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Stay Compliant: Understanding FDA's Cybersecurity Guidelines for MedTech Firms
Stay Compliant: Understanding FDA's Cybersecurity Guidelines for MedTech Firms
Medical devices have evolved and come a long way, transitioning from standalone to cloud-connected systems. These devices, from radiology equipment to wearables and implantable devices, have better interconnectivity and software components, which can help deliver better patient care. 
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Unlocking the Potential of SaMD: Your Comprehensive Guide to Software as a Medical Device in 2023
Unlocking the Potential of SaMD: Your Comprehensive Guide to Software as a Medical Device in 2023
Defined by the International Medical Device Regulators Forum, SaMD is software intended for medical purposes that functions independently of any hardware medical device. In simpler terms, SaMD can operate as a standalone healthcare solution, offering a range of medical functionalities without requiring integration with physical devices.
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How to Improve Cybersecurity on Your Connected Medical Devices
How to Improve Cybersecurity on Your Connected Medical Devices
The healthcare sector faces a significant threat from cybercriminals, with a concerning rise in attacks. A staggering 60% increase in cyberattacks against healthcare organizations was reported, reaching 1,426 attacks per week in 2022. Maintaining strong cybersecurity is critical for your connected medical devices.
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Top MedTech Events for Startups to Look Out for in 2024
Top MedTech Events for Startups to Look Out for in 2024
Participating in MedTech Events provides MedTech startups with a valuable opportunity to elevate their presence and visibility within the industry. Understanding the importance, we've curated a list of key MedTech events one can attend for 2024.
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Leaping from Just-Connected to Cloud-Native Medical Devices
Leaping from Just-Connected to Cloud-Native Medical Devices
Legacy medical devices “can’t jump” to homes. The issue here is similar to Tesla vs. the car industry. It took the car industry a decade to realize that pushing an electric engine into a legacy car can not begin to scratch the surface of the potential benefits realized by Tesla when they re-architected the electric car from scratch. An emerging architecture, "Cloud-Native medical device", is the key to the future of home care.
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Top 14 Global Medical Device Conferences to Attend in 2024
Top 14 Global Medical Device Conferences to Attend in 2024
Attending the right conference can significantly impact those in the medical device industry. It opens avenues for establishing business partnerships, expanding networks, and gaining valuable insights into medical devices, quality, regulatory matters, and industry trends - essential for career growth and staying up-to-date with new technologies.
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How No-Code is Transforming the Healthcare Industry
How No-Code is Transforming the Healthcare Industry
In the last decade, the healthcare sector has undergone a sea change, with technological advancements playing a crucial role. One emerging trend that is beginning to make its mark on the healthcare sector is the advent of no-code platforms. Users can easily create software for medical device companies or apps using No-Code tools without prior coding knowledge and experience. 
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Top 5 Trends That Are Shaping the Future of Advanced Medical Devices
Top 5 Trends That Are Shaping the Future of Advanced Medical Devices
The medical device industry is not only experiencing substantial growth but is also undergoing a transformation driven by technological innovation. Beyond addressing regulatory compliance, these technologies reshape patient care and medical practices. Reports indicate that 80% of healthcare providers plan to increase their investment in technology and digital solutions over the next five years, signifying a pivotal shift towards more technologically integrated healthcare.
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Setting a Standard for Cloud Computing in Medical Devices
Setting a Standard for Cloud Computing in Medical Devices
The development boom in software-embedded medical devices, together with off-the-shelf software, presents the MedTech industry a supportive environment for creating complex software systems. While this is undoubtedly an important boost for the healthcare industry, regulatory bodies, like the FDA, scramble to keep up with emerging medical architecture. Learn how the Association for the Advancement of Medical Instrumentation (AAMI) created a task group, providing a visible path for achieving and maintaining validation.
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What You Need to Do to Comply with New FDA Cybersecurity Law
What You Need to Do to Comply with New FDA Cybersecurity Law
The new FDA cybersecurity law prohibits a company from selling a connected medical device until the company proves it has a plan to monitor, update and fix the device in the field, should any security vulnerabilities arise. Moreover, the FDA now has the authority to force companies to comply, even for already commercialized devices. If you want to know how that translates to practical actions needed to be taken by medical device companies, read here.
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Top 4 Challenges of Medical IoT Platforms
Top 4 Challenges of Medical IoT Platforms
The speed of which the connectivity technology is being adopted makes it all the more important for clinicians to find an IoMT platform thatworks for them. These are the four challenges that you are most likely to face when attempting to implement an IoMT platform at your own healthcare facility.
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How to Improve Patient Engagement Solutions Using Remote Monitoring
How to Improve Patient Engagement Solutions Using Remote Monitoring
With technologies such as medical IoT devices becoming commonplace in medical settings, home-based care is emerging as an important part of the global health ecosystem. At the same time, patient engagement is increasingly recognized as a key part of quality healthcare practices.
