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Theranos, a hot startup that recently received media scrutiny regarding its testing system, has been hit with two 483s, one of which takes the company to task for shipping an uncleared device. Read More
The China Food and Drug Administration has issued four guidelines that provide additional information for devicemakers awaiting good manufacturing practices inspections. Read More
In the wake of more than 5,000 adverse events reports, including four deaths, the FDA says it plans to communicate next steps it plans to take on Bayer’s Essure contraceptive implant by the end of next February. Read More
The FDA is re-proposing classifying in vitro diagnostic devices for Bacillus species detection into Class 2 with special controls, a move the agency says would help assure the safety and effectiveness of the devices. Read More
A Texas man who owned two Houston-area durable medical equipment companies must serve five years and three months in prison and pay $1.96 million in restitution for his role in a scheme to defraud Medicare, the U.S. Department of Justice announced. Read More
A bipartisan group of 44 freshmen members of Congress is urging House Speaker Paul Ryan (R-Wisc.) to include medical device tax repeal provisions in a larger legislative package by the end of the calendar year. Read More
The Irish Medical Devices Association has laid out an ambitious set of priorities it hopes to see acted on by the next government to maintain the country’s competitiveness in the medtech sector. Read More
Shrugging off complaints that it is hindering innovation, the FDA is looking into whether five companies are selling unapproved diagnostic tests. Read More
Calling it a first for Japan, Cyberdyne has revealed that the country’s Ministry of Health, Labour and Welfare has approved the HAL for medical use, a robotic therapeutic device to improve patients’ walking function. Read More
Australia’s Therapeutic Goods Administration is updating guidance materials on in vitro diagnostic medical devices, following new amendments to the regulatory framework. Read More
Facing members of the Senate’s Committee on Health, Education, Labor and Pensions last week, Robert Califf, President Barack Obama’s choice to head the FDA, defended his record, emphasizing he would not lower standards for device approvals. Read More