The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation. The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
Two deaths reported in recall of 6 million Teleflex endotracheal tubes
Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA. Each of the more than 6 million recalled tracheal tubes includes an appropriately sized […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up to 30 days […]
FDA clears Life Spine’s surgical spacer system
Life Spine said that the FDA has granted 510(k) market clearance for the company’s Prolift lateral expandable spacer system. The system features minimal insertion height and controlled, in situ expansion, which are critical components in a minimally invasive expandable lateral interbody fusion procedure, according to the Huntley, Ill.-based company. “The Prolift lateral expandable spacer system […]
Gel-e gains breakthrough device nod for internal bleeding control device
Wound-care startup Gel-e said today that it has won FDA breakthrough status designation for its first internal-use flowable device. The College Park, Md.-based company’s first product, Life Foam, is an expanding, injectable hemostat designed to rapidly provide temporary control of bleeding from non-compressible abdominal wounds that are not suited to tourniquet application in trauma and battlefield […]
Apollo Endosurgery updates labeling on intragastric balloon
Apollo Endosurgery (NSDQ:APEN) said today that the FDA has approved its proposed labeling updates for the Orbera intragastric liquid-filled balloon system, which is used to treat obesity. The goal of the labeling updates is to improve patient safety and they will take effect immediately, according to the Austin, Texas-based company. The Orbera system and Reshape […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
Itamar Medical lands FDA clearance for disposable sleep apnea test
Itamar Medical (TASE:ITMR) said that its WatchPAT One fully disposable home sleep apnea test has received FDA 510(k) clearance. The device may save clinics time and money because it does not need return shipping, downloading, cleaning or preparation for the next study, according to Caesarea, Israel-based Itamar. “WatchPAT One is ideally suited for clinics and […]
Sequana Medical lands IDE approval for abdominal pump trial
Sequana Medical said it has received investigational device exemption approval from the FDA to conduct a pivotal study of its Alfapump device for patients with recurrent or refractory ascites due to liver cirrhosis. Alfapump is a fully implantable pump designed to continuously remove excess abdominal fluid in patients with liver disease. Zurich-based Sequana has applied to […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
FDA panel recommends stiffer regulation of some surgical staplers
An FDA panel has recommended that surgical staplers for internal use be reclassified to a more highly regulated status. The General and Plastic Surgery Devices Panel met last week following a March alert the agency issued about internal-use surgical staplers. The devices have seen an uptick in concern over the past few months, with the FDA […]
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