FDA Takes Step Backwards with New MDDS Guidance
This summer, FDA proposed lifting regulations from certain currently regulated medical devices....
Read MorePosted by Tim Gee | Connectivity, Healthcare IT, Patient Safety, Standards & Regulatory |
This summer, FDA proposed lifting regulations from certain currently regulated medical devices....
Read MorePosted by Tim Gee | Connectivity, Healthcare IT, Strategy & Planning |
As noted before, from time to time I answer questions and exchange ideas with folks from...
Read MorePosted by Tim Gee | Standards & Regulatory |
I've been getting a lot of questions about this. Here's the latest: I am hoping you can answer this question for me. Â Would [redacted company name] a data storage company come under the MDDS final Ruling? Â Are hw/sw services all...
Read MorePosted by Tim Gee | Standards & Regulatory |
The real news behind the final rule is FDA’s stated intent to exercise “enforcement discretion.”
Read MorePosted by Tim Gee | Standards & Regulatory |
One should not mistake past regulatory discretion for lackadaisical enformcement on the part of the FDA.
Read MorePosted by Peter | Standards & Regulatory |
It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
Read MorePosted by Tim Gee | Standards & Regulatory |
Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.
Read MorePosted by Tim Gee | Clinical Alarms, Clinical Decision Support, Company Profiles, Connectivity, Remote Monitoring, Strategy & Planning, Surveillance Monitoring |
On April 30, 2019, Capsule Tech announced that it is acquiring Bernoulli Health for an undisclosed...
Read MorePosted by Tim Gee | Company Profiles, Messaging & Orchestration, Strategy & Planning |
Hill-Rom announced March 12, 2019 that it was in the process of acquiring Voalte for $180 million....
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