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 […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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 […]
Stryker slips on Sage Products recall
Stryker (NYSE:SYK) shares slipped today after the medical device company said it’s recalling some of the products sold by subsidiary Sage Products and narrowed its outlook for the rest of the year. Kalamazoo, Mich.-based Stryker paid $2.7 billion in April 2016 for Sage and its line of products designed to prevent so-called “never events.” But […]
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 […]
Medtronic wins CE Mark for MRI-safe Attain Stability quad CRT leads
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers. The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The […]
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, […]
Drug blocked by European regulators improves quality of life for MS patients
A study by researchers at the Queen Mary University of London has found that a drug blocked by European regulators can improve the quality of life for people with multiple sclerosis. The team of researchers reached this conclusion after uncovering previously unpublished clinical trial data from the European Medicines Agency. The European Commission is currently considering whether […]