Dive Brief The U.S. Food and Drug Administration and the Veterans Health Administration have signed an agreement to increase medical product manufacturing capacity and flexibility in times of crisis. The agencies will create “digital stockpiles” to improve the resilience of domestic supply chains during emergencies, shortages and pandemics. The digital stockpiles will store electronic plans, instructions and methods to make and test medical products to enable trusted suppliers to quickly scale up production when needed, according to the agencies. Dive Insight The COVID-19 pandemic exposed the shortcomings of existing supply chains. When the crisis struck, the U.S. and other countries struggled to meet demand for personal protective equipment and other medical devices used in the response to the coronavirus. The experience led officials to consider how to make supply chains more resilient and able to cope with crises. Now, the FDA has signed a memorandum of understanding with the VHA. ...
A growing team of nearly 50 employees at the neurotech startup Paradromics is working on a brain implant that sounds like the work of science fiction. And it has caught the attention of federal regulators. Paradromics, founded in 2015, is developing a device that could help patients with severe paralysis regain their ability to communicate by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface. CEO Matt Angle said the designation, in addition to a $33 million funding round the company also announced Thursday, will help Paradromics bring its device to market. Paradromics is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Experts believe the ...
May 12, 2023 By Sean Whooley Leave a Comment Abbott (NYSE:ABT) announced a new series of programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care in under-represented populations. The additions to Abbott’s “Diversity in Clinical Trials” initiative build on partnerships, scholarships and the focus on diversified patients. Abbott applied these to its own clinical trials throughout the initiative’s first year. Within that first year, the company established a Diversity in Clinical Trials Medical Advisory Board. Through $5 million in grants, it also sponsored more than 300 scholarships at four historically black colleges and university (HBCU) medical schools, plus the National Black Nurses Association and National Association of Hispanic Nurses. Within this program expansion, Abbott launched a new initiative with the Norton Healthcare Foundation. It aims to build and implement new models of sustainable clinical research alongside the Institute for Health Equity in Louisville, Kentucky. ...
Real-time patient experiences is the missing element to most electronic health records, artificial intelligence, and machine learning models today. Anish Patankar, SVP, GM, Oncology Informatics Software, Elekta Cancer treatment has come a long way in recent years and is now evolving more rapidly through the integration of artificial intelligence (AI) tools, such as machine learning (ML). Currently, health data exists in many forms, including electronic health records (EHR), diagnostic images, genomic and molecular data, pharmacological data, and patient-reported data. The creation of state-of-the-art cancer treatments can be enhanced by the ways clinicians leverage data to optimize care, and there’s no better way to achieve this than through the use of AI. Completing the picture There is a missing element to most EHR, AI, and ML models today – real-time patient-reported outcomes. This type of data refers to information regarding patients’ experiences with their medical conditions, treatments, and healthcare providers, ...
By Nadine Yousif & Robin Levinson-King BBC News The US Supreme Court has extended until Friday a temporary block on limits to access of a popular abortion pill. A Texas judge suspended approval of abortion drug mifepristone on 7 April, questioning its safety. Parts of that decision were upheld on appeal, prompting the Biden administration to make an emergency request to the Supreme Court. It’s the most significant such case since the Supreme Court last year ended the nationwide right to abortion. The pill – used in more than half of abortions in the US – was first approved by the Food and Drug Administration (FDA) more than two decades ago. Here’s how we got here. What has happened so far? Earlier this month, a federal judge in Texas issued a preliminary injunction revoking the FDA’s approval for the drug while he hears a lawsuit brought by a group of ...
Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved. Katie Hobbins | Apr 19, 2023 Recently, a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall. Makers of Class III PMA devices are offered five different types of supplements to allow for product improvements. Only one of the supplements — namely, panel track supplements — actually require clinical evidence for implementation and, as such, are the least-used type of the five, (approximately 1%). In contrast, the most used supplement type is a 30-day notice. A 30-day notice is used when a company makes changes to a manufacturing procedure or the way it makes a device. In the study, investigators analyzed devices approved through ...
April 11, 2023 By Jim Hammerand Leave a Comment FacebookTwitterLinkedIn分享 Burn patients wear the masks on their face to heal scars and prevent complications. “I almost prefer to have the mask on,” said patient Laura Weibel (pictured on the left). [Photo courtesy of Formlabs] 3D-printed masks are removing a traumatic part of treatment for children recovering from severe burns. At Romans Ferrari pediatric rehabilitation center in France, a child with facial burns previously would need to sit motionless for a plaster cast of their face to make a mask for treatment. The masks compress the skin to help scars heal without complications, but the heat from warm plaster bandages can make young burn victims uncomfortable — or worse. “It required the patients to be motionless for the duration of the plaster cast that lasts about half an hour, which can be difficult, especially for children, and could reactivate symptoms of post-traumatic stress ...
The pharmaceutical foreign trade industry is fiercely competitive, demanding a constant grasp of the latest market information and tech tools to successfully expand business. Today, we're showcasing must-have websites and practical tools for pharmaceutical foreign trade professionals, empowering you to operate more efficiently.
Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
The UK trade association for in vitro diagnostics (IVD) companies BIVDA has welcomed the NHS Medtech Funding Mandate, a new policy aimed at accelerating the uptake of medical devices, diagnostics and digital products in the NHS. The new Mandate, which will come into effect from 1 April 2020, will aim to enable patients to access ‘pioneering’ IVD devices faster and with greater ease. For products to qualify under the Mandate, they must demonstrate that they are effective, deliver material savings to the NHS, are cost-saving in-year and are affordable to the NHS. The Mandate policy is set to be published annually in December, following a review and feedback improvement cycle. A list of technologies that meet the MedTech Funding Mandate criteria is expected to be published before the end of July. “The publication of the Mandate is an opportunity to celebrate the UK as a leader in technologies for health ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.