WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction in the U.S. Senate of legislation (S. 1183) to streamline FDA’s medical technology review process:
Press Release | May 19, 2017
Press Release | May 18, 2017
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction of legislation (H.R. 2474) in the U.S. House of Representatives that would create an alternative review approach for low- to moderate-risk medical devices and diagnostics:
Press Release | May 18, 2017
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction in the U.S. House of Representatives of legislation (H.R. 2483) to streamline FDA’s medical technology review process
June 6, 2017 to June 7, 2017| Minneapolis, MN
Maintaining effective design control procedures is a key element of the quality system regulation. This interactive workshop takes attendees step by step through all aspects of design control,... Read More
June 14, 2017 | Virtual
Recalls bring a unique set of questions, goals and demands to each stakeholder – from urgency, to control of the narrative, building a strategic deployment plan, overtaxing the... Read More
Medical technology aids in the prevention, diagnosis and treatment of various conditions to enhance quality of life and help you enjoy more of life's precious moments.
Often undiagnosed, an estimated two to six million people in the United States have a serious heart condition called atrial fibrillation, or AFib. As those living with the disease know, complications from the irregular heartbeat caused by the AFib can be potentially devastating: The average person with AFib is five times more likely to suffer a stroke than someone with a regular heartbeat. Fortunately, there is innovative medical technology available today poised to make a real difference in...
WLF: Medical-Device Makers’ Representatives in the O.R.: Patient-Care Benefits and Legal Ramifications
When a doctor implants a medical device, he or she often requests the presence of a representative of the device manufacturer (a “rep”) in the operating room. Some observers are critical of this practice, demanding thatreps be barred from the O.R. At the same time,some lawyersthink repsin the O.R.should be subject to liability in the court system. This Legal Backgrounder explains why reps often play an important, if limited, role in the O.R., and why that role should not expose reps to lawsuits
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced today the closing of a $36 million Series C financing, including existing convertible notes. The round was led by Philips and UPMC, through its innovation and commercialization arm UPMC Enterprises, with other new and existing investors participating. The funding will support a planned US-based pivotal trial for...
Imagine for a moment that you are one of the approximately 44 million women in the U.S. affected by cardiovascular disease, or one of the 24 million with osteoarthritis. You'd want access to the most advanced and effective care. Oftentimes, your doctor would recommend a medical technology or device as an essential component of your treatment – placing a stent in a blocked artery or replacing your knee or hip with a new artificial one, for example.
Mar. 09, 2017 - AdvaMed CEO Scott Whitaker discusses the impact of the medical device tax on business.