Question
Full disclosure: I do some medical device marketing consulting for ImaCor and think their innovation is impressive. Primarily used in cardiac surgeries, a traditional transesophageal echocardiogram (TEE) consists of a probe and ultrasound system. The...
Hi Gang, I was at the Medical Devices Summit in Boston this week, and one of the attendees asked a good question:"Why don't we see a more widespread use of virtual doctors? We see some here and there, but with the technology already available, why do...
Elizabeth Doyle
Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
March 2018
I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone point me towards such a list? Or do you have a personal list compiled over the years that I could use as a reference point? Application-wise, ri...
A group member recently sent me a message I didn’t understand. "The Florida shooting victims remind me of thousands of US patients who die every year from ‘pacing-induced heart failure’ due to bypassing the cardiac conduction system." Intrigued, I vi...
I was not completely aware to Medicare & Medicaid Services (CMS) agency. It regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments and approve Laboratory Developed...
Looking for recommendations on Clinical Research Organisations to undertake phase 1/2 clinical trials for a newly developed medical device and a therapy.source: https://www.linkedin.com/groups/78665/78665-6380263623817719811
Tomorrow there is a medical device webinar from PRISYM ID on how to successfully integrate SAP with your label lifecycle management solution. This solution will accelerate your business processes through end-to-end automation. Integration benefits in...
"Of the 250 technologies I reviewed, we denied coverage for 67% of them. All were FDA cleared and many came from major medical device manufacturers," said Nic Anderson, formerly the Senior Medical Technology Analyst at Intermountain Health. Which one...
Dear all,does anyone has insights into the interpretation of Article 45 of the MDR (Article 41 in the IVDR). It sais that as part of the market surveillance activities, there is a change that the competent auhorities will review the technical documen...
I was talking with Carlos Soares, the newest member of our Medical Devices Group Advisory Board, about supply chain efficiencies for medical device companies. He observed, "I see a lot of issues that never get resolved until they reach a break point ...
