The objective of this analysis was to assess whether timelines associated with the De Novo Process are in line with FDA’s stated goals.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
“Medical Compliance in a Box” provides insights and valuable information to manufacturers seeking market access in North America and the European Union
Intertek, a leading global provider of quality and safety solutions, announces the availability of a unique two-day seminar for medical device manufacturers. Titled “Medical Compliance in a Box,” the seminar introduces manufacturers to the regulations and opportunities that occur throughout the medical device product life cycle, particularly for the North American and the European Union markets.
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended June 4 closed at 5.75, down 1.6 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 29.8 percent.
Salt Lake City, March 2, 2010 – Amedica Corporation, a spinal and orthopaedic implant and instrument company focused on unique silicon nitride (SiN) ceramic technologies, announced today that it has been granted United States Patent No. 7,666,229 covering its novel ceramic-on-ceramic bearings for articulating joints used for total joint replacement and spinal disc applications. Currently under development, Amedica’s new advance bearing surfaces covered under this and other pending patents will be used as ultra-low-wear bearing components for motion preserving implants.
MassDevice and the Institute for Technology Entrepreneurship & Commercialization at Boston University’s School of Management held the first annual World Health Medical Technology Conference May 17, 2010. Creating a business model that helps solve the global problem of providing healthcare to the planet’s poorest people dominated the presentations and discussions of the day-long event. One out of every four people worldwide lives on less than $1.25 a day, and bringing advanced, or even adequate, healthcare to them may not seem feasible.
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended May 28 closed at 5.84, up 2.5 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 31.9 percent.
In the life sciences industry, many companies have a heightened sensitivity to risk due to increased regulatory scrutiny and/or product quality issues. As a result, the concern around compliance has renewed many organizations’ focus on audit programs, which are being re-calibrated as a tool to identify the most vulnerable parts of the business.
Last month was the 18th anniversary of Sam Kinison’s death. Kinison, a former revival preacher, was known for his fire and brimstone comedic delivery and trademark scream. I was thinking of the late great comedian recently while writing a capabilities piece for our agency — an e-doc on how we’ve helped clients build a stronger web presence. It seems to me Kinison’s classic bit on solving world hunger offers an important lesson on the topic:
Our Weekly Checkup takes the temperature of the medical device industry’s three largest U.S. clusters: Massachusetts, California and Minnesota.
The MassDevice Indices are weighted according to market capitalization, based on the number of shares outstanding for each company and each Friday’s closing share price.
The Massachusetts index for the week ended May 21 closed at 5.70, up 40.2 percent compared with the prior week. Since Jan. 1, 2009, when we began tracking these companies, the index has risen 28.7 percent.
Virtual Radiologic Corp. (NSDQ:VRAD) is heading private in a $294 million acquisition, three years after its $68 million IPO.
Rhode Island-based private equity firm Providence Equity Partners agreed to buy out the radiology outsourcing firm, according to a press release (PDF).