July 2019 SaMD PreCert Update
We have been following the FDA's Software as Medical Device (SaMD) Pre-Cert pilot. The premise of...
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Are We Over Connected Yet?
Some of us remember when distributed medical devices such as patient monitors had their own...
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Disrupting Nurse Call
Change is disrupting nurse call. After decades of slow incremental change, the pace of change is...
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FDA Seeks SaMD PreCert Mock Applicants
FDA has issued a request for SaMD developers to try out the PreCert excellence appraisal process....
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Capsule Tech Acquires Bernoulli Health: Analysis
On April 30, 2019, Capsule Tech announced that it is acquiring Bernoulli Health for an undisclosed...
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Healthcare Messaging & Orchestration — 2019
Messaging is all about getting things done. Whether you call it Secure Texting, Secure Messaging,...
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FDA on Modifying AI
Recently the FDA released a discussion paper on a Proposed Regulatory Framework for Modifications...
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Hill-Rom Acquires Voalte: Analysis
Hill-Rom announced March 12, 2019 that it was in the process of acquiring Voalte for $180 million....
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ONC Finds Possible Merit in FDA Pre-Cert
We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several...
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Medical Device & IoT Summit
New Dates, Same Venue! Join us in Boston on February 25-26 April 23-24 to dig deep into medical...
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Another Update to the FDA’s Pre-Certification Model
The FDA has released a January 2019 update to its working model of the precertification...
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FDA on Software That Isn’t a Medical Device
The 21st Century Cures Act of 2016 (Cures) had many provisions including defining what kinds of...
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FDA to Divide Cybersecurity Risk Into Two Tiers
Medical devices that contain software, or are software, are subject to the well-known medical...
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What You Really Need to Know about Digital Health
You Won't Find This Information in Publications or Vendor Blogs Just where does one draw the...
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Managing Digital Health Regulatory Uncertainty
Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and...
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