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US Policy Quick Bits: Tax Reform, Sen. Franken, And 3D-Printing

 
• By David Filmore

A concise look at key US policy developments and events that unfolded over the past week, including tax reform, an update on Sen. Franken, and important policy-development updates at US FDA.

Capitol House

Tax-reform cometh: The Senate passed its closely watched tax overhaul Dec. 2, and Republican leaders in Congress are putting together conference committees to hash out a final bill to send to the president. The plan would lower corporate tax rates significantly, but also includes some provisions not as positive for the medtech space.

Pressure on Franken builds: A group of more than 11 Senate Democrats on Dec. 6 asked frequent device-industry supporter Sen....

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• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

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