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Surgalign Pays $2M To Resolve SEC Investigation

Executive Summary

US financial regulators said that the spinal device company falsely attributed future sales to the current quarter as a way to disguise lower-than-expected sales.

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MDSAP Audit Allows Emerging Firm To Expand Internationally

Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight

FDA’s Power Morcellation Containment System Guidance Doc Finalized

The US FDA has finalized a guidance document that details performance assessment standards for power morcellation containment systems. The class II devices have been an object of special scrutiny since the agency learned that power morcellation could spread cancerous tissue throughout the body.

EPA Gives Stakeholders Additional 15 Days For EtO Comments

The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June. 

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