Neural Analytics Receives CE Mark for the Lucid System January 25, 2017 The battery-operated ultrasound device monitors blood vessels in the brain. Read More
FDA Cites 22 Failed Trials in Report, Making the Case for the Phase III Gold Standard January 25, 2017 The agency restated the importance of maintaining the gold standard. Read More
Prescient Surgical Achieves FDA De Novo Clearance for CleanCision System January 24, 2017 The company plans to launch the CleanCision device in 2017. Read More
Congress Receives FDA’s User Fee Reauthorization Recommendations January 24, 2017 Lawmakers must pass legislation reauthorizing the three laws before Oct. 1. Read More
FDA, Health Canada Clear 7D Surgical’s Image Guidance System January 23, 2017 The device removes vision barriers during spinal surgery. Read More
FDA Outlines Examples of Communications Consistent with Approved Labeling January 23, 2017 Sponsors can disclose information on the safety and efficacy profile of a drug. Read More
Bill With Bipartisan Support Would Repeal Device Tax January 20, 2017 The bill would make permanent a two-year suspension of the tax. Read More
FDA Urges Sponsors to Minimize Design Changes in Generic Drug Delivery Products January 20, 2017 The agency may accept design differences if they are adequately analyzed and scientifically justified. Read More
Australia’s TGA Issues Alerts for Medtronic Defibrillators January 19, 2017 Consumers report problems with reprogramming commands. Read More
FDA Issues Guidances Outlining Exemptions for Repackaging Products January 19, 2017 Products cannot be combined with a bulk drug substance. Read More
FDA Grants Marketing Clearance to CyMedica Orthopedics’ Wireless Muscle Stimulation Device January 18, 2017 The device can be controlled with your smart phone. Read More
FDA Records Second Highest ANDA Submissions Under GDUFA I January 18, 2017 Submissions reached a peak in June 2014. Read More