Merit Medical (NSDQ:MMSI) said yesterday that its Embosphere device won expanded de novo clearance from the to treat benign prostatic hyperplasia. The federal safety watchdog’s clearance means Embosphere can be used in prostatic artery embolization procedures to treat BPH. “Merit’s Embosphere is the first embolic agent to receive FDA 513(f)(2) classification for prostatic artery embolization, providing a non-surgical […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Bard wins FDA approval for LifeStream covered iliac stent
C.R. Bard (NYSE:BCR) said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said. […]
Sommetrics wins Health Canada nod for non-invasive sleep apnea device
San Diego-based Sommetrics said yesterday it won Health Canada approval for its AerSleep system designed to apply negative external pressure to maintain an open airway during sleep. The company said that the AerSleep system was cleared as a prescription device for individuals diagnosed with obstructive sleep apnea. The system features a soft collar and integrated silent […]
Insulin management software wins FDA nod
Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance. The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower […]
ClearFlow wins FDA 510(k) for FlowGlide
ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains. The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions. “ClearFlow is […]
Exactech wins Japanese nod for shoulder, knee, hip replacement systems
Exactech (NSDQ:EXAC) said today that won Japanese approval for its shoulder, knee and hip replacement systems and that the devices had been recently used in their 1st procedures in the region. The Gainesville, Fla.-based company said it won regulatory approval to introduce additional products from its 3 segments to the Japanese market, including its Optetrak Logic […]
Aethlon looks fast-track FDA nod for Hemopurifier blood filter through EAP
Aethlon Medical (NSDQ:AEMD) said today it is submitting an expedited access pathway application to the FDA seeking a breakthrough technology designation for its hemopurifier. Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250 nanometers in diameter. […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]
Swiss Kuros Biosciences wins CE Mark for NeuroSeal dural sealant
Swiss tissue repair and regenerative med focused Kuros Biosciences said today it won CE Mark approval in the European for its Neuroseal novel dural sealant. The Neuroseal sealant is designed as an adjunct to suturing and is used to seal the dura after cranial surgery and reduce the risk of cerebrospinal fluid leakage, the company […]
pSivida seeks European regulatory nod for Durasert
pSivida (NSDQ:PSDV) is looking to market its Durasert 3-year treatment for posterior segment uveitis in the European Union. Today, the Watertown, Mass.-based company submitted a marketing authorization application to the European Medicines Agency. Earlier this month, pSivida reported that its 2nd Phase III trial, which followed patients for 3 years, met its primary endpoint of […]
Cochlear shares jump on FDA nod for Nucleus 7 sound processor
Hearing implant maker Cochlear Ltd. (ASX:COH) has seen shares rise nearly 4% after the company won FDA approval for its Nucleus 7 sound processor, according to a Motley Fool Australia report. The newly cleared N7 processor is superior to its prior N6 version, and is compatible with Apple’s iOS, while its telecoil is optimized for loops, according […]