Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

A Device with no DHF is a Bad Thing in the Eyes of FDA

By Dr. Christopher Joseph Devine

…be captured in the DHF. The good news is device establishments can use today’s technology to create an electronic DHF. With software such as Master Control (note: Dr. D is…

…be captured in the DHF. The good news is device establishments can use today’s technology to create an electronic DHF. With software such as Master Control (note: Dr. D is…

Continue reading

Boston Scientific

Boston Scientific’s Strategy in Acquiring Symetis: Beef Up TAVI

By MedTech Intelligence Staff

…for varying patient pathologies and anatomy,” said Ian Meredith, M.D., executive vice president and global chief medical officer at Boston Scientific in a company news release. Symetis has two CE-marked…

…for varying patient pathologies and anatomy,” said Ian Meredith, M.D., executive vice president and global chief medical officer at Boston Scientific in a company news release. Symetis has two CE-marked…

Continue reading

Stress

Feeling Stressed? There’s a Device for That

By MedTech Intelligence Staff

…fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by taking our poll, which will appear on…

…fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by taking our poll, which will appear on…

Continue reading

Cybersecurity

Medtech Cybervangelists Hack Several Critical Care Devices

By MedTech Intelligence Staff

…to come. Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by taking our poll,…

…to come. Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by taking our poll,…

Continue reading

Alert

Experimental Balloon Procedure Puts Patients at Risk

By MedTech Intelligence Staff

…devices for this approach. Healthcare professionals and patients are encourage to report adverse events via the MedWatch Safety Information and Adverse Event Reporting Program. Find the fake news: This article…

…devices for this approach. Healthcare professionals and patients are encourage to report adverse events via the MedWatch Safety Information and Adverse Event Reporting Program. Find the fake news: This article…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Recipient of Illegal Buttock Injection Dies

By Dr. Christopher Joseph Devine

…wishes for continued professional success. Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by…

…wishes for continued professional success. Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by…

Continue reading

Cybersecurity, mhealth

Protecting Products in the Face of Cybersecurity Vulnerabilities

By Maria Fontanazza

…now. We find that questions still exist around how to approach cybersecurity. The world of cybersecurity standards and frameworks is very broad. The good news is that there’s a lot…

…now. We find that questions still exist around how to approach cybersecurity. The world of cybersecurity standards and frameworks is very broad. The good news is that there’s a lot…

Continue reading

Federal Trade Commission

FTC Approves Final Order on Abbott’s Acquisition of St. Jude Medical

By MedTech Intelligence Staff

…if it plans to acquire the lesion-assessing ablation catheter assets from Advanced Cardiac Therapeutics (the two companies formed a partnership to develop these devices in the United States). https://medtechintelligence.com/news_article/medtech-powerhouse-abbott-to-acquire-st-jude-for-25-billion/  …

…if it plans to acquire the lesion-assessing ablation catheter assets from Advanced Cardiac Therapeutics (the two companies formed a partnership to develop these devices in the United States). https://medtechintelligence.com/news_article/medtech-powerhouse-abbott-to-acquire-st-jude-for-25-billion/  …

Continue reading

Cybersecurity, mhealth

Cybersecurity Risks in Medical Devices Are Real

By Eric M. Luyer

…have hacked Dick Cheney’s heart”. The Washington Post. Retrieved from https://www.washingtonpost.com/news/the-switch/wp/2013/10/21/yes-terrorists-could-have-hacked-dick-cheneys-heart/?utm_term=.b66132885b11 “Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication”. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm…

…have hacked Dick Cheney’s heart”. The Washington Post. Retrieved from https://www.washingtonpost.com/news/the-switch/wp/2013/10/21/yes-terrorists-could-have-hacked-dick-cheneys-heart/?utm_term=.b66132885b11 “Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication”. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Refuse Facility Access to FDA and Bad Things Happen

By Dr. Christopher Joseph Devine

…of Santa’s workshops; Mr. Claus (upon request) must entertain an inspection from FDA. The good news is that since foreign establishment inspections take some planning on the part of FDA,…

…of Santa’s workshops; Mr. Claus (upon request) must entertain an inspection from FDA. The good news is that since foreign establishment inspections take some planning on the part of FDA,…

Continue reading