AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]
Food & Drug Administration (FDA)
FDA panel supports Claret Medical’s Sentinel, despite efficacy questions
UPDATED Feb. 27, 2017, with reaction from Claret Medical. The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device. The Santa Rosa, Calif.-based company’s Sentinel device is designed to use a pair of temporary arterial filters during […]
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT(NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. Get the full story at […]
E-Qure wins FDA nod to expand chronic wound treatment device trial
Chronic wound treatment device developer E-Qure said today it won FDA approval to expand and launch a pivotal trial of its Bio-electrical Signal Therapy Device chronic wound treatment device. The New York-based company said its Bio-electrical Signal Therapy device is designed for non-invasively treating hard-to-heal chronic wounds, including pressure ulcers, diabetic foot ulcers, venous stasis ulcers and […]
FDA won’t do that: Cybersecurity edition
The medical device industry should not treat cybersecurity as though it were a check box—and they may want to brush up on FDA’s role, says Seth Carmody, PhD, cybersecurity program manager at FDA. Speaking this week during an HIMMS 2017 education session, Carmody warned that the clinical environment “represents a large attack surface for national security […]
Teleflex wins FDA nod for Trapliner cath, sees shares rise on Street-topping Q4, FY2016 earnings
Teleflex (NYSE:TFX) today said it won FDA 510(k) clearance for its TrapLine Catheter and saw shares tick up upon the release of 4th quarter and full fiscal year 2016 earnings that beat expectations on The Street. The company’s TrapLine catheter was developed by Vascular Solutions, which Teleflex officially acquired last week. The TrapLiner is intended for use in conjunction with guide […]
Seventh Sense Biosystems wins FDA nod for blood collection device
Seventh Sense Biosystems said today its Tap blood collection device won FDA 510(k) clearance. The company’s push-botton device collects capillary blood for hemoglobin A1C testing without the use of large needles. The Tap device is designed to be placed on the upper arm and blood collection, which takes 2 to 3 minutes, begins with a […]
FDA accepts Ocular’s NDA resubmission for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval […]
Actamax seeks FDA nod for sprayable adhesion barrier trial
Actamax Surgical Materials, a DSM-DuPont joint venture, said today that it submitted an Investigational Device Exemption application to the FDA for its adhesion barrier device in gynecological laparoscopic surgery. Adhesions, excessive scar tissue that can form between adjacent internal tissues, are a result of normal wound healing. Adhesions occur post-surgical operations at rates of 50-90%. […]
7 medtech stories we missed: Feb. 17, 2017
Several companies released diabetes study results this week, while companies like BioTime closed on their public offerings and Pixium implanted its first bionic eye. Here are 7 medtech stories we missed this week, but were still worth mentioning. 1. Insulet touts glucose control study Insulet Corp. announced the results from its first feasibility study of its Omnipod […]
FDA: Zimmer Biomet recall of Comprehensive Reverse Shoulder System is Class I
The FDA this week released information on a Class 1 recall of Zimmer Biomet‘s (NYSE:ZBH) Comprehensive Reverse Shoulder System over issues with the devices fracturing. The Warsaw, Ind.-based company’s Comprehensive Reverse Shoulder system is a shoulder replacement device designed to be surgically implanted to restore arm movement in patients with rotator cuff tears who have […]