FDA Policy/General

Product Approval Summaries

DEVICES

Cerapedics has received FDA approval of its PMA for i-FACTOR Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease.

FDA has cleared a Convergent Dental 510(k) for Solea, a CO2 9.3 micron dental laser for use in performing osseous tissue procedures. “With this expanded indication, Solea can be used to treat not only cavity preparations and soft tissue surgery, but also bone cutting, shaving, re-contouring and resection,” the company says. Solea’s osseous tissue clearance allows dentists to perform procedures ablating bone with speed, precision and less bleeding, it says, adding that patients may experience less post-operative discomfort and faster healing times.

FDA has approved an INVO Bioscience de novo petition to allow the marketing of the INVOcell, an intravaginal culture system for use in infertility treatment. The device is used for incubating eggs and sperm during fertilization of early embryo development. “Unlike conventional infertility treatments such as in vitro fertilization (IVF), where the eggs and sperm develop into embryos in a laboratory, the INVOcell utilizes the women’s vagina as a natural incubator to support embryo development,” the company says. In clinical studies, the INVOcell procedure produced pregnancy rates equivalent to traditional IVF treatments.

Reflexion Health has received FDA 510(k) clearance for its motion-tracking physical therapy tool, Vera. The digital medicine software system uses Microsoft Kinect technology to aid patients with musculoskeletal rehabilitation. It projects an avatar onto a screen, coaches and motivates patients to perform exercises at home, and tracks and reports back data to a physical therapist who monitors progress and optimizes therapy in real time.

HUMAN DRUGS

FDA has approved a Gilead Sciences NDA for Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for treating HIV-1 infection in adults and pediatric patients 12 years of age and older. Approval was based on data from 3,171 patients enrolled in four clinical trials, an agency release says.

FDA has approved a GlaxoSmithKline NDA for Nucala (mepolizumab) for use with other asthma medicines as maintenance treatment in patients 12 years and older. The drug is approved for patients who have a history of severe asthma attacks despite receiving their current asthma medicines, according to an agency news release. Nucala is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells, according to FDA. It is subcutaneously injected once every four weeks into the upper arm, thigh, or abdomen. It works by reducing levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma, it says.

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

Read more

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