Today the Securities and Exchange Commission has charged Theranos CEO and founder Elizabeth Holmes, along with the company’s former President Sunny Balwani with fraud: Raising more than $700 millions from…
Today the Securities and Exchange Commission has charged Theranos CEO and founder Elizabeth Holmes, along with the company’s former President Sunny Balwani with fraud: Raising more than $700 millions from…
…30. “If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties,” FDA stated. https://medtechintelligence.com/news_article/pentax-medical-recalls-certain-duodenoscopes/ …
…30. “If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties,” FDA stated. https://medtechintelligence.com/news_article/pentax-medical-recalls-certain-duodenoscopes/ …
Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides…
Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides…
Rice University has received an award from the National Science Foundation that will help researchers develop a platform technology for non-invasive diagnostic testing. The team, comprised of co-investigators from Rice…
Rice University has received an award from the National Science Foundation that will help researchers develop a platform technology for non-invasive diagnostic testing. The team, comprised of co-investigators from Rice…
In the past month, FDA has removed 2,546 medical device establishments from the agency’s registration database. According to a post on Registrar Corp.’s website, there were 27,124 registered establishments on…
In the past month, FDA has removed 2,546 medical device establishments from the agency’s registration database. According to a post on Registrar Corp.’s website, there were 27,124 registered establishments on…
Attacks against software vulnerabilities seem to be occurring on a regular basis. Although the concern is top of mind with IT experts across all industries, tackling cybersecurity issues can be…
Attacks against software vulnerabilities seem to be occurring on a regular basis. Although the concern is top of mind with IT experts across all industries, tackling cybersecurity issues can be…
…move the dial. The good news is that stakeholder engagement and communication, while absolutely essential to any change initiative, does not necessarily require heavy investment in fancy new technologies or…
…move the dial. The good news is that stakeholder engagement and communication, while absolutely essential to any change initiative, does not necessarily require heavy investment in fancy new technologies or…
Yesterday FDA announced that it would be permitting the marketing of the Banyan Brain Trauma Indicator, the first blood test to evaluate mild traumatic brain injury (mTBI) in adults. The…
Yesterday FDA announced that it would be permitting the marketing of the Banyan Brain Trauma Indicator, the first blood test to evaluate mild traumatic brain injury (mTBI) in adults. The…
Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for…
Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for…
…facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website. https://medtechintelligence.com/news_article/why-duodenoscopes-are-so-tough-to-clean/ …
…facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website. https://medtechintelligence.com/news_article/why-duodenoscopes-are-so-tough-to-clean/ …
