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Mashup Score: 0How Early Talks With The FDA Can Pave Your DTx Approval Pathway - 3 month(s) ago
Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.
Source: www.meddeviceonline.comCategories: General Medicine News, Future of MedicineTweet
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Mashup Score: 04 Key Trends And 2 Attention Areas For Medtech Success In 2024 - 11 month(s) ago
After a brief recap of medtech performance in the past year, these Ernst & Young experts share their perspective on the four key trends for medtechs to consider in 2024 (smart connectivity and more), as well as the two focus areas for medtech companies to take strategic action.
Source: www.meddeviceonline.comCategories: General Medicine News, General HCPsTweet
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Mashup Score: 0India Aims To Boost Medical Device Industry With New Initiative - 1 year(s) ago
India’s government has approved a new initiative aiming for a 20% annual growth rate for medical devices, which is dubbed as a “Sunrise Sector.” The initiative will streamline regulations, add a new push for manufacturing capacity, and strengthen opportunities for R&D collaboration. The aim is for both local and global companies to benefit.
Source: www.meddeviceonline.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 2
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
Source: www.meddeviceonline.comCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 0
Big-picture messaging such as “improved outcomes” or “healthier life” are not enough to justify continued interaction with wearable and nearable medical devices or platforms. Instead, designers need to understand how they are asking users to engage and participate in the monitoring or treatment process and create useful, seamless interactions.
Source: www.meddeviceonline.comCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 1
Conventional medical devices have revolutionized patient diagnostics and treatments. The future is heading rapidly toward a point where advanced software such as data science and AI techniques are driving a new wave of innovation and positive health impacts.
Source: www.meddeviceonline.comCategories: Healthcare Professionals, Latest HeadlinesTweet
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Mashup Score: 0
Despite the pace of innovation in healthcare today, underrepresented populations across America are not receiving optimal care. Through digital healthcare innovations like telehealth and digital therapeutics, the industry can — and should — begin to address these disparities and shortcomings.
Source: www.meddeviceonline.comCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 0Germany's Digital Medical Device Regulations: A Framework For The World To Follow, Part III - 2 year(s) ago
Germany’s BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the…
Source: www.meddeviceonline.comCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 0
At the end of 2019, the Digital Healthcare Act introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany. Many consider the act a breakthrough that allowed Germany to advance from a relatively low level of healthcare digitization (among developed countries) into a role model position. Two years and 28 approved digital health apps later,…
Source: www.meddeviceonline.comCategories: Future of Medicine, Latest HeadlinesTweet
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Mashup Score: 0
At the end of 2019, the Digital Healthcare Act introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany. Many consider the act a breakthrough that allowed Germany to advance from a relatively low level of healthcare digitization (among developed countries) into a role model position. Two years and 28 approved digital health apps later,…
Source: www.meddeviceonline.comCategories: Future of Medicine, Latest HeadlinesTweet
How Early Talks With The FDA Can Pave Your DTx Approval Pathway https://t.co/u9zpBx3fwv https://t.co/ptfnDHiOWe