FDA Policy/General

Product Approval Summaries

BIOLOGICS

FDA has approved Bayer’s Kovaltry (antihemophilic factor-recombinant), a factor VIII compound for treating hemophilia A in children and adults. The approval is based on data from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which demonstrated the therapy’s supported safety and effectiveness for routine prophylaxis to reduce bleeding episode frequency, according to the company.

DEVICES

FDA has cleared a CardiacAssist 510(k) for its TandemLung oxygenator, a device that acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood. It uses a radial flow design coupled with advanced polymethylpentene fibers to transfer oxygen into the blood for patients requiring cardiac or respiratory support, according to the company. It is intended for use in adult patients for extracorporeal circulation during cardiopulmonary bypass for up to six hours. bypass for up to six hours.

InfoBionic has received FDA 510(k) clearance for MoMe Kardia, a wireless, remote monitoring system designed to aid physicians in diagnosing cardiac arrhythmias in patients with a demonstrated need for such monitoring. The three-in-one device transitions between Holter, Event and Mobile Cardiac Telemetry modes remotely, which is intended to streamline patient monitoring time without delays, according to the company. It uses a cloud-based proprietary platform to deliver on-demand data and analytics directly to a patient’s physician.

Intuitive Surgical has received FDA approval for its da Vinci Xi Single-Site instruments and accessories. The company says the Single-Site technology helps surgeons operate through a single incision in the patient’s umbilicus during cholecystectomy, benign hysterectomy and salpingo-oophorectomy procedures, which will lead to an almost scar-less surgery.

FDA has cleared a PneumaCare 510(k) for its Thora-3DI imaging device, intended for use in measuring breathing. The device uses structured light plethysmography to measure breathing by detecting movement in the chest and abdomen. It can be used to measure respiratory status in patients with a range of respiratory conditions, including asthma, chronic obstructive pulmonary disease, pneumonia and lung failure, and to assess patients before and after surgery, according to the company.

HUMAN DRUGS

Spectrum Pharmaceuticals has received FDA approval of Evomela for use in two indications: use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

VETERINARY

Aratana Therapeutics, Inc. has received FDA approval for Galliprant (grapiprant tablets) for controlling pain and inflammation associated with osteoarthritis in dogs.

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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