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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-58/
- Published: 2016-05-15T12:00:00.000Z
- Updated: 2026-09-14T21:02:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135679

**DEVICES**

**Bone Index Ltd.** has received 510(k) clearance from FDA for the Bindex point-of-care instrument to help in osteoporosis diagnosis. According to the company, Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA x-ray machines. It says Bindex detects osteoporosis with 90% sensitivity and specificity.

FDA has cleared a **CareTaker Medical** 510(k) for its Beat-by-Beat Blood Pressure and Heart Rate Monitor. The wearable device uses the company’s Finger Cuff technology to allow uninterrupted wire- and electrode-free vital signs monitoring “throughout the full mobile continuum of care; within the clinic and hospital, during patient transport, and remotely after patient discharge,” the company says. It also uses a Pulse Decomposition Analysis technology to measure blood pressure and heart rate, which are remotely displayed on the CareTaker secure Web portal or other wireless devices.

**EndoGastric Solutions** has received FDA 510(k) clearance for the EsophyX Z device for treating gastroesophageal reflux disease using transoral incisionless fundoplication. “Designed for compatibility with the company’s existing 7.5 mm SerosaFuse Implantable Fastener cartridges, the device allows physicians to reconstruct the gastroesophageal valve and then secure tissue with a trigger-like handle, making the device similar to stapler like devices often utilized in surgery,” the company says.

FDA has approved an **Integra LifeSciences** PMA for its Omnigraft Dermal Regeneration Matrix, indicated for use in treating partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.

FDA has cleared a **NinePoint Medical** 510(k) for the Real-time Targeting feature for its NvisionVLE Imaging System. The company says the device uses its Optical Coherence Tomography technology to allow physicians to perform Volumetric Laser Endomicroscopy (VLE) procedures, producing real-time, high-resolution cross-sectional images to help gastroenterologists evaluate tissue for potential disease that may not be visible with conventional medical imaging technologies, such as endoscopy and ultrasound.

**Xtant Medical Holdings** has received FDA 510(k) clearance for a posterior cervical screw indication on the Certex Spinal Fixation System, which the company says can be linked to the Fortex Pedicle Screw System and the Xpress Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods. “This extended use of Certex screws in the cervical spine enhances stability for posterior cervical procedures allowing an opportunity to increase fixation options to promote fusion,” Xtant Medical says. The Certex Spinal Fixation System is also intended to assist in restoring spinal column integrity for a limited time in the absence of fusion in patients with advanced stage tumors involving the cervical spine in whom life expectancy is medically determined to be insufficient to permit achievement of fusion.

**HUMAN DRUGS**  
  
**Eisai Inc.** has received FDA approved Lenvima (lenvatinib) in combination with everolimus for treating patients with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy.

FDA has approved an expanded label for **Janssen**’s Imbruvica (ibrutinib) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approved label now includes overall survival data from the Phase 3 RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL patients 65 years or older. It also contains clinical data from the Phase 3 HELIOS (CLL3001) trial investigating the use of Imbruvica in combination with bendamustine and rituximab versus placebo plus rituximab in patients with relapsed or refractory CLL/SLL.

**Teligent, Inc.** has received FDA approval of an ANDA for triamcinolone acetonide ointment USP, 0.1%, indicated to used to treat a variety of skin conditions (eczema, dermatitis, allergies, rash).

FDA has approved a **Theravance Biopharma** supplemental NDA for Vibativ (telavancin) to expand the antibiotic’s label to include data describing the treatment of patients with concurrent Staphylococcus aureus bacteremia in both currently approved indications. Vibativ is approved in the U.S. for treating adult patients with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, it is approved for treating adult patients with complicated skin & skin structure infections caused by susceptible isolates of Gram-positive bacteria, including *S. aureus*, both methicillin-susceptible and methicillin-resistant strains.