Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Medical device companies, especially those with real-time embedded-system products, are often burdened with lengthy verification cycles. Even small development efforts can result in months of ...

Physiologic monitoring devices are so ubiquitous in hospitals that it’s difficult to recall a time without them. The success of integrating this technology into patient care as a regular part of the ...

The integration of third-party components and software is an increasingly critical area of security risk that needs more attention from medical device manufacturers, says Anura Fernando, global head ...

The Food and Drug Administration is looking for computational software and services modeling the whole human heart to incorporate in a project that aims to evaluate new medical devices and therapies, ...

ORLANDO, Fla.--(BUSINESS WIRE)--HIMSS19 Booth #1533 – Ascom, the leading global healthcare Information and Communication Technology (ICT) provider, announced at HIMSS19 that its Digistat ® software ...

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 ...

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Read “FES design, simulation, and operation details” (below) for more information on the FES and model-based design. Engineers can save themselves a lot of effort by carefully evaluating their designs ...

Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...

The use of smartphones in healthcare is old news. Despite the decade-old trend, many challenges still exist with utilizing a patient’s smartphone, especially with optimizing both safety and patient ...