Medical tech industry stakeholders are showing mixed reactions to the FDA’s latest proposal for a system of unique device identifiers that can monitor medical devices for tracking and public health purposes.
AdvaMed
AdvaMed: MDUFMA III “isn’t your father’s user fee agreement”
The FDA user fee bill, which passed a final regulatory hurdle in the Senate last night, is a 3-way win for patients, medical device makers and the FDA, industry lobby AdvaMed’s president & CEO Stephen Ubl told reporters today.
Video: AdvaMed’s Nexon on pricing pressures in healthcare | MassDevice.com On Call
MASSDEVICE ON CALL — Things aren’t going to get any easier in the healthcare industry in the near future regardless of what the Supreme Court rules on the Affordable Care Act, AdvaMed executive vice president David Nexon says in an interview:
AdvaMed CEO Ubl calls on Senate to repeal the device tax | MassDevice.com On Call
MASSDEVICE ON CALL — Following the U.S. House of Representatives’ sweeping repeal of the impending 2.3% medical device tax, lobbying efforts have turned to urging the Dem-led Senate to follow suit.
As a Senate bill repealing the medical device tax languishes without Democratic support, some have speculated that repeal efforts are dead in the water, but AdvaMed president & CEO Stephen Ubl took to the opinion pages to urge the nation’s upper house to spike the levy.
Device Tax: House Ways & Means OKs repeal bill
The U.S. House of Representatives’ Ways & Means Committee swiftly passed a bill repealing the 2.3% medical device tax through a mark-up session today, voting 23 to 11 in favor of sending the bill to a floor vote.
Rep. Erik Paulsen’s (R-Minn.) "Protect Medical Innovation Act of 2011" won bipartisan support from committee members, according to a statement.
Telemedicine and the moon landing | MassDevice.com On Call
MASSDEVICE ON CALL — Telemedicine may look like a future technology, but NASA has been using it to handle astronaut health care since the 1960s.
In a brief presentation at this year’s TEDMED conference, host Jay Walker told the audience how the 1st men who walked on the moon were wired with telemetric sensors that were monitored by mission control back on Earth.
Medical device tax: Ohio’s industry pushes repeal while GOP group gets hyper-political
The medical device industry’s efforts to repeal an impending 2.3% tax on sales continue to run in high gear as Ohio’s med-tech industry discusses impacts with local legislators and a Congressional GOP group takes the rhetoric and runs with it.
Device tax: Nationwide efforts aim to repeal, relax impending levy
As the medical device industry creeps ever nearer the launch date for the dreaded medical device, stakeholders and advocates seem to be picking up their efforts to lobby for repeal.
Industry groups this month issued comments on an IRS draft tax code, alternatively calling for repeal and for mercy, while a pair of Pennsylvania legislators spent some time discussing the potential impacts with local device makers.
AdvaMed to IRS: “Be reasonable”
The medical device industry is asking the IRS to “be reasonable” when it determines a key pricing rule in the 2.3% medical device excise tax.
“AdvaMed urges treasury to instruct its agents to be reasonable in their audit of this issue and mindful of the data limitations which companies face,” the industry council wrote to the Internal Revenue Service and U.S. Treasury Dept. "This acknowledgement should extend to the challenges our industry faces in complying with the complex constructive pricing rules.”
MDUFMA: FDA user fee agreements survive partisan fray in the House
FDA user fee agreements are set to march toward approval without much partisan squabbling as members of Congress hope to avoid the political quicksand that accompanies election season.
A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals, posted just before the weekend, is heading toward approval without some of the controversial language that threatened to leave the bill in a partisan quagmire.
EXCLUSIVE: Masimo CEO Kiani on why the med-tech industry should protect its young
Masimo (NSDQ:MASI) founder and CEO Joe Kiani, in an exclusive interview with MassDevice.com, called for the medical device industry to be more pragmatic in its fight against the medical device tax, saying his med-tech colleagues should start thinking about ways to shield smaller companies from the impact of the levy.