Johnson & Johnson (NYSE:JNJ) Vision said today that the FDA approved its iDesign Refractive Studio for planning Lasik eye procedures. iDesign uses a three-second scan to perform a wavefront analysis of how light travels inside the eye and maps the topography of the cornea to customize Lasik treatments for myopia, hyperopia, mixed astigmatism and presbyopic myopia, […]
AMG Int’l wins CE Mark for Archimedes bioresorbable biliatric stent
Q3 Medical Devices’ AMG International said today it won CE Mark approval in the European Union for its Archimedes biodegradable biliary and pancreatic stent. The Winsen, Germany-based company touts the Archimedes as the only fully biodegradable biliary and pancreatic stent cleared for use in obstructed biliary or pancreatic ducts globally. “The Archimedes biodegradable stent represents […]
FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. Get the […]
Medtronic wins FDA nod for new lengths of drug-coated balloon
Medtronic (NYSE:MDT) said today that it won FDA approval for 200mm and 250mm lengths of its In.Pact Admiral drug-coated balloon. The newly-approved lengths are designed to treat patients with longer, more complex superficial femoral artery lesions, according to the medtech giant. Get the full story at our sister site, Drug Delivery Business News.
7 medtech stories we missed this week: June 15, 2018
From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]
FDA rejects Mylan’s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to […]
Wright Medical wins FDA PMA for Augment injectable bone graft
Wright Medical (NSDQ:WMGI) said today it won FDA premarket approval for its Augment injectable bone graft. The bone graft won clearance for the same indications as the Amsterdam-based company’s non-injectable Augment bone graft. The newly cleared Augment Injectable consists of both recombinant human platelet derived growth factor and a blend of Type I collagen and beta tri-calcium […]
Here’s how FDA officials think you can legally promote off-label device, drug uses
The FDA has issued final guidance clarifying what it considers permissible off-label information for devicemakers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the agency […]
Medtronic wins FDA nod for DBS clinician programmer
Medtronic (NYSE:MDT) said today it won FDA approval for its Deep Brain Stimulation clinician programmer and Activa programming application. The Fridley, Minn.-based medtech giant said that the Activa programming application, which is designed for use with Samsung Galaxy Tab S2 tablets, is intended to streamline workflows and improve clinician programming for its Activa DBS system. Medtronic said […]
OptoVue wins FDA nod for AngioAnalytics tech
Ophthalmological-focused developer Optovue said yesterday it won FDA 510(k) clearance for its AngioAnalytics optical coherence tomography angiography blood vessel measurement tech designed to aid in managing disease that cause progressive blindness. The Fremont, Calif.-based company said it also won clearance for its 3D projection artifact removal software, designed to improve OCTA image quality to allow for accurate […]
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