The latest rumors following FDA Commissioner Robert Califf, M.D.’s interview with The Washington Post, is that he may leave FDA under President-elect Donald Trump’s administration. Califf said that Trump’s transition…
The latest rumors following FDA Commissioner Robert Califf, M.D.’s interview with The Washington Post, is that he may leave FDA under President-elect Donald Trump’s administration. Califf said that Trump’s transition…
…consolidation continues Slow pricing growth due to GPOs, value analysis committees and other buying committees R&D remains strong, with device manufacturers spending about 7% of revenue to fund research Cybersecurity…
…consolidation continues Slow pricing growth due to GPOs, value analysis committees and other buying committees R&D remains strong, with device manufacturers spending about 7% of revenue to fund research Cybersecurity…
…the confusion that often ensues among healthcare providers and patients, CDRH has changed how it communicates device recalls. As of January 3, the center is posting recall information right when…
…the confusion that often ensues among healthcare providers and patients, CDRH has changed how it communicates device recalls. As of January 3, the center is posting recall information right when…
…today is highly sophisticated, feature-rich and has a combination of advanced electronics and software, making it increasingly complex. Thus, any operational or functional failure of such medical equipment can be…
…today is highly sophisticated, feature-rich and has a combination of advanced electronics and software, making it increasingly complex. Thus, any operational or functional failure of such medical equipment can be…
…topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation. FDA’s B-list of final guidance documents include: UDI: Direct Marking of Devices Evaluation and Reporting of…
…topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation. FDA’s B-list of final guidance documents include: UDI: Direct Marking of Devices Evaluation and Reporting of…
…hosting a webinar on January 12 to discuss the guidance and answer questions from attendees. Read the article by Battelle’s Stephanie Domas: Commodity Malware: What Medical Device Manufacturers Should Know…
…hosting a webinar on January 12 to discuss the guidance and answer questions from attendees. Read the article by Battelle’s Stephanie Domas: Commodity Malware: What Medical Device Manufacturers Should Know…
…Vietnam. In early 2015, Terumo BCT began manufacturing operations at its new facility in Ho Chi Minh City, Vietnam. The company produces blood components, therapeutic apheresis and cellular technologies. The…
…Vietnam. In early 2015, Terumo BCT began manufacturing operations at its new facility in Ho Chi Minh City, Vietnam. The company produces blood components, therapeutic apheresis and cellular technologies. The…
Will the ACA be repealed under the new administration? How will industry navigate the challenging reimbursement environment? What emerging technologies will impact business models in healthcare? PwC Health Research Institute…
Will the ACA be repealed under the new administration? How will industry navigate the challenging reimbursement environment? What emerging technologies will impact business models in healthcare? PwC Health Research Institute…
…leave the readers with just one takeaway. One: There is no such thing as minimum compliance. There is no such thing as maximum compliance. There is just compliance. In closing,…
…leave the readers with just one takeaway. One: There is no such thing as minimum compliance. There is no such thing as maximum compliance. There is just compliance. In closing,…
Device companies may also need to assess their product portfolios to provide a more comprehensive suite of tools, according to a new report….
Device companies may also need to assess their product portfolios to provide a more comprehensive suite of tools, according to a new report….
