CMS Slaps Theranos with Sanctions, Bans CEO from Running Labs

By MedTech Intelligence Staff

CMS has taken a hard line against Theranos, imposing several sanctions against the company, including banning CEO Elizabeth Holmes from operating a lab for two years. It was back in…

CMS has taken a hard line against Theranos, imposing several sanctions against the company, including banning CEO Elizabeth Holmes from operating a lab for two years. It was back in…

Continue reading

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

Tick-Tock: 15-Days and the Clock is Ticking

By Dr. Christopher Joseph Devine

…a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Eolane Vailhauques. Accessed July 4, 2016. Retrieved…

…a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Eolane Vailhauques. Accessed July 4, 2016. Retrieved…

Continue reading

Abbott

FDA Says Yes to Abbott Vascularā€™s Fully Absorbable Stent

By MedTech Intelligence Staff

…it is completely absorbed, four small platinum markers remain in the artery walls to help the physician identify where the scaffold was originally placed. “The Absorb bioresorbable scaffold represents a…

…it is completely absorbed, four small platinum markers remain in the artery walls to help the physician identify where the scaffold was originally placed. “The Absorb bioresorbable scaffold represents a…

Continue reading

gavel

Mesh Lawsuits Shine Light on Material Sourcing and Selection

By Maria Fontanazza

…from the perspective of educating companies and working with suppliers? Torgerson: Any company that is a supplier or manufacturer of a component or device that will be used in any…

…from the perspective of educating companies and working with suppliers? Torgerson: Any company that is a supplier or manufacturer of a component or device that will be used in any…

Continue reading

mHealth apps, FDA, FCC, regulations

MEDICAā€™s Mobile Medical App Competition

By Dr. Lutz Retzlaff

…conceived by a French team. In combination with a Bluetooth-enabled stick that is compatible with commercially available e-cigarettes, the app records the precise amount of vapor consumed, from to the…

…conceived by a French team. In combination with a Bluetooth-enabled stick that is compatible with commercially available e-cigarettes, the app records the precise amount of vapor consumed, from to the…

Continue reading

Top Three Disconnects in Product Development

By MedTech Intelligence Staff

…software 29% Communication with service or component vendors 12% Aligning engineering and clinical considerations 51% From early design to prototyping 7% From prototyping to manufacturing 32% Aligning business objectives with…

…software 29% Communication with service or component vendors 12% Aligning engineering and clinical considerations 51% From early design to prototyping 7% From prototyping to manufacturing 32% Aligning business objectives with…

Continue reading

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

Fail to Register as an Establishment: Bad Things Happen

By Dr. Christopher Joseph Devine

system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Berwickshire Electronic Manufacturing, Ltd. Accessed June 26, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506423.htm…

system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Berwickshire Electronic Manufacturing, Ltd. Accessed June 26, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506423.htm…

Continue reading

Asia

Donā€™t Ignore Statistical Trends In Asia

By Ames Gross

…demand from China, India, and ASEAN countries will more than compensate for this decrease in demand. Medical device companies should take note of these statistics as they look to expand…

…demand from China, India, and ASEAN countries will more than compensate for this decrease in demand. Medical device companies should take note of these statistics as they look to expand…

Continue reading

The Devil Is in the Due Diligence

By Thomas Maeder

companies. Here are five reasons you need to come to the program in Boston: Meet top level speakers who have been through it all Identify the hidden areas where problems…

companies. Here are five reasons you need to come to the program in Boston: Meet top level speakers who have been through it all Identify the hidden areas where problems…

Continue reading

Eric Luyer, Axendia
MEDdesign

Augmented Reality in Todayā€™s Operating Rooms

By Eric M. Luyer

…the procedure and why, and for checking compliance with regulations and to help settle any complaints. In line with the examples described above, virtual reality is another technology that can…

…the procedure and why, and for checking compliance with regulations and to help settle any complaints. In line with the examples described above, virtual reality is another technology that can…

Continue reading