The impact of the AI Act on Medical Devices

With the publication of the agreed text of the European Union’s long-awaited Artificial Intelligence Act (AI Act) now available (subject to minor linguistic and numbering tweaks), the message to medtech companies is clear: they will need to begin their journey toward compliance by understanding ...

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Decoding FDA’s Draft Guidance On CSA

The current state of validation is seen as a hindrance to quicker deployments, with an emphasis on adhering to thorough documentation practices instead of building systems that align effectively with their intended use. A risk-based approach to validation has been around ...

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FDA gives full recognition to AAMI cybersecurity guidance document

FDA grants full recognition to AAMI's pioneering guidance document on medical device cybersecurity, ANSI/AAMI SW96:2023, Standard for medical device security - Security risk management for device manufacturers.

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FDA Issues Final Guidance on Cybersecurity in Medical Devices

he U.S. Food and Drug Administration (FDA) has recently unveiled its comprehensive final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

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FDA Premarket Notification 510(k)

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). There is no 510(k) form; however, 21 CFR 807 Subpart E

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Clinical Decision Support Software Regulations

We will mainly comment and ask critical questions on the practical implementation of the regulatory framework for medical device software (especially clinical decision support software), with a reference to the available international guidance documents and their limitations. As ...

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3 Key Benefits Of Deploying Edge AI At The Point Of Care

The point of care is shifting, with monitoring, diagnosis, and treatment taking place increasingly outside the conventional hospital setting and moving into patients’ homes. This is an exciting shift in the paradigm of healthcare. The arrival of cloud computing has allowed ...

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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift

The increasing degree of digitalization and interconnectedness, along with the rising number of cyber malicious activities at the global level, has effectively rendered cybersecurity an increasingly valued position on a business level.

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Mobile Health Apps – which U.S. federal laws may apply?

The Federal Trade Commission (FTC) has published on its web site an interactive tool that helps mobile health apps manufacturer to navigate laws and rules that may apply to their app. Privacy and security are important considerations for any app ...

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The Evolving FDA Regulatory Landscape of Artificial Intelligence

Whether it’s asking ChatGPT to rewrite your resume, getting behind the wheel of a self-driving vehicle, trusting the cybersecurity protocols of the cloud-storage platform to which you’re saving your family vacation photos, or ...

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The Road To ISO 13485 Certification: Tips For Effective Audits

We all know a moving target is hardest to hit. Whether it’s a high-speed tennis ball or an audit, keeping your eye on the target at all times is the key to success. Even the mention of the term “audit” can send people cowering ...

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The Buzz About Medical Device Cybersecurity in 2022 and Beyond

Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance ...

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Top ten observations from 2022 in life sciences digital and analytics

Life sciences companies are making progress in adopting and deploying digital and analytics. But they can go further and faster by heeding some lessons from the past few years. Looking toward the new year is a good time ...

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The health benefits and business potential of digital therapeutics

Around the world, the burden of chronic disease is increasing at a rapid pace. Unfortunately, most of these conditions are irreversible and need to be managed through lifelong medication use. However, many patients ...

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The FDA & EU IVDR Regulatory Frameworks For IVD SaMD

Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746. Therefore, ...

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GPT Applications in Healthcare?

Natural language computer applications are becoming increasingly sophisticated and, with the recent release of Generative Pre-trained Transformer 3, they could be deployed in healthcare-related contexts that have historically comprised ...

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IVD Software as a Medical Device (SaMD)

In recent years, software has been playing an increasingly critical role in the medical device world. Software with a medical intended use can be embedded as part of a medical device (and regulated as part of the device) or it can also be considered a medical device by itself ...

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Time extension for MDR transition

The EU Commission will present elements of a legislative proposal for a targeted amendment of the MDR and IVDR during the EPSCO Health Council on 9 December 2022. Those elements are based on the input received so far from national experts and stakeholders ...

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The promise of digital therapeutics

Investments in digital-therapeutics companies in the United States have grown by an average of 40 percent a year over the past seven years to reach more than $1 billion in 2018. Investors’ enthusiasm mirrors the growing demand for digital-therapeutic products ...

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What’s Wrong With Your Medtech R&D Department?

Larry Blankenship, director of Boulder iQ wrote in the current issue of www.meddeviceonline.com: “Voicing complaints about R&D departments in medical device companies is nothing new. Executives, staff members, and investors commonly ask, “What’s wrong with ...

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Five ways that life science companies can build tech talent

Life science organizations should have little difficulty attracting and retaining tech talent. The salaries that they offer are typically higher than those in other industries. The work—improving health and the quality of life ...

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FDA vs. Congress: The Software Showdown

September 2022 will be remembered as a seminal turning point in digital health in the U.S. It was not FDA’s concluding its Software Precertification Pilot program, where the FDA finally admitted and further validated our cGMPs for SaMD approach1 that a new legislative authority ...

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Are you Submission Ready?

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes into being “submission-ready.” It is important not to underestimate the large amount ...

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FDA’s New Draft Guidance on Cybersecurity

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device lifecycle. There are several major changes ...

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Tips For Your Virtual Meetings With The FDA

In the past two years, the pandemic has kept sponsors developing drugs, biological products, and medical devices from meeting in person with FDA. Advisory committee meetings, workshops, and conferences have gone virtual, too. While some sponsors have hopes ...

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Medtech Cyber-Incidents – A Costlier Problem Than You Think

To help medtech companies understand their business-threatening cyber risks, we offer an infographic and related taxonomy classifying cyber risks into five categories of harmful events — operational interference, ...

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The 5 Common Medical Device Startup Challenges (& How To Overcome Them)

The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and risk for enthusiastic, ...

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FDA Releases Guidance On Cybersecurity In Medical Devices

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare environment, both in the hospital ...

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Key Design Considerations For Digitally Connected Injectors

Digital health has become an integral part of clinical trials and the commercial patient support ecosystem. In the past two years, there has been a significant transformation in the way clinical trials are conducted, as well as how healthcare providers support patients ...

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Medical Device Interoperability

Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, ...

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