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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-99/
- Published: 2019-07-14T12:00:00.000Z
- Updated: 2026-09-15T01:37:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5132273

**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.