Sterilization

SS Innovations Appoints Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs

Retrieved on: 
Monday, October 30, 2023
Class II, AAMI, Product lifecycle, Johns Hopkins University, SS, Johnson & Johnson, Digital Solutions, Robotics, University, OTC, Johns, Organization, American Society for Microbiology, Society, Mantra, BSI, BSI Group, Partnership, Head, Stroke, Sterilization, Quality function deployment, Quality, SSI, Medtronic, Ethylene oxide, Pharmaceutical industry, Medical device, MD

FORT LAUDERDALE, FL, Oct. 30, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announces the appointment of Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs.

Key Points: 
  • Dr. Shokeen will lead SS Innovations’ Product Lifecycle Management, Quality System Management, regulatory strategy, and international submissions.
  • Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, said, “Dr.
  • Shokeen brings a wealth of experience to this role, and I am delighted to welcome her to the SS Innovations team.
  • Prior to joining SS Innovations, Dr. Shokeen led Quality Function in senior management roles at Johnson and Johnson (Auris Health) in its Robotics and Digital Solutions franchise in Redwood City, CA.

BellaSeno Presents Novel Production Workflow for Customized, 3D-Printed Bone Scaffolds

Retrieved on: 
Monday, October 30, 2023
FDM, Medical device regulation, Medtech, MDR, Bone, Injury, CT, Workflow, Orthopedic surgery, ISO, Sterilization, 3D printing, Medical device, Traumatology

The presentation titled "Semi-automated workflow for the design and fabrication of 3D-printed patient-specific resorbable scaffolds for the treatment of large segmental bone defects while complying with MDR regulations" outlined the potential of BellaSeno´s novel resorbable scaffolds for curing large segmental bone defects (> 5cm size).

Key Points: 
  • The presentation titled "Semi-automated workflow for the design and fabrication of 3D-printed patient-specific resorbable scaffolds for the treatment of large segmental bone defects while complying with MDR regulations" outlined the potential of BellaSeno´s novel resorbable scaffolds for curing large segmental bone defects (> 5cm size).
  • The scaffold is needed to hold the autologous bone graft in position for optimal vascularization and bone healing.
  • Scaffolds made by additive manufacturing from bioresorbable polymers represents a highly attractive opportunity to produce such patient-specific open-pore scaffolds.
  • This results in a new generation of high-performance bone scaffolds which are well suited for the biological reconstruction of large bone defects."

Neglected Bee Hotels Pose a Threat to Mason Bee Populations: A Fall Cleaning Initiative

Retrieved on: 
Thursday, November 2, 2023
Bee, University of California, Davis, Pollen, Parasitism, UC, Maintenance, Harry Houdini, Honey, Risk, MITES, Sterilization

While millions of bee hotels are purchased each year, many lack the required care and maintenance, jeopardizing bee health.

Key Points: 
  • While millions of bee hotels are purchased each year, many lack the required care and maintenance, jeopardizing bee health.
  • Researchers and industry leaders have observed a rise in predators and parasites, posing a significant threat to mason bee populations.
  • Failing to address this issue could result in bee hotels becoming infested by these predators, endangering mason bee populations.
  • She points out, "Houdini flies and pollen mites are prevalent parasites we encounter in mason bee hotels.

FDA Roundup: October 31, 2023

Retrieved on: 
Tuesday, October 31, 2023
Cream, Ice cream, FDA, Steris, Food, Ethylene oxide, Vaccine, Listeria monocytogenes, Cisplatin, Human services, Infection, News, Medical device, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PMA, HIV disease progression rates, Cosmetics, NPC, Soft serve, Multimedia, Dietary supplement, Environment, Nasopharyngeal carcinoma, Disease, Radiation, EO, Sterilization, Public, House, Woman, Safety, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Office of Inspector General, U.S. Department of Health and Human Services, Patient, Heated tobacco product, China Biologic Products, Animal, Essure

The FDA remains committed to collecting and providing updates on the long-term safety and effectiveness information about Essure, a permanently implanted birth control device for women.

Key Points: 
  • The FDA remains committed to collecting and providing updates on the long-term safety and effectiveness information about Essure, a permanently implanted birth control device for women.
  • Although Essure has not been available for implantation in the United States since December 2019, the FDA continues to monitor the product's safety through an FDA-required postmarket surveillance ("522") study and other activities.
  • The master file was submitted by Steris Corporation, Sterilization for Medical Devices | FDA .
  • The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

ClorDiSys Expands Chlorine Dioxide Gas Medical Device Sterilization into Europe

Retrieved on: 
Monday, October 30, 2023
Universe, Temperature, Medical device, United States Environmental Protection Agency, Conference, Chlorine, Disinfectant, Multimedia, Ethylene oxide, PDA, EPA, Syringe, Johnson & Johnson, Safety, Sterilization, Sewage treatment

BRANCHBURG, N.J., Oct. 30, 2023 /PRNewswire/ -- ClorDiSys Solutions, Inc., headquartered in Branchburg, NJ, officially expands its presence in Europe for its chlorine dioxide gas technology for Medical Device sterilization at the PDA Universe of Pre-filled Syringes and Injection Devices Conference in Gothenburg, Sweden.

Key Points: 
  • BRANCHBURG, N.J., Oct. 30, 2023 /PRNewswire/ -- ClorDiSys Solutions, Inc., headquartered in Branchburg, NJ, officially expands its presence in Europe for its chlorine dioxide gas technology for Medical Device sterilization at the PDA Universe of Pre-filled Syringes and Injection Devices Conference in Gothenburg, Sweden.
  • ClorDiSys' chlorine dioxide gas is non-carcinogenic, non-explosive, and is a United States Environmental Protection Agency (EPA) registered sterilant.
  • Chlorine dioxide vacuum pressure sterilizers allow for the option of the sterilization of complex designed devices within bulk packaging, as well as a vast reduction in cycle time and complexity of the chlorine dioxide gas sterilization process.
  • ClorDiSys developed its technology through Johnson and Johnson, and chlorine dioxide gas has been providing true sterilization for medical devices for over 25 years.

