Precedent from Amarin's off-label promotion victory covers devices too, especially those marketing a surrogate endpoint
A recent court ruling inhibiting the FDA from punishing Amarin for off-label promotion deemed truthful and non-misleading shook up the pharma world. The ruling was made for reasons "totally extrinsic to the definition of a drug," and its principles "definitely apply to medical devices," said attorney Coleen Klasmeier in an interview. She heads the food, drug and medical device regulatory practice team at Sidley Austin LLP.
Last year, FierceMedicalDevices debuted its list of top women in med tech. This year we'd like to make it even better. Please let us know who the most important women are in med tech, including medical devices and diagnostics.
None of the giant med tech acquisitions that have closed recently have resulted in a reduction in employee count yet. Not Medtronic-Covidien, Zimmer-Biomet, nor Becton Dickinson-CareFusion. But the rumors are already swirling on where all the anticipated cost savings and reduduncies will be found. That's according to the latest jobs data from EP Vantage.
We need your help to ferret out the best, most timely examples of med tech innovation. Who has ambition and the potential to make a real leap forward, while being wildly appealing to physicians, patients and payers across a global healthcare environment that is increasingly value-based?
Bioabsorbable stents are projected to account for 17% of global procedure volume by 2021, up from less than 2% in 2014, said GlobalData analyst Amen Sanghera during a recent webinar. He's a bull on the emerging technology, and estimates a compounded annual growth rate of 56.7% over that time period.
Advice for med tech entrepreneurs: Identify your customer and consider stakeholders' incentives carefully
The med tech ecosystem is diverse and teeming with myriad stakeholders, to the point that identifying the customer of a company or device can be challenging. Successfully creating a new company in med tech means identifying the customer and then finding a way to meet that group's needs.
Margaret Hamburg gave a forceful recounting of her tenure at the agency in her final formal remarks as outgoing FDA commissioner. The March 27 speech at the National Press Club in Washington, DC, seemed designed to hand the baton off smoothly to FDA Chief Scientist Stephen Ostroff, who has been widely cited as her presumptive replacement.
In a show of force, the Department of Justice just announced two fines against providers for healthcare fraud under the False Claims Act totaling more than $10 million. The news coincided with release of an annual report on healthcare fraud, which claims that the feds recovered $3.3 billion in fiscal year 2014.
The FDA is putting robot assisted surgery in the spotlight this summer.
A little more than a month after Medtronic closed its $49.9 billion purchase of Covidien, the combined company is forging ahead with ambitious plans for growth. And as Medtronic's chief integration officer, Geoff Martha, told FierceMedicalDevices, the company's "first and foremost strategy" involves developing new devices to support innovative therapies, ultimately cutting costs and making healthcare more efficient.