Minnesota’s Medtronic (NYSE:MDT) announced today that it won expanded approval from the FDA for its SureScan line of pacemakers, labeling them as safe for undergoing full-body MRI scanning.
Food & Drug Administration (FDA)
St. Jude Medical quietly lands FDA approval for Cool Flex cardiac ablation
Medtech titan St. Jude Medical (NYSE:STJ) won FDA premarket approval for its Cool Flex cardiac ablation system with indication to treat irregular heart rhythms.
Senate OKs $1T omnibus budget deal, restoring FDA user fees
The U.S. Senate yesterday approved an omnibus, $1.012 trillion budget bill that includes the restoration of some $85 million in user fees from medical device and pharmaceutical companies that was held in abeyance by sequestration.
President Barack Obama, who has until midnight tomorrow to sign the measure into law, is expected to quickly add his signature after the 72-26 vote in the Upper Chamber.
FDA OKs Medtronic’s CoreValve implant
FDA Commisioner Hamburg: Driving innovation is a key part of our mission
By: Margaret A. Hamburg, M.D.
Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA’s responsibility to protect the public health – and always will be.
FDA dings Philips on InnerCool RTx component recall
AdvaMed lauds user fee return, new funding for FDA | MassDevice.com On Call
MASSDEVICE ON CALL — Medtech industry lobbying group AdvaMed offered high praise for the federal government’s 2014 omnibus appropriations legislation, which restored important funding for the FDA.
The bill returned to the agency about $85 million in collected user fees that had been locked away due to the federal sequester, funds that medical device and drug companies pay for applications for FDA review.
FDA mandates pediatric data requirements for new medtech applications
The FDA this month finalized a rule requiring more pediatric patient information from medical devices going through the premarket approval pathway, even if the products are intended for adults.
Setting the bar for blood glucose meter performance
By: Courtney Lias
Many of the nearly 19 million Americans diagnosed with diabetes must monitor their blood glucose (sugar) frequently throughout the day using an at-home meter to make sure that their blood glucose is within a safe range. The ability to measure blood glucose at home has given people with this serious and chronic condition the ability to better control their blood sugar and thus avoid potential complications.
Is Google working on a medical device?
Medtech approvals: FDA releases October 2013 PMAs
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 56
Summary of PMA Originals Under Review
Total Under Review: 50
Total Active: 19
Total On Hold: 31