News from the FDA/CDC
News from the FDA/CDC
FDA OKs Paradise Renal Denervation system for hypertension
The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the...
News from the FDA/CDC
FDA okays first extravascular ICD system
“Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications ...”
News from the FDA/CDC
FDA denies approval for patisiran in ATTR cardiomyopathy, despite panel nod
The FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have...
News from the FDA/CDC
Patisiran (Onpattro) for ATTR cardiomyopathy gets FDA panel thumbs up
The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and...
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FDA to step up oversight of cosmetics, assess ‘forever chemicals’
The cosmetic products include makeup products, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair...
News from the FDA/CDC
FDA panel split on efficacy of Spyral renal denervation system
The Symplicity Spyral system provides a catheter-based approach to denervate the renal arteries using radiofrequency energy.
News from the FDA/CDC
ReCor renal denervation system safe, effective: FDA panel
Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of...
News from the FDA/CDC
Recall for Impella RP Flex labeling short on safety cautions
The devices themselves are not part of the recall; clinicians may continue to use them, the FDA says.
News from the FDA/CDC
Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a...
News from the FDA/CDC
FDA: No excess mortality risk from paclitaxel stents, balloons for peripheral intervention
“The updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
News from the FDA/CDC
FDA approves first leadless dual-chamber pacing system
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study.