drug device Articles
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Risk information in prescription drug & medical device ads, promotional labeling – What the FDA expects
Abstract: The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices. This article gives an overview and summary of the ...
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Nitrogen Dioxide Sterilization: Maintains Prefilled Syringe Integrity
Noxilizer has developed an optimal sterilization process specifically for prefilled syringes and other drug-delivery devices. The low temperature NO2sterilization process will effectively sterilize the external, gas accessible surfaces of the syringewith minimal to no impact on the contents of the syringe. The process is carried out between 10°C and 30°C, without the need for a deep ...
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A better auto-injector with Covestro polycarbonate
Auto-injectors, drug delivery medical devices that automatically administer an injectable dose for a patient, have grown in popularity over the past decade. This is in part due to their ability to simplify self-administration, improve safety and encourage compliance for patients. Unfortunately, many patients still experience anxiety associated with affordability, portability and usability when ...
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Sustainability considerations for end-to-end drug delivery device solutions
In this article, Barbara Lead, Chief Executive Officer of Cambridge Pharma and Oval Medical Technologies, outlines the sustainability efforts undertaken by SMC Group associated companies, including facilitating the transition from hospital to at-home treatment and investment in greener facilities. At the 2021 COP26 summit in Glasgow, further cuts to carbon dioxide emissions were agreed to ...
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Dyve Biosciences enrolls first patient in gout trial
Dyve Biosciences announced today that it enrolled its first patient in the Phase 2 clinical study of its DYV-700 topically administered therapeutic for acute gout treatment. Thousand Oaks, Calif.–based Dyve won FDA clearance to begin the Targets Phase 2 trial in December 2019. The double-blind, placebo-controlled, randomized clinical trial is set to evaluate the efficacy of DYV-700 in ...
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What is GMP?
Hundreds of millions of Americans rely on life-saving and sustaining medications and medical devices every day. Ensuring the drugs and devices that they depend on are not contaminated is critical for the health of the country, and the responsibility of the U.S. Food and Drug Administration (FDA). To address safety concerns in the medical, pharmaceutical, and food industries, the FDA ...
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Are you compliant with the Sunshine Act?
Section 6002 of the Affordable Care Act (ACA) of 2010 – also known as the Physician Payments Sunshine Act (PPSA) – requires all manufacturers of drugs, medical devices and biologicals that participate in US federal healthcare programs to disclose any and all payments or other transfers of value made to physicians or teaching hospitals. It also requires disclosure of any physician ...
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Alucent Biomedical Re-Envisioning PAD Treatment with a Natural Vascular Scaffold
Start-up Alucent Biomedical is using a light-activated molecule, delivered via a balloon catheter, to create a natural vascular scaffold in diseased peripheral vessels, with the aim of providing a long-lasting treatment option that maintains patency while leaving nothing behind in the vessel. Alucent Biomedical Inc. is rethinking peripheral artery disease (PAD) treatment with a novel natural ...
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Impact of Healthcare Industry in India
The Healthcare industry is one of India’s rapidly growing and largest sectors contributing approximately 60% of the industry’s total revenue. A wide range of employability and startup innovations associated with the revenue developed to drive the industry. It comprises of hospitals, medical devices, telemedicine, clinical trials, medical equipment, integration of health insurance and ...
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Bio-Ink: Printing the Future of Medicine and Beyond
Bio-ink is a revolutionary material that is rapidly changing the fields of medicine, tissue engineering, and even bioprinting food. This fascinating substance is essentially a type of ink made from living cells and other biocompatible materials that can be used to 3D print complex biological structures. What is Bio-Ink Made Of? The composition of bio-ink can vary depending on the desired ...
By Matexcel
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How Proper Packaging Improves the Shelf Life of Medical Devices
Medical devices are incredibly important in today’s world. They play a significant role in the treatment and prevention of various medical conditions. However, their effectiveness can be compromised if they are not packaged correctly. Packaging is an essential component of maintaining the integrity and shelf life of medical devices, especially during transportation and storage. Read on ...
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Exploring the Origins and Categorization of Microneedles
Microneedles (MN) is a new type of physical permeability-enhancing technology. It consists of multiple micron-scale fine needle tips connected to the base in an array. The needle body is generally 10-2000 microns high and 10-50 microns wide. The length, size and shape of the microneedles can be individually designed according to the needs of the application. When the microneedle delivers the ...
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Everything we know About AMD and Dark Adaptation
When automated dark adaptometry was first commercialized, many of us had more questions than answers with regard to using this information for detecting AMD and monitoring disease progression. But with more than seven years of practical in-office experience performing dark adaptation testing on thousands of patients, the tables have turned. This technology offers a safety net for ...
By MacuLogix
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Field Orthopaedics gets FDA approval for world’s smallest orthopaedic screw
The Brisbane-based designer of the world’s smallest orthopaedic screw has invoiced US hospital suppliers $900,000 in the three weeks since the device gained Food & Drug Administration approval, and he hopes it can soon be made in Brisbane too. Field Orthopaedics, founded in 2016 by former Army doctor Chris Jeffery alongside a team of doctors and engineers including hand surgeon Greg ...
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Silica-based nanoporous sol-gel glasses: from bioencapsulation to protein folding studies
Organic-inorganic nanoporous silica sol-gel glasses constitute the ideal support for protein bio-encapsulation and to study the different factors influencing the protein folding process in a crowded environment. Due to the facile silica surface modifications with desired Si-substituted organic groups from organosilanes precursors, organically modified 'wet-aged' silica-based glasses obtained via ...
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VCs infuse $215M into Sanofi-backed wearable subcutaneous drug delivery player Enable Injections
Sanofi-backed Enable Injections has gone big with its series C round. Three years after Sanofi led its series B, Enable Injections has raised a $215 million round to fund work on subcutaneous drug delivery system enFuse. Enable Injections’ device consists of a wearable delivery disc and a system for transferring the drug from its original vessel. Users put the disc in the transfer ...
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Needlestick Injury - the pointy end of a preventable pandemic
The Challenge Every 60 minutes, of every day, six people suffer a needlestick injury somewhere in the world. Every day, 3 people die as a result of those injuries[1]. The World Health Organisation (WHO) reports in the World Health Report 2002, that of the 35 million health-care workers world wide, two million experience percutaneous exposure to infectious diseases each year[2]. WHO estimates ...
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Mojo Vision teams up with optics leader Menicon to develop AR contact lenses
Mojo Vision has developed prototypes for contact lenses that enable people to see augmented reality images as overlays on the real world. And now it has teamed up with Menicon, Japan’s largest and oldest maker of contact lenses, to further develop the product. Saratoga, California-based Mojo Vision has developed a smart contact lens with a tiny built-in display that lets you view augmented ...
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Want to Control Bacteria Growth? Control Moisture
We’ve all crinkled our noses when we’ve caught a whiff of wet clothes that sat in the clothes hamper too long. They smell bad. Our noses are warning us that bacteria are growing in those smelly clothes - and some types of bacteria can be bad for us. Bacteria in Healthcare Settings Bacteria in healthcare settings may not just be smelly. Some types of bacteria can ...
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Unveiling Mysteries of Hydrophobic Polymers, Photochromic Materials, PVC Stabilizers, and Biocompatible Ceramics
In the field of materials science, there are various fascinating areas that have captured the attention of researchers and innovators worldwide. This article aims to shed light on four such intriguing topics: Hydrophobic Polymers, Photochromic Materials, PVC Stabilizers, and Biocompatible Ceramics. By delving into the mysteries surrounding these subjects, we can gain a deeper understanding of ...
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