C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S. The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Tandem Diabetes wins FDA nod for insulin pump with Dexcom’s CGM
Tandem Diabetes Care (NSDQ:TNDM) said today that the FDA approved its t:slim X2 insulin pump with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor. The regulatory win makes the device the first sensor-augmented insulin pump cleared to let users make treatment decisions without pricking their finger, the company touted. Get the full story at our sister site, Drug […]
Abbott wins FDA nod for HeartMate 3 pump
Abbott (NYSE:ABT) said today that the FDA approved its HeartMate 3 implantable pump for heart failure patients awaiting a transplant. The approval is the latest for the HeartMate line of left ventricular assist devices first developed by Thoratec, which was later acquired by St. Jude Medical before a $25 billion merger brought it to Abbott earlier this […]
FDA clears Nordisk’s Victoza as only Type II diabetes drug to cut cardio risks
The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke. The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the risk […]
7 medtech stories we missed this week: Aug. 25, 2017
From InspireMD’s Swiss distribution deal to CoreLink’s stackable guide wire launch, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD announces Swiss distribution deal InspireMD announced in an Aug. 25 press release that it has signed an agreement with 1a Medical to distribute the CGuard EPS […]
Abbott’s St. Jude Medical can’t escape Riata lead lawsuit
Abbott (NYSE:ABT) subsidiary St. Jude Medical can’t escape a product liability lawsuit brought over its recalled Riata defibrillator leads, a federal judge in California ruled this week. St. Jude pulled the silicone-coated Riata and Riata ST leads in 2010 after finding that some of the internal conductors had worn through their insulation, a failure that […]
NxStage Medical’s Todd Snell talks FDA, Brexit & regulatory strategy
Between the consequences of Brexit and a new commissioner at the FDA, executives across medtech are bracing for change within the global regulatory landscape. NxStage Medical‘s (NSDQ:NXTM) SVP of quality assurance, regulatory & clinical affairs, Todd Snell, spoke with MassDevice.com editor Sarah Faulkner about what he’s observing from his post at the Lawrence, Mass.-based company. Faulkner: What […]
Could this new assay reduce the need for animal tests?
American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs. Mark E. Smith, American Preclinical Services Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for […]
Ra Medical CEO Irwin aims for Feb 2018 IPO
In May, Ra Medical received a nod from the FDA for its Dabra arteriosclerosis laser, clearing it for use in the US. It was a decision the company had been waiting on for approximately 3 years, CEO Dean Irwin told MassDevice.com in an interview, and signaled a significant shift forward. “In 2014, we submitted to the FDA, […]
Titan wins FDA nod to study Parkinson’s implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA cleared the investigational new drug application for its ropinirole implant designed to treat the symptoms of Parkinson’s disease. The Phase I/II trial, which is slated to enroll 20 patients with idiopathic Parkinson’s disease, will transition patients taking oral ropinirole to Titan’s ropinirole implant for three months of treatment, […]
Arch Therapeutics CEO Dr. Norchi looks to bring advanced material tech to wound management
Arch Therapeutics (OTC:ARTH) is looking to bring advanced material technology to wound care, and in July, the company got one step closer by submitting its application to the FDA for 510(k) clearance for its 1st commercial product, a topical gel based on its AC5 wound care platform. The company’s products are designed around technology out of […]