FDA has awarded up to $6 million in grants to support the development of pediatric medical devices. The awards are in the form of five grants that will be distributed…
FDA has awarded up to $6 million in grants to support the development of pediatric medical devices. The awards are in the form of five grants that will be distributed…
…is a great example of Masimo’s ongoing commitment to automating patient care, whether it’s making pulse oximeters accurate when you need that accuracy most, creating new noninvasive monitoring technologies such…
…is a great example of Masimo’s ongoing commitment to automating patient care, whether it’s making pulse oximeters accurate when you need that accuracy most, creating new noninvasive monitoring technologies such…
…a serious note, people really do need to exercise some level of common sense when it comes to medicine. Elective medical procedures such as “buttocks injections” should occur in a…
…a serious note, people really do need to exercise some level of common sense when it comes to medicine. Elective medical procedures such as “buttocks injections” should occur in a…
…baht ($22.2 billion) annually, of which about 100 billion baht ($3.17 billion) comes from foreign visitors. The government is encouraging private hospitals to step up their investment in research and…
…baht ($22.2 billion) annually, of which about 100 billion baht ($3.17 billion) comes from foreign visitors. The government is encouraging private hospitals to step up their investment in research and…
This week FDA issued a draft guidance to further clarify the considerations related to uncertainty in benefit-risk determinations that support premarket decisions for medical devices. The draft, “Consideration of Uncertainty…
This week FDA issued a draft guidance to further clarify the considerations related to uncertainty in benefit-risk determinations that support premarket decisions for medical devices. The draft, “Consideration of Uncertainty…
…letter to company stockholders. He went on to state that the company is in default and owes at least $60 million to its unsecured creditors. The company has already started…
…letter to company stockholders. He went on to state that the company is in default and owes at least $60 million to its unsecured creditors. The company has already started…
…Transition Period https://medtechintelligence.com/column/new-mdr-one-year-into-the-transition-period/ 4. Simplifying Medical Device Labeling in a Complex Environment https://medtechintelligence.com/feature_article/simplifying-medical-device-labeling-in-a-complex-environment/ 3. EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation https://medtechintelligence.com/column/eu-mdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ Learn more about this…
…Transition Period https://medtechintelligence.com/column/new-mdr-one-year-into-the-transition-period/ 4. Simplifying Medical Device Labeling in a Complex Environment https://medtechintelligence.com/feature_article/simplifying-medical-device-labeling-in-a-complex-environment/ 3. EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation https://medtechintelligence.com/column/eu-mdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ Learn more about this…
…on results of the two-year COMPASS study. The COMPASS-XT study collected safety data on the subjects who participated in the COMPASS study for three more years, generating five years of…
…on results of the two-year COMPASS study. The COMPASS-XT study collected safety data on the subjects who participated in the COMPASS study for three more years, generating five years of…
…(2017, March 16). How Virtual Reality Is Helping Heal Soldiers With PTSD. Retrieved from https://www.nbcnews.com/mach/innovation/how-virtual-reality-helping-heal-soldiers-ptsd-n733816 Fink, C. (2017, September 28). How VR Saves Lives In The OR. Retrieved from https://www.forbes.com/sites/charliefink/2017/09/28/how-vr-saves-lives-in-the-or/#502adf523099…
…(2017, March 16). How Virtual Reality Is Helping Heal Soldiers With PTSD. Retrieved from https://www.nbcnews.com/mach/innovation/how-virtual-reality-helping-heal-soldiers-ptsd-n733816 Fink, C. (2017, September 28). How VR Saves Lives In The OR. Retrieved from https://www.forbes.com/sites/charliefink/2017/09/28/how-vr-saves-lives-in-the-or/#502adf523099…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. ( July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Anigan, Inc. Accessed August 27, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. ( July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Anigan, Inc. Accessed August 27, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm…
