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Global Device Approvals, Weekly Snapshot: Aug. 6-12, 2018

Executive Summary

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, a new microstent for glaucoma was approved by US FDA.

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US FDA announced the approval of the first direct-to-consumer mobile medical app that can prevent pregnancy via fertility awareness tracking. The app, Natural Cycles, has been criticized in Europe after some users experienced unplanned pregnancies. On the same day, the agency approved the first contraceptive vaginal ring that can be reused for an entire year.

Market Intel: Micro-Invasive Glaucoma Implants Mark Hottest Growth Spot In Eye Surgery Products Market

The rising aging population and ever-increasing incidences of glaucoma and cataract are clearing a bright path for the ophthalmic surgical products market, which is expected to reach $9.4bn by 2021, a CAGR of 4.6% from 2016. Meddevicetracker expects that continued innovation in minimally invasive technologies and next-generation surgical systems, developed by giants like Alcon and smaller rivals, will address the need of hundreds of millions of people suffering from cataract and glaucoma, the two leading causes of blindness globally. In this feature, we'll take a closer look at the overall market and the key players in the individual segments of surgical systems, surgical instruments and IOLs. We'll take a deep dive into the smallest, yet fastest-growing MIGS devices segment and talk to surgeons about how they're transforming glaucoma management for their patients.

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

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