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EU MDR Compliance: the Effect of the Updated EU MDR 2021 Regulations on Connected Medical Devices
EU MDR Compliance: the Effect of the Updated EU MDR 2021 Regulations on Connected Medical Devices
Connected IoMT devices are the answer to many of the challenges posed by the new EU MDR regulations. But in order to use them to their fullest potential, organizations will need specialized medical device platforms to manage the data these technologies are constantly generating.
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IoT in Healthcare: Benefits, Challenges, and Use Cases
IoT in Healthcare: Benefits, Challenges, and Use Cases
The U.S. healthcare IoT market is expected to reach $155.8 billion by 2027, signaling a rapid increase in the adoption of this technology. What are the benefits of using IoT in healthcare? What are the challenges? Here are answers and some use cases that illustrate what connected health solutions can really do
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Reimbursement for Remote Patient Monitoring 2021 Guide
Reimbursement for Remote Patient Monitoring 2021 Guide
This guide will outline what you need to know about reimbursement for remote patient monitoring in 2021, including the implications of these new changes.
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Benefits of an Effective Remote Patient Monitoring Platform
Benefits of an Effective Remote Patient Monitoring Platform
Your choice of remote patient monitoring platform impacts its success. How can you bring this promising technology into your own medical facility?
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Cloud Native Medical Devices: Revolutionizing Healthcare
Cloud Native Medical Devices: Revolutionizing Healthcare
In recent years, the healthcare industry has witnessed a significant transformation with the emergence of cloud native medical devices. These innovative devices leverage cloud computing technologies to enhance the delivery of healthcare services, improve patient outcomes, and streamline medical processes. This article explores the concept of cloud native medical devices, their benefits, challenges, and the future they hold in revolutionizing healthcare.
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Pioneering the Future of Healthcare with BioT's Regulated Cloud Platform: A Personal Perspective from the CEO
Pioneering the Future of Healthcare with BioT's Regulated Cloud Platform: A Personal Perspective from the CEO
In this blog post, our CEO shares a personal perspective on the BioT-regulated cloud platform and its impact on the future of healthcare. The platform revolutionizes patient outcomes through real-time data monitoring, remote adjustments, and personalized care based on data analysis. It addresses rising costs, enhances accessibility, and envisions a future where cloud-powered medical devices drive improved standards of care.
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Boosting Medical Device Innovation with No-Code Platforms: BioT's Path to Efficiency and Accessibility
Boosting Medical Device Innovation with No-Code Platforms: BioT's Path to Efficiency and Accessibility
In this blog post, we explore the transformative power of no-code platforms in boosting medical device innovation, with a particular focus on BioT's revolutionary approach. We discuss the challenges faced by medical device companies in developing backend cloud solutions and the role of no-code platforms in overcoming these obstacles.
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Envisioning Cybersecurity Labels for the Future of Medical Devices
Envisioning Cybersecurity Labels for the Future of Medical Devices
In the dawn of digital healthcare, with wearable and implantable devices becoming a reality, cybersecurity in patient care has never been more critical. The potential application of a cybersecurity labeling system for medical devices, akin to the Biden-Harris administration's initiative for smart devices, could revolutionize healthcare delivery. However, realizing this vision involves overcoming substantial challenges, including developing universally accepted standards and navigating a complex regulatory landscape.
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Navigating ISO 13485 Compliance in the Cloud: A Guide for Medical Devices
Navigating ISO 13485 Compliance in the Cloud: A Guide for Medical Devices
This blog discusses the challenges of ISO 13485 compliance in the cloud for medical device companies. It emphasizes the need for control over quality management systems, covering data integrity, cybersecurity, system performance, and continuous compliance. The conclusion highlights the importance of addressing these challenges to ensure regulatory compliance and foster innovation in the medical device industry.
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"Cloudified" Medical Devices: A Glance to the Future of Medicine
"Cloudified" Medical Devices: A Glance to the Future of Medicine
Making the leap from stand-alone medical devices to connected devices is required, as the Healthcare world is already in the midst of this shift. Learn what are the many aspects and challenges to consider when embarking upon this change.
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BioT Builds Cloud-Native Medical Devices on AWS
BioT Builds Cloud-Native Medical Devices on AWS
Partnering with Amazon Web Services has been an essential part of BioT’s product maturity. Working together, we became quite close and were recently asked to write a blog about our collaboration. We enjoyed sharing both our technological use of AWS as well as details about our commercial relationship, which got a serious upgrade recently after being accepted into the AWS ISV Accelerate Program, connecting independent software vendors to the AWS Sales organization. Read the full version here >>
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Key Takeaways from Spring 2022 Conferences - UX is Key, Connected Care is just the Beginning
Key Takeaways from Spring 2022 Conferences - UX is Key, Connected Care is just the Beginning
Spring 2022 was a busy season for medical device-related conferences. We were delighted to meet with partners around the world and hear first hand what’s driving their device development. Meeting with device manufacturers at conferences also gives us a unique opportunity to ‘take the pulse’ of the device industry, and identify key trends in the industry. In this blog, we share our latest insights.
