Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure. In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat […]
Axonics wins FDA nod for MR-safe neurostim device in trial
Axonics Modulation Technologies (NSDQ:AXNX) said today that the FDA approved the use of full-body MRI for clinical trial participants implanted with the company’s sacral neuromodulation device. The Irvine, Calif.-based company submitted a supplement to the FDA regarding the use of full-body MRIs in its Artisan-SNM 129-patient pivotal trial. The FDA, which is evaluating Axonics’ device via […]
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 […]
ACell to pay $15m to settle secret recall charges
ACell last week pleaded guilty to a charge that it failed to report a recall of its MicroMatrix wound dressing and settled charges that it violated the False Claims Act, agreeing to pay $15 million to put the matter to rest, the U.S. Justice Dept. said. Columbia, Md.-based ACell also agreed to abide by a […]
Artificial intelligence and medical devices: Why you need to care
Artificial intelligence presents a whole host of regulatory challenges when it comes to medical devices. Regulatory consultant Mike Drues says he has had clients forced to dumb down their AI technology, with U.S. FDA requiring they lock the algorithm. Drues sees locking the machine learning algorithm is a Band-Aid solution — not a longterm fix. […]
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 […]
Nuvectra seeks another FDA nod for spinal cord stimulation system
Nuvectra said yesterday that it filed for expanded FDA approval of its Algovita spinal cord stimulation device. The Plano, Texas-based company asked the federal safety watchdog for full-body MR-conditional approval for the Algovita SCS. The device first received FDA premarket approval in 2015. “We believe full-body MR conditional approval in the U.S., in addition to Algovita’s […]
Ivenix wins 510(k) clearance for infusion system
Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. Get the full story at our sister site, Drug Delivery Business News.
Masimo wins FDA clearance for neonatal O3 regional oximetry indication
Masimo (NSDQ:MASI) said today that it won FDA clearance for use of its O3 Regional Oximetry system with neonatal and infant patients. The Irvine, Calif.-based company’s technology uses near-infrared spectroscopy to assess the regional hemoglobin oxygen saturation of blood on both sides of the brain. The O3 sensors are now available in sizes to fit adult, […]
FDA permits marketing of pain relief device for kids with IBS
The FDA reported last week that it permitted marketing of the first medical device to reduce functional abdominal pain in patients ages 11-18 with irritable bowel syndrome. The U.S. regulatory body said the IB-Stim device, made by Innovative Health Solutions, could be used by this patient population when combined with other IBS therapies. The device […]
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 […]
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