieved on: 
Tuesday, August 15, 2023
Medical Devices, Health, Learning, Failure mode and effects analysis, JPP, Long-term care, Light, Hospital, Patient, Disinfectant, Medical device

Telesair, Inc. , an innovator of next-generation respiratory care, and JPP Care , a leading Thai distributor of respiratory devices, jointly announced today that Telesair’s Bonhawa High Flow Oxygen Therapy (HFOT) system has been approved by Thailand’s Food and Drug Administration (Thai FDA) for use in the treatment of patients with respiratory insufficiency.

Key Points: 
  • Telesair, Inc. , an innovator of next-generation respiratory care, and JPP Care , a leading Thai distributor of respiratory devices, jointly announced today that Telesair’s Bonhawa High Flow Oxygen Therapy (HFOT) system has been approved by Thailand’s Food and Drug Administration (Thai FDA) for use in the treatment of patients with respiratory insufficiency.
  • “Thailand is an important market for us,” said Bryan Liu, CEO of Telesair.
  • “High flow oxygen therapy has become widely accepted at Thai medical centers of excellence and there are many clinicians there that we are eager to work with.
  • “This latest success was truly a team effort and with our Bonhawa HFOT system now available in Thailand, we’re just getting started,” added Liu.

FDA Clears ReddyPort® Non-Invasive Ventilation Device

Retrieved on: 
Tuesday, July 18, 2023
NIV, COPD, Elbow, Joint Commission, Failure, Failure mode and effects analysis, Xerostomia, Patient, Mask, Risk, ICU, Lung compliance, Yankauer suction tip, Mouth, Caregiver, Dentistry

"ReddyPort's patented elbow is central to the eco-system we are building to help mitigate clinical obstacles tied to NIV therapy from dry-mouth, oral biofilm accumulation to speech recognition," says Tony Lair, ReddyPort CEO.

Key Points: 
  • "ReddyPort's patented elbow is central to the eco-system we are building to help mitigate clinical obstacles tied to NIV therapy from dry-mouth, oral biofilm accumulation to speech recognition," says Tony Lair, ReddyPort CEO.
  • ReddyPort's elbow features a self-sealing valve that provides seamless oral access to the patient's mouth without the need for mask removal, alleviating the risk of therapeutic pressure loss and maintaining lung compliance.
  • The ReddyPort microphone amplifies audible speech tones while minimizing background noise, helping patients to regain their ability to effectively communicate with caregivers and family members.
  • The ReddyPort System, with the ReddyPort elbow at its core, promotes NIV success by empowering clinicians with efficient access to provide oral care without removing the mask or loss of therapeutic pressures.

Global Organ Preservation Market Report 2023: Advancements in Medical Technology Bolsters Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, June 19, 2023
Other Health, General Health, Pharmaceutical, Medical Devices, Hospitals, Health Technology, Surgery, Cardiology, Biotechnology, Stem Cells, Medical Supplies, Health, HTK, Failure mode and effects analysis, Heart, BMC, Surgeon, Travel, Society, UW, Prevalence, Diabetes, Society of Critical Care Medicine, Statistics, Vascular resistance, Kidney failure, Brihanmumbai Municipal Corporation, Meal, Glomerular filtration rate, Multiple organ dysfunction syndrome, Research, MEA, USD, Sepsis, Intensive care medicine, INR, Incidence, Hospital, Patient, Tuberculosis, Organ transplantation, Plant growth analysis, Organ, Liver, Mortality, Cirrhosis, Transport, Intensive care unit, Pelvic floor dysfunction, Critical Care Medicine (journal), Dentistry, Pharmaceutical industry, Medical device

The "Global Organ Preservation Market Size, Share, Growth Analysis, By Solutions, By Technique, By Organ, By End User - Industry Forecast 2022-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Organ Preservation Market Size, Share, Growth Analysis, By Solutions, By Technique, By Organ, By End User - Industry Forecast 2022-2028" report has been added to ResearchAndMarkets.com's offering.
  • The global organ preservation market is witnessing steady growth due to advancements in medical technology.
  • Based on the solution, the global organ preservation market is segmented into UW, custodial HTK, and perfadex.
  • Based on the organ, the global organ preservation market is segmented into kidneys, liver, and heart.

Amylyx Pharmaceuticals Completes Negotiation Process and Signs Letter of Intent with the pCPA for ALBRIOZA™ for the Treatment of ALS

Retrieved on: 
Thursday, June 15, 2023
Professional Services, Health, Neurology, Finance, General Health, Pharmaceutical, ALS Society of Canada, Letter of intent, PCPA, Spinal cord, Clinical trial, Pan-Canadian Pharmaceutical Alliance, Brain, Life expectancy, Translation, Medication, LOI, Montreal Neurological Institute and Hospital, Failure mode and effects analysis, Health Canada, ALS, News, Caregiver, Disease, Health insurance, Pharmaceutical industry, Amylyx Pharmaceuticals

“Today marks a major milestone for people living with ALS and their caregivers in Canada.

Key Points: 
  • “Today marks a major milestone for people living with ALS and their caregivers in Canada.
  • Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually death.
  • ALBRIOZA received approval with conditions from Health Canada in June 2022, marking the first regulatory approval for ALBRIOZA issued to Amylyx worldwide.
  • We believe there are opportunities to streamline the multiple steps and lengthy processes involved in achieving public reimbursement for treatments like ALBRIOZA in Canada.