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Essure Panel Stresses Need For Patient Follow-Up, But Stressed-Out Patients Say, ‘Recall It’

An FDA advisory panel recommended a collection of activities to mitigate risk in the use of Bayer Healthcare’s Essure permanent contraceptive device, but dozens of patients describing hypersensitivity, extreme pain, insert migration, irregular bleeding, ectopic pregnancy and perforation events urged FDA to recall the device.

More information about risks linked to Bayer HealthCare LLC ’s Essure permanent female sterilization device and about potential removal of the device needs to be provided to patients and physicians, FDA advisors said Sept. 24.

The agency's Obstetrics and Gynecology Device Advisory Panel met at FDA's Silver Spring, Md

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UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

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.