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Roche Diagnostics Corp.

Division of Roche
www.roche-diagnostics.us

Latest From Roche Diagnostics Corp.

Global Device Approvals Snapshot: 25 June-1 July 2019

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 25 June to 1 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, or de novos. Japan’s MHLW approved Foundation Medicine’s companion diagnostic for Roche’s cancer drug Rozlytrek.

Approvals In Vitro Diagnostics

Veeva Eyes Opportunity In Medical Devices To Grow Cloud Technology Business

Cloud-based software company Veeva wants to grow its business in medical devices to meet industry demand for better data management systems. The company is already a major provider of software services to the pharmaceutical industry.

Compliance Life Cycle Management

EU No-Deal Scenario Looms Still, But MHRA’s Reg Oversight Of UK Medtech On Hold

UK parliament’s indecision over how – or if – to enact Brexit saw the planned March 29 withdrawal deadline come and go. The default positions of the inter-ministerial Office for Lifesciences (OLS) and health-care products regulator (MHRA) are still to prepare for a no-deal exit from the EU.

United Kingdom Brexit

Brazil Simplifies Class I Approvals To Focus On Higher-Risk Products

Brazil has passed legislation enabling class I (lowest risk) devices and diagnostics to gain market approval through a notification pathway rather than under the current review-based registration system. The move is essentially intended to help regulatory agency Anvisa refocus its efforts toward the higher-risk arena.

Brazil Medical Device
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