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Medical Device Product Articles & Analysis
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Many medical devices are manufactured through plastic injection moulding, which allows for precise and top-quality components in large-scale production and better aligns with ISO standards. ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. ...
BySTEMart
These hydrogels are pivotal in medical devices, regenerative medicine, drug delivery systems, 3D cell culture, and wound healing." Diverse Product Offering: Biopharma PEG’s multi-arm PEG products are available with various branching structures and functional groups to meet the specific needs of researchers and developers in ...
These services are designed to help medical device manufacturers meet regulatory requirements and ensure the safety and effectiveness of their products. Medical device safety testing is a critical component of the product development process, ensuring that medical ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services for the medical device industry. ...
BySTEMart
Caresyntax, the leading vendor of enterprise-scale data-driven surgical intelligence solutions to make surgery safer and smarter, today announced its highlights and achievements of 2023, as the company has continued its strong growth journey. Dennis Kogan, co-founder, and CEO: “Caresyntax celebrated its 10-year anniversary in 2023 and accelerated our journey of innovation and expansion ...
This offering presents unparalleled opportunity for data enrichment and insight for medical device industry partners. “The ability to capture and deliver data insights across the entire cycle of care presents a new avenue for partners to measure value and improve outcomes with a data-first approach. ...
After a procedure, the Caresyntax platform provides insights that help surgeons benchmark and improve their care, hospital administrators use surgical resources more efficiently, medical device companies advance better products, and insurance companies understand risk and devise more tailored policies. ...
Caresyntax, the leading vendor-neutral enterprise surgical data and intelligence platform designed to make surgery smarter and safer by converging AI-powered software, devices, and clinical services, today announced a partnership with ARC (Accelerate, Redesign, Collaborate) Sheba’s Global Innovation platform to establish and replicate the ARC Surgical Innovation Model using ...
Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare ...
-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, pharmaceutical product, and consumer product industries using a variety of techniques under standard guidance. ...
BySTEMart
Generally speaking, the disinfection and sterilization packaging of medical devices refers to the initial packaging of the product, that is, the part that directly contacts the product and forms a microbial barrier. ...
Rob Chase is the founder and president of NewGen Surgical, a manufacturer of sustainably designed single-use disposable medical devices. He has over 25 years of experience in the medical device field, where he is helping to minimize the plastic waste generated in healthcare by reimagining single-use surgical ...
HINGHAM, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), which continues to build a reputation within the interventional radiology community for its LIBERTY® Robotic System, today announced the newest appointment to its Scientific Advisory Board (SAB), Sebastian Flacke, M.D. The addition of this thought leader adds a key robotic pioneer, who ...
NewGen Surgical, Inc. develops and manufactures sustainably designed, plant-based, single use medical devices and products. The company’s mission is to offer clinically effective product solutions to measurably reduce plastic and Scope 3 CO2 emissions. ...
Haggstrom brings an extensive background in medical device commercialization and product launches, with a technical background in R&D engineering, holding over 20 U.S. patents. ...
Amerigo Scientific provides high-quality and cost-effective medical device products worldwide to advance human health and address health emergencies. ...
Our company is founded on a mission to provide healthier product choices for healthcare.” It is estimated that plastics make up 85% of all medical equipment, and those purchased products carry embedded energy and carbon in their production, use and disposal – up to 71% of healthcare CO2 total. ...
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave IVL ...