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Medical Devices And Combination Products Articles & Analysis: Older
68 news found
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. In general, injection moulding for medical devices is conducted in an ISO 8 clean room environment to ensure all products adhere to the strictest standards of sterility and safety.This article covers how ...
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 market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...
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. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...
BySTEMart
Biopharma PEG, a leader in PEG derivatives, is excited to announce the expansion of its high-purity Multi-Arm PEG linker product line, catering to the evolving needs of the medical and bioorganic fields. These advanced PEG linkers are available in various functional groups and molecular weights ranging from 1k to 40k, offering unmatched versatility and performance for research and development in ...
Protheragen-ING Lab, a well-known and reputable Good Laboratory Practices (GLP) service provider, has recently unveiled its cutting-edge medical device services. With a track record of excellence and reliability in providing high-quality services to the pharmaceutical and biotechnology industries, Protheragen-ING Lab is now expanding its offerings to include comprehensive solutions for 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. These services allow manufacturers to test and refine their products prior to full-scale production, streamlining the development process of new medical devices and minimizing risk to save time ...
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 ...
Caresyntax, the leading vendor-neutral surgical data and intelligence platform converging AI-powered software, devices, and clinical services, today announced the launch of Caresyntax Clinical Data as a Service (CDaaS) for Medtech industry partners. The launch of Caresyntax CDaaS follows the recently announced addition of CQInsights (CQI) and appointment of Dr. Bruce Ramshaw as Chief Medical ...
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 the Caresyntax ...
The U.S. 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 facilities where non-critical medical devices are present. ...
-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
Disinfection and sterilization packaging can be divided into two parts: primary packaging and auxiliary packaging. 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. Auxiliary packaging mainly involves the storage and circulation of ...
McKinsey’s Values and Value event series convenes ESG leaders from across the Life Sciences industry to discuss the hot topics, questions, wins, and challenges that arise on the path to improving the industry’s environmental and social impact. During the session, Rob Chase, Founder and President of NewGen Surgical, and Samantha Smith, Director at Medtronic’s Sustainability ...
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 has a history of ...
NewGen Surgical Inc. announced today that it has earned the U.S. Department of Agriculture (USDA) Certified Biobased Product label on all product lines. Managed by the U.S. Department of Agriculture (USDA), the BioPreferred Program is an initiative created by the 2002 Farm Bill (and recently reauthorized by the 2018 Farm Bill), to increase the development, purchase, and use of biobased products. ...
Synchron, an endovascular brain-computer (BCI) interface company, today announced the appointment of Kurt Haggstrom as Chief Commercial Officer. 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. “I am honored and excited to join the Synchron team and be part of ...
Amerigo Scientific provides high-quality and cost-effective medical device products worldwide to advance human health and address health emergencies. ...
Surgical has signed the Department of Health and Human Services (HHS) climate pledge initiative NewGen in partnership with the White House to mobilize the healthcare sector to reduce carbon emissions. On April 22, 2022, the HHS issued a call to action for healthcare stakeholders to commit to tackling the climate crisis through a new initiative aimed at reducing emissions across the healthcare ...
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 System with the Shockwave C2 Coronary IVL Catheters ...