AdvaMed last month sent a letter to the FDA criticizing a new rule which changes the group’s definition of “intended uses”, saying it could negatively impact scientific communication, device development and make manufacturer’s liable for any off-label use by merely knowing it exists. The letter was released last week by the FDA, and is in […]
Food & Drug Administration (FDA)
FDA clears updated labeling, design for FujiFilm ED-530XT duodenoscopes
Fujifilm Medical (TSE:4901) today issued a select voluntary recall for its model ED-530XT duodenoscopes after the FDA cleared an update to the design and labeling of the device, intending to supply customers with new forceps elevator mechanism from Platform Lift, O-ring seals, distal end caps and updated operations manuals. The company said it won FDA clearance […]
DarioHealth wins FDA nod for Android diabetes app
DarioHealth (OTCQB:DRIO) said yesterday it won FDA 510(k) approval for its Dario diabetes management application on certain Google (NSDQ:GOOG) Android devices. The approval expands the Israel-based company’s availability from exclusively Apple (NSDQ:AAPL) iOS products, which it has had clearance on since winning FDA clearance for its Dario blood glucose monitoring system in December 2015. DarioHealth said the […]
Trump pushes ‘America First’ policy with pharmaceutical packaging industry
Donald Trump yesterday revealed an initiative to bring jobs and investment into the U.S. drug packaging industry, spearheaded by Corning Inc. (NYSE:GLW), Merck (NYSE:MRK) and Pfizer (NYSE:PFE). At the ‘Made In America’ event, Trump announced that the companies are making a $500 million investment to create 1,000 jobs at manufacturing facilities in New York, New Jersey and an unnamed site in […]
FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations. The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use […]
7 medtech stories we missed this week: July 21, 2017
From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation […]
TSO3 files FDA app seeking duodenoscope indication for Sterizone VP4 sterilizer
TSO3 said today it filed a 510(k) application with the FDA as it seeks to clear its Sterizone VP4 sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography procedures. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of […]
Braeburn, Camurus seek FDA nod for buprenorphine depot
Camurus AB (STO:CAMX) and Braeburn Pharmaceuticals said today that the companies submitted a new drug application to the FDA for its weekly and monthly buprenorphine depots to treat opioid use disorder. Braeburn also reported that it applied for priority review of its application, which could potentially shorten the company’s path to the market. Get the full story at […]
Lawsuit stalls approval of Merck’s insulin injection
Merck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection. The biologic basal insulin met regulatory standards, the company said, but a patent infringement lawsuit initiated by competitor Sanofi (NYSE:SNY) in September of last year invoked an automatic delay for the drug-device combination product’s final approval. Get the full story at […]
FDA sends warning letter to phototherapy dev Nat’l Biologics Corp
The FDA today released a warning letter it sent to phototherapy device maker National Biological Corp. this month over issues it found during an inspection of the company’s Beachwood, Ohio-based facilities. The federal watchdog identified 8 total violations, and requested that the company take immediate action to correct the violations. Included in the violations were […]
Biotronik wins FDA nod for atrial lead-less Intica ICD line
Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US. The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity […]