FDA Policy/General

Product Approval Summaries

DEVICES

AliveCor has received FDA approval for its AliveECG app, which can run an algorithm that detects atrial fibrillation. The company says the app runs on a smartphone and the patient places their hand over an AliveCor nodule device that fits over the back of the phone. It says the app then measures the electric signals being transmitted by the heart and radiating through the fingers, detected by the nodule.

FDA has cleared Intuitive Surgical’s Firefly Fluorescence Imaging for the da Vinci Xi Surgical System, which the company says provides surgeons with enhanced visualization during minimally invasive surgical procedures. Firefly Imaging enables real-time visual assessment of vessels, blood flow and related tissue perfusion and assessment of the major ducts that connect to the gallbladder for transport of bile, according to the company. Also, it says, Firefly enables surgeons to switch between standard, visible light and near-infrared imaging during minimally invasive procedures.

Oxford Performance Materials has received FDA 510(k) clearance for its 3D printed OsteoFab Patient-Specific Facial Device. The company says for printing of the device, it will utilize its OsteoFab process, a combination of laser sintering additive manufacturing technology and the powder formulation Oxpekk, which creates implants that are mechanically similar to bone and therefore support bone attachment.

FDA has granted marketing approval of Kronus’ Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay, the first ZnT8Ab test to help determine if a person has Type 1 diabetes. According to the company, it detects the presence of ZnT8Ab in the patient’s blood sample, which is produced in the immune system of many patients with Type 1 diabetes, but not in those with other types.

HUMAN DRUGS

FDA has approved Biogen Idec’s Plegridy injectable, as a longer-lasting treatment for patients with relapsing-remitting multiple sclerosis.

Genzyme has received FDA approval of an NDA for Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease. The drug slows down the production of fatty materials by inhibiting the metabolic process that forms them, according to an agency release.

FDA has approved GlaxoSmithKline’s Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for maintenance treatment of asthma as prophylactic therapy in patients age 12 and older. The company says that Arnuity is not indicated for relief of acute bronchospasm. The approved doses of 100 mcg and 200 mcg are administered once daily through the Ellipta dry powder inhaler, which is also used in some other approved GSK respiratory drugs.

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