FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared an InvisionHeart 510(k) for its Invision ECG System that is intended to provide a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic-quality electrocardiograms. T

FDA has cleared RegenScientific’s Renu Gel injectable implant, a resorbable buffered hydrogel indicated for vocal fold injection augmentation in patients with suspected vocal fold paresis, or as a trial vocal fold injection augmentation prior to selecting a long-term augmentation therapy.

Roche has received FDA 510(k) clearance for the cobas Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens. The test targets the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients. “The cobas 4800 System has the capability to allow for mixed batch testing of the cobas Cdiff Test alongside testing for methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and herpes simplex virus 1 and 2, all on one platform,” the company says.

FDA has cleared a SurgiQuest 510(k) for the AirSeal System and its use in transanal endoscopic surgery (TES). The device can be used in both transanal minimally invasive surgery and transanal total mesorectal excision, a surgical technique that has been shown to significantly improve patient outcomes in colorectal cancer procedures, it says.

Verax Biomedical has gained FDA clearance to expand the use of its Verax Platelet PGD test—a rapid test for the detection of bacterial contamination in platelets intended for transfusion. The test was first cleared by FDA in 2007 for detecting bacterial contamination in leukoreduced apheresis platelets and in 2009 for use with whole-blood derived platelets.

VertiFlex has received FDA approval of a PMA for the Superion Interspinous Spacer System, indicated for moderate lumbar spinal stenosis.

HUMAN DRUGS

FDA has approved a Boehringer Ingelheim NDA for once-daily Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray, indicated as a long-term, once-daily maintenance treatment for airflow obstruction in patients with chronic obstructive pulmonary disease

FDA has approved Wyeth Pharmaceuticals’ Rapamune (sirolimus) for treating lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome