FDAnews Device Daily Bulletin

The medical device industry remains largely unprepared for the risk posed to technology by malware and computer viruses, one computer security expert says.

Organizations that audit device establishments must ensure that their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum.

Medical entrepreneurs who have survived the downturn now face a new challenge: expanding their business amid the uncertainty created by health-care reform.

A California medical device company developing an automated glucose monitoring system for critically ill patients in the intensive care unit raised $5 million, according to two regulatory filings in October.

The rising incidence of acute cardiac rhythm-related disorders is prompting device manufacturers to innovate their cardiac rhythm management devices.

X-spine Systems received FDA approval for two spinal implants, advancing the company as a full-line spinal system provider.

The Johns Hopkins University hit biotechnology company Life Technologies with an infringement suit in North Carolina federal court, accusing the company of ripping off the school’s patented gene sequencing technology.

Medtronic Inc. has completed its $816 million acquisition of Chinese orthopedic device provider China Kanghui Holdings.