NAM aspires to be leader in manufacturing, import and distribution of medical instruments and sterile medical equipment in Thailand

Retrieved on: 
Tuesday, October 31, 2023
Knowledge, IPO, Final good, NAM, SET, Stock exchange, Government, Corporate finance, Data collection, Research, Disinfectant, Engineering, Software, Nursing, PTT Public Company Limited, Growth, Risk, Hospital, Chemistry, Sterilization, Decontamination, Security (finance), Medical device

The Company aspires to become a leader in the manufacturing, import, and distribution of medical instruments and sterile medical equipment in Thailand.

Key Points: 
  • The Company aspires to become a leader in the manufacturing, import, and distribution of medical instruments and sterile medical equipment in Thailand.
  • Therefore, it is extremely important to heighten medical standards because the process to reduce the risk of contamination from outside is crucial.
  • is an important step that will help drive NAM to grow into a world-class medical instrument and equipment brand.
  • This fact should allow investors and shareholders to see the potential of the Company?s becoming a leader in the manufacturing and distribution of sterile medical instruments and equipment in Thailand while being ready to build on sustainable strength.

ClariMed Company, UserWise, Expands Capabilities and Capacity in San Jose

Retrieved on: 
Thursday, October 26, 2023
O Clarim, Medtech, Safety, Sterilization, Disinfectant, Observation, Medical device

UserWise, a ClariMed company, opens new state-of-the-art offices and study viewing facilities in San Jose, California.

Key Points: 
  • UserWise, a ClariMed company, opens new state-of-the-art offices and study viewing facilities in San Jose, California.
  • The new facility boasts an impressive approximate 10,000 square feet with three advanced study observation rooms equipped with one-way mirrors and enhanced screen monitoring/capture capabilities.
  • Kelley Kendle, CEO of ClariMed, added, "The new state-of-the-art facility in San Jose is more than just an office; it's a bold statement of intent.
  • The new office location is 10 Almaden Blvd., in San Jose, California.

ClariMed Company, UserWise, Expands Capabilities and Capacity in San Jose

Retrieved on: 
Thursday, October 26, 2023
O Clarim, Medtech, Safety, Sterilization, Disinfectant, Observation, Medical device

The new facility boasts an impressive approximate 10,000 square feet with three advanced study observation rooms equipped with one-way mirrors and enhanced screen monitoring/capture capabilities.

Key Points: 
  • The new facility boasts an impressive approximate 10,000 square feet with three advanced study observation rooms equipped with one-way mirrors and enhanced screen monitoring/capture capabilities.
  • Kelley Kendle, CEO of ClariMed, added, "The new state-of-the-art facility in San Jose is more than just an office; it's a bold statement of intent.
  • This extended capacity the space offers not only positions ClariMed for exponential growth but also stands as a tangible testament to our aggressive expansion strategy.
  • The new office location is 10 Almaden Blvd., in San Jose, California.

LIGHTTALK Unveils LightQueen, a UVC+ Plasma Toilet Seat Sterilizer

Retrieved on: 
Wednesday, October 25, 2023
Consumer Electronics, Technology, Manufacturing, Other Health, Health, Other Manufacturing, Infectious Diseases, Retail, Home Goods, COVID-19, Hardware, WHO, UVC, Urinal deodorizer block, Plasma, Escherichia coli, Virus, Research, Urine, World Health Organization, Risk, Messenger, Feces, Hygiene, Sterilization, Infection, Sewage treatment

LIGHTTALK, a startup established in Gwangmyeong, South Korea, sells and rents the LightQueen UVC+plasma toilet seat sterilizer.

Key Points: 
  • LIGHTTALK, a startup established in Gwangmyeong, South Korea, sells and rents the LightQueen UVC+plasma toilet seat sterilizer.
  • When LightQueen, a rotating UVC plasma toilet seat sterilizer, is attached to the toilet cover and closed, it turns 90 degrees to move to the center of the toilet and uses UVC ultraviolet rays to sanitize the toilet seat and the inside of the toilet.
  • The product employs a safe plasma module developed by Plabank Co., Ltd which has 40 years of plasma research expertise.
  • Test analysis has shown LightQueen’s plasma has reduced E. coli by 93.7% and eliminate 99.1% of mRNA floating viruses.

Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market, 2035 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 24, 2023
Health, Pharmaceutical, Type, Elastomer, FDA, Biomedical Advanced Research and Development Authority, AptarGroup, Vaccine, Container, SCHOTT, Dätwyler, West Pharmaceutical Services, Glass, BARDA, Development, Growth, COVID-19, RTU, Duran (glass), EMA, Porta Nuova (Milan), Safety, Material, EZ, Investment, Syringe, Value proposition, Patient safety, Sterilization, Medical device, Fine chemical, Borosilicate glass, Stevanato Group

This focus on product safety has given rise to the adoption of pre-sterilized or ready-to-use containers and closures in pharmaceutical packaging.

Key Points: 
  • This focus on product safety has given rise to the adoption of pre-sterilized or ready-to-use containers and closures in pharmaceutical packaging.
  • It's essential to highlight that the growing demand for secure drug delivery systems has fueled the expansion of the global pharmaceutical packaging market.
  • The integration of ready-to-use (RTU) packaging containers in the pharmaceutical sector enables expedited product launches through an optimized value chain.
  • The current landscape of pre-sterilized / ready to use pharmaceutical primary packaging features close to 95 RTU containers and 85 RTU closures.