According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to climb to USD 715.00 million by 2033, expanding at a ...
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The ...
Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical ...
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company"), manufacturer of eyonis®, a suite of ...
Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...
Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (Nov 10th - Nov 11th, 2025)" training has ...
Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...
Beyond Tariffs: The Software Supply Chain Risks Every Medical Device Manufacturer Should Be Watching
By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...
(CNN) — Nefarious individuals hacking into your pacemaker? It's not just the plot of some sci-fi movie. It's a real-life threat, according to the Food and Drug Administration. The FDA is warning ...
Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and ...
Heart disease patients like Dick Cheney are vulnerable to buggy software and hack-attacks aimed straight at the devices implanted near their hearts. Worse, they have no legal recourse. But open source ...
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