Blog
European Commission plans greater oversight of notified bodies
By Stewart Eisenhart, Emergo Group
International wireless approvals: An overview for medical device manufacturers
By Stewart Eisenhart, Emergo Group
Medical device manufacturers interested in selling their wireless products internationally face two sets of regulatory hurdles: medical and wireless. Medical devices using wireless components must be approved by both medical and wireless authorities in most markets.
Cool technology of the week – November 29
While in China last week, I participated in a ribbon cutting ceremony for a new private (rather than public) funded hospital. Each patient room included several high tech amenities including showers that transition from clear glass to frosted glass at the touch of the button.
Subcutaneous ICD: A lesson in FDA approval
Reflecting on our IT progress
Slow medicine
Medicine is changing.
We are moving from Mom-and-Pop medicine to Big Box corporate machine medicine.
We are moving from innovation to rote checklists.
We are moving from tangible slow paper to imperceptible high-speed electrons.
The patient experience of EHRs
I’m often asked if the use of EHRs diminish clinician-patient interactions in the exam room.
At BIDMC, Jan Walker and Tom Delbanco have done focus groups with patients about technology. Generally, they found that patients will embrace technology that gives them access to information about their care. At BIDMC, where we have both a patient portal and Wi-Fi throughout the hospital, doctors often arrive at the bedside to find a patient viewing lab results on an iPad, ready with questions about their tests.
Pakistan to establish regulatory system for medical devices
By Stewart Eisenhart, Emergo Group
The Pakistani government has signed into law legislation (PDF) to formally regulate medical devices and pharmaceutical products in the country.
Giving thanks for things that matter
By Vector Staff
At this Thanksgiving, we’d like to pause in appreciation of our researchers and innovators who work hard to find answers and build better lives for patients. We extend an equal thanks to the foundations, donors, investors, companies – and you, the public – who support their work.
Chinese regulators pursue heavier penalties for medical device violations
By Stewart Eisenhart, Emergo Group
The State Food and Drug Administration (SFDA) of China has set new rules (translated via Google) effective January 1, 2013 that would mete out more severe punishment to medical device and pharmaceutical manufacturers for certain violations.