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FDA

Latest Headlines

Latest Headlines

FDA launches probe into safety of common MRI contrast agent

Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.

FDA recall notice issued for nearly 2,000 Medtronic MiniMed insulin pumps

Medtronic disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just made by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.

Will marketing make the difference in approval of Sprout's 'pink pill' for women?

In the next few weeks, the FDA will rule again on a prescription treatment for female sexual dysfunction. This is the third time the FDA has considered Sprout Pharmaceuticals' drug flibanserin, which has been rejected twice. This time, however, it has its best chance yet of getting approved, having already gained an FDA advisory panel nod in June.

Startup partners with AstraZeneca on smart inhalers ahead of Aussie IPO

Melbourne, Australia-based Adherium has pulled off a major pharma partnership just ahead of a proposed listing on the Australian Stock Exchange. It expects to list on Aug. 26, raising up to $35 million and at least $20 million. A new deal that the smart inhaler player just disclosed with AstraZeneca can only enhance its public market prospects.

Gynesonics gets $43M to back pivotal trial of uterine fibroid ablation device

Gynesonics has received $43 million from investors to support the clinical development of its Sonata System, which uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance in a transcervical procedure that preserves the uterus.

'Cures' bill, designed to speed drug approvals, could be too much of a good thing, dissenters say

The FDA has made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers has attracted a chorus of critics worried that it could go too far at the expense of patients.

UCLA adopts startup cleaning system to help stop spread of superbugs via duodenoscopes

Upstart Langford IC Systems claims that it's launching the only system that meets FDA standards for reprocessed medical device cleanliness. Its first buyer is the Ronald Reagan UCLA Medical Center in Los Angeles, which reported two patient deaths and several infections earlier this year due to insufficiently disinfected duodenoscopes, which are a type of endoscope for examining the duodenum.

FDA approves Abbott 3-D Lasik system to improve accuracy, expand indication

The U.S. Food and Drug Administration has approved the iDesign Advanced WaveScan Studio System from Abbott Laboratories. The company has already launched the system, which is based on a 3-D map of the eye that's expected to improve the accuracy of Lasik procedures.

FDA turns to Google for help spotting adverse events

The FDA has approached Google for help identifying adverse drug events in search data. The regulator hooked up with Google to access the insights of Evgeniy Gabrilovich, an engineer at the tech behemoth who has published papers on the subject of mining search queries for adverse event reports.

NYT op-ed slams device breakthrough pathway proposed in 21st Century Cures Act

The 21st Century Cures Act promises to overhaul regulation of the medical device (and biopharma) industry if it passes the Senate. It just passed in the House of Representatives with a strong bipartisan majority. One of the main ways in which it would benefit the device industry is through the creation of a "breakthrough" pathway for critical medical devices.