Aduro Biotech, InfaredX, OpGen and Carbylan Therapeutics all were talking IPO yesterday - some good news and some not so good news, depending on your point of view. Also, Margaret Hamburg's got a new job. Read the summary of the last 24 hours in the business of healthcare with our Morning Read.
Serious U.S. regulatory lags are driving the medical device business to Europe – with startups, clinical trial sites and market approvals all migrating eastward at a rapid clip. At the same time, the Food and Drug Administration has stated it has the vision for the U.S. to be the world’s leader in medical device innovation and manufacture. […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
So, it’s true. The top 2 spots in Modern Healthcare’s 2014 list of the 100 most influential people in healthcare are black men. If you look at the top 10, there are two white women. The remaining 6 people are white guys. If you look at who makes the most money, it’s a much more […]
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]
President Barack Obama’s proposed 2014 budget includes an increase of $3.9 billion to implement the Affordable Care Act, with $1.5 billion of that going to support the launch of health insurance exchanges. Health and Human Services Secretary Kathleen Sebelius said that this figure would cover both outreach to support enrollment and building the federal exchange. […]
Pharmaceutical and medical device companies have long grumbled about the U.S. Food and Drug Administration‘s process for getting new products approved. Some say it’s too long. Others say it’s restrictive. Many say it’s just not clear. FDA Commissioner Dr. Margaret Hamburg heard many of those concerns in person during a visit to North Carolina’s Research […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The federal watchdog agency is pitching Congress and President Barack Obama for $4.3 billion for fiscal 2012, about a third more than it got in 2010. The FDA's fiscal 2011 request was for $4.03 billion, a 23 percent increase over 2010.
Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).
Dr. Margaret Hamburg looks to quell concerns about the Food & Drug Administration’s plan to reshape the 510(k) medical device clearance process. Food & Drug Administration chief Dr. Margaret Hamburg told a gathering of medical device industry leaders that her agency’s plan to revamp the 510(k) clearance process will take account of any “substantive concerns” […]
Minnesota’s medical device community has enlisted some big guns to lobby the Food and Drug Administration against proposed changes that the industry says will hurt innovation and the state’s economy: United States Sen. Amy Klobuchar and Congressman Erik Paulsen. In a letter to FDA Commissioner Dr. Margaret Hamburg, Klobuchar, chair of the Senate Commerce Subcommittee […]
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