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MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

 
• By Sue Darcey and David Filmore

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

[Editors' note:Follow progress with legislation impacting the device and diagnostics industry with Medtech Insight's US Congress Tracker.]

President Trump quietly signed the FDA Reauthorization Act Aug

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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

SS Innovations Files For De Novo For SSi Mantra 3 Surgical Robotic System For Multispecialty Indications

 
• By Marion Webb

SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.