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BioT’s year in review and predictions for 2023
BioT’s year in review and predictions for 2023
2022 has been an exciting year for the medical device market. 2023 promises to be just as exciting. In this blog, our CEO Daniel Adler shares insights from our work in 2022 and predictions for the upcoming year.
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Best 10 Medical Device Podcasts of 2022
Best 10 Medical Device Podcasts of 2022
The following list of medical device resources doesn’t come close to covering all that is out there, but each offers up good information, sometimes in a slightly different way. Here are our top picks.
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Why medical device manufacturers should care about reimbursement strategy
Why medical device manufacturers should care about reimbursement strategy
The medical device industry is moving towards a connected care model with IoMT. This is creating an increased role for device manufacturers in the reimbursement process. With the ability to accurately measure how and when a device is used manufacturers have access to key information needed for RPM and RTM CPT billing. In this blog, we explore how reimbursement strategy affects product adoption and why.
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Innovation in Pace with Regulation Part II - Meeting new regulatory requirements with cloud solution
Innovation in Pace with Regulation Part II - Meeting new regulatory requirements with cloud solution
Failure to regulatory changes can result in fines and penalties for manufacturers, as well as loss of market access. With the introduction of the new Medical Device Regulation (MDR), and the pending In Vitro Diagnostics Regulation (IVDR), the regulatory landscape in the EU has undergone tremendous change. Learn the challenges facing manufacturers and how to reduce the burden of compliance.
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Meeting the Challenge of Patient Adherence With Medical Devices
Meeting the Challenge of Patient Adherence With Medical Devices
Patient adherence to prescribed treatment plans is a significant healthcare challenge. Even when a patient’s life may depend upon their correctly following a treatment plan, there are still many who fail to do so. This is true for both pharmaceuticals and medical device-based treatments. The causes of non-adherence are multifaceted but thankfully so are the solutions. We explore the role that the internet of medical things (IoMT) and connected care solutions play in improving patient adherence.
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Familiar but Mysterious: Understanding Software as a Medical Device
Familiar but Mysterious: Understanding Software as a Medical Device
Software as a medical device (or SaMD) is one of the fastest growing sectors in healthcare. We explore what it means for software to be considered a medical device in and of itself. Learn the advantages to SaMD, the regulatory requirements, and challenges facing manufacturers.
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Top 15 News Sites and Blogs That Medical Device Companies Should Be Aware of in 2022
Top 15 News Sites and Blogs That Medical Device Companies Should Be Aware of in 2022
It will come as no surprise to any medical device company that medical technology is forever changing. Advancements and new innovations have become a constant. Because of that, it’s imperative for companies to stay on top of any and all medical technology, or MedTech, news, best practices, and regulations. We’ve compiled our list of the top 15 news sites and blogs that any medical device company should keep their eye on.
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Innovation in Pace with Regulation Part-I: How Medical Device Companies Can Use Cloud-Solutions to Minimize the Regulatory Burden
Innovation in Pace with Regulation Part-I: How Medical Device Companies Can Use Cloud-Solutions to Minimize the Regulatory Burden
Regulation does not need to slow down the pace of innovation. We explore how companies can navigate the transition fulfilling regulatory requirements without impeding innovation. Learn how cloud-based software can quickly respond to fast-changing market conditions and new regulatory requirements eliminating the need for medical device companies to constantly invest in education, development and regulation.
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5 Tips for Cybersecurity Management for Cloud Connected Medical Devices
5 Tips for Cybersecurity Management for Cloud Connected Medical Devices
If you currently use connected medical devices or plan to, here are five tips that will help you manage your medical device cybersecurity obligations.
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5G in Healthcare: Will Medical IoT Devices Be the Next Big Thing?
5G in Healthcare: Will Medical IoT Devices Be the Next Big Thing?
Medical IoT devices have the potential to vastly improve the quality of care of patients, but they will need the help of 5G technology. Healthcare providers will be able to achieve excellent results for many patients while also increasing access to health services, improving convenience, and building a store of knowledge for future study.
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4 Benefits of Connecting Medical Devices to the Cloud
4 Benefits of Connecting Medical Devices to the Cloud
Let’s review a few of the biggest benefits of medical device connectivity and how connected medical devices are reshaping patient care.
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IoT Use Cases in Healthcare: Innovative Applications of the Internet of Medical Things
IoT Use Cases in Healthcare: Innovative Applications of the Internet of Medical Things
Learn about some fascinating IoT use cases in healthcare and why they’re so effective at improving healthcare management goals
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