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 […]
Food & Drug Administration (FDA)
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 […]
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, […]
FDA approves Malin’s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug. The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device. “This is the 1st integrated, over-the-wire device designed for peripheral […]
BioVentrix wins FDA IDE nod, launches Revivent TC trial
BioVentrix said today it received FDA investigational device exemption approval and launched a safety and efficacy trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients suffering from ischemic cardiomyopathy. The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small […]
Trump signs FDA user fee bill into law
President Donald Trump last week signed a bill to re-up the agreement between the FDA and the medical device and pharmaceutical industries, putting medical device companies in line for a collective $1 billion in user fees. Companies pay user fees to help cover the cost of the safety watchdog’s reviews of their products. The bill […]
Becton Dickinson blood tubes under investigation in FDA probe of faulty lead tests
(Reuters) – Blood collection tubes made by Becton Dickinson & Co. (NYSE:BDX) that were used in conjunction with Magellan Diagnostics‘ lead-testing devices are still being investigated as a potential cause of inaccurate lead test results. The FDA in May had warned that Magellan’s LeadCare test systems performed on blood samples might provide inaccurate results. Prior to that, […]
Globus Medical jumps on FDA nod for Excelsius GPS robot-assisted surgery platform
Globus Medical (NYSE:GMED) said today that it won 510(k) clearance from the FDA for its long-awaited Excelsius robot-assisted surgery platform, which is designed to integrate intra-operative CT and fluoroscopic imaging technologies. Audubon, Pa.-based Globus said the clearance covers minimally invasive and open orthopedic and neurosurgical surgeries, including screw placement in spinal and orthopedic procedures. The system won CE […]
Camber Spine wins FDA nod for Spira interbody fusion device
Camber Spine Technologies said today it won FDA 510(k) clearance from the FDA for its Spira open matrix anterior lumbar interbody fusion device. The Wayne, Penn.-based company said the Spira device consists of spiral support arches designed to increase fusion rates and stabilization. The company said the spiral support arches also decrease subsidence by load […]
Stryker wins FDA nod for Serrato pedicle screws
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its Serrato pedicle screw, designed for use in the non-cervical spine as part of its Xia 3 spinal system. The Serrato pedicle screws feature enhanced serrated cutting flutes, a dual-thread pattern with increased leads for rapid insertion and a buttress thread locking mechanism designed to reduce […]