By Mike Hollan The platform utilizes standards set forth in a recently published document from the CDC. After years of collaborating with hospitals, Magnolia Medical has launched a new digital platform designed to prevent sepsis misdiagnosis.1 The platform, Magnolia Analytics, was designed with the CDC’s recently published Blood Culture Contamination guidelines in mind. The main addition to the guidelines is a new step utilizing initial specimen diversion devices, which Magnolia specializes in. CDC notes that reducing sepsis misdiagnosis is important as it can play a key role in reducing the amount of needlessly prescribed antibiotics, which can then further play a role in reducing instances of antibiotic resistance. In a press release, Magnolia Medical co-founder and CEO Greg Bullington said, “In response to our customer’s clear unmet needs, we developed Magnolia Analytics as a custom, exclusive solution to support our hospitals in achieving and sustaining their blood culture contamination rates ...
Drugdu.com expert’s response: The registration process for Class III medical devices in Russia typically requires a period of 24 months or more. Based on official requirements and information from reference articles, here is a detailed explanation and summary of the registration timeline: Medical Device Classification: According to the Russian medical device classification standards, Class III medical devices fall into the high-risk category, requiring a more stringent registration and review process. Registration Process: The registration process includes appointing a Russian authorized representative, product classification identification, submitting technical documentation for medical devices, conducting system audits (if applicable), and undergoing RZN evaluation. Registration Timeline: Initial Review: Once the application materials are complete, the registration agency will submit the application to the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor). The initial review may take several weeks to several months to confirm the completeness and compliance of the application documents. Detailed Review and Evaluation: ...
Parkinson’s UK has awarded nearly £100,000 to researchers at Imperial College London (ICL) to develop a new drug for Parkinson’s disease (PD) through the charity’s drug accelerator award grant scheme. Researchers will use a computer-based programme to simulate good targets for new drugs to slow the progression of the neurological disease and improve the success of clinical trials. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. In the process of drug development, the more information that researchers have when planning a clinical trial, including simulating how a drug might work, the more likely it is to be successful when being trialled in people and compared to other available treatments. Using simulation, researchers aim to test the best way to target GPNMB, a protein that has been linked to PD. Previous ...
A study conducted by European researchers from the University of Glasgow, the University of Oxford, KU Leuven and the University of Leicester has revealed the shifting trends and persistent challenges in heart health and cardiovascular disease (CVD) in the UK. Published in the BMJ, researchers analysed the electronic health records of 22 million people from the Clinical Practice Research Datalink, CPRD GOLD and Aurum. CVD affects around seven million people in the UK and is a significant cause of disability and death. Affecting around 2.3 million people in the UK, coronary heart disease is the most common form of heart and circulatory disease and occurs when coronary arteries become narrowed by a build-up of fatty material within their walls. In the last 20 years, the study found a 19% reduction in the overall incidence of heart-related disease, including significant reductions in heart attacks and stroke, between 2000 and 2019, with ...
The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn. The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. This also included fraudulent activity that involved corporate executives distributing tainted and misbranded HIV medication, which amounted to $90m in losses. Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants. Adderall is a drug used to treat attention deficit hyperactivity disorder (ADHD). Also included in this crackdown were ...
The Pharmaceutical Research and Manufacturers of America (PhRMA) China Office announced that Mr. Leo Lee, President and Managing Director of Novartis China, has joined the PhRMA China Executive Liaison Group. Mr. Lee, a long-time veteran of the biopharmaceutical industry who has held senior management positions in a number of multinational corporations and has extensive experience in strategy development and implementation, business development and operational management, joins PhRMA’s China Executive Liaison Group and expresses its confidence that Mr. Lee will bring invaluable experience to the group, as well as its appreciation to the member companies for their continued support of PhRMA. Novartis is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA). About the PhRMA China Executive Liaison Group The China Executive Liaison Group (CELG) consists of the China General Managers of PhRMA member companies. As an important bridge between PhRMA China Office and member companies in China, the ...
Dive Brief Dexcom will lay off 535 employees in California, adding to the medical device industry’s long list of job cuts this year. The expected first date of separation is July 26, and the layoffs are connected to one site in San Diego, according to a Worker Adjustment and Retraining Notification filing with California. “Dexcom has decided to centralize its [U.S.] manufacturing operations in Mesa, Arizona, and refocus our San Diego operations as a Global Center of Excellence for Product Innovation,” company spokesperson James McIntosh wrote in an emailed statement. He added that Dexcom is offering support for employees, such as allowing them to apply for similar roles at another U.S. site with relocation assistance. Dive Insight The layoffs continue the consistent stream of job cuts in the medtech industry over the past 18 months. This year alone has seen numerous layoffs from top medical technology companies, including Medtronic, Zimmer ...
A new study found that eating a snack of baby carrots just three times a week significantly increased skin carotenoids in young adults. Levels of these phytonutrients were boosted even more when this healthy snack was combined with a multivitamin containing the carotenoid beta carotene. Carotenoids, which are responsible for the bright red, orange and yellow colors of many fruits and vegetables, can be measured in the skin to gauge fruit and vegetable consumption since diet is the only source of these pigments. Higher levels of skin carotenoids are associated with increased antioxidant protection and a lower risk of chronic diseases such as heart disease and certain cancers. This marker also reflects improved skin health and immune function. Mary Harper Simmons, Master of Science in Nutrition student at Samford University, said, “Previous studies have demonstrated that skin carotenoid levels can be increased by consuming three times the recommended serving of ...
Don Tracy, Associate Editor Ohtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years. The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Classified as a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), the treatment combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. According to the company, this marks the first time in 20 years that an inhaled product with a novel mechanism of action has been approved for COPD maintenance.1 “The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, PharmD, president, CEO, Verona Pharma, in a press release. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre ...
Don Tracy, Associate EditorThe inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward. Haemophilus influenzae bacteria, 3D illustration. Image Credit: Adobe Stock Images/Dr_Microbe Image Credit: Adobe Stock Images/Dr_Microbe The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to add Vaxelis to its preferential recommendations for the treatment of American Indian and Alaska Native infants with invasive Hemophilus influenzae type B (Hib). Developed as a collaboration between Merck and Sanofi, Vaxelis is the only hexavalent combination vaccine available in the United States. Vaxelis could potentially offer the advantage of reducing the number of injections needed in the first year of life compared to other vaccine schedules. Moving forward, the recommendation has the potential to significantly influence vaccine administration strategies and public health policies, especially in high-risk populations.1 “We ...
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