MedTech

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Life Sciences Venture Capital Investment Soars to Record High

 Venture capital (VC) funding for the Life Sciences sector, which includes Biotechnology and Medical Devices, reached $2.5 billion in 195 deals for the second quarter of 2014, according to a new report, “Biotech soars to record high,” which includes data from the MoneyTree™ Report from PricewaterhouseCoopers (PwC) LLP and the National Venture Capital Association (NVCA),…

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Medical device patent law: Experts discuss what you should know

Originally posted on MedCity News The patent protection landscape’s been turned on its head in the past couple years, ever since the Leahy-Smith America Invents Act went into effect. A discussion at trade group Biocom’s DeviceFest in San Diego this week addressed some of these changes and subtleties as they apply to medical device companies:

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FDA simplifies process for novel medical devices

Truly innovative devices that do not have a “substantially equivalent” predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply…

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The Sunshine Act: Promising Clarity & Providing Confusion

The logic behind the Sunshine Act says that providing clarity on any money that pharma and device makers pay to doctors and hospitals will reduce the occurrence or appearance of corruption. . The idea is that by making those payments a matter of public record makes it undesirable for companies to try to influence medical experts.

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