Medtronic (NYSE:MDT) said today that it won FDA approval for its implantable drug-delivery system designed to administer United Therapeutics‘ (NSDQ:UTHR) pulmonary arterial hypertension drug, Remodulin. United Therapeutics is slated to take the lead on commercial promotion of the drug-device system, with support from Medtronic. The system includes Medtronic’s SynchroMed II implantable pump and a new intravascular […]
Medtech stories we missed this week: July 27, 2018
From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press releasethat it has received FDA clearance for its wireless LP1100 Life Signal […]
FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set […]
Medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition […]
FDA launches medical device innovation challenge to combat opioid crisis
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go […]
Medtech stories we missed this week: May 25, 2018
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
Reva touts first implant of bioresorbable scaffold in Turkey
Reva Medical (ASX:RVA) said today that the company launched its Fantom bioresorbable scaffold in Turkey. There are nearly 100 hospitals performing cardiac catheterizations in Istanbul, according to Reva. The San Diego, Calif.-based company highlighted Turkey as an important market for bioresorbable technologies, noting that it has a commercial distribution deal in the country with Kardionet Healthcare and […]
Intersect ENT beats The Street with Q1 sales, earnings
Shares in Intersect ENT (NSDQ:XENT) held steady today after the medical device maker topped expectations on Wall Street with its first-quarter results. The Menlo Park, Calif.-based company posted a net loss of -$6.1 million, or -21¢ per share, on sales of $24.7 million for the 3 months ended March 31, for bottom-line growth of 8.8% on […]
Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products
In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% following its launch to the commercial market. Vericel’s growing product adoption helped to fuel the company’s first profitable quarter, according to […]
Report: J&J’s Cerenovus to discontinue Codman liver cancer pump
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus is discontinuing production of its Codman pumps designed to deliver targeted chemotherapy to the liver for patients with liver cancer, according to a New York Times report. The devices are designed to be implanted in the abdomen to deliver chemotherapy directly to the liver to treat cancer that has spread […]
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