Results RNA said this week that it voluntarily recalled its Lubrisine eye drops following an FDA inspection that found the product was not manufactured with sterile practices. The company also said that the eye drops, which are designed to lubricate dry eyes, were found to contain undeclared colloidal silver. Exposure to colloidal silver over an extended […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
New EU regulatory changes are coming: Here’s what you need to know
Despite major changes coming to the EU regulatory system in under two years, many companies are still scrambling to develop strategies for handling the MDR and IVDR implementation in the region. Last month at DeviceTalks West, Abbott regulatory affairs director Caroline Leab Byrd, R&Q regulatory affairs director Nancy Morrison and 30-year regulatory vet Artha Nafie […]
Axonics submits interim data to FDA for sacral neuromod device
Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted interim clinical data from the pivotal study of its implantable sacral neuromodulation system to the FDA. The company is evaluating its r-SNM system as a therapy for people with urinary dysfunction. Axonics’ interim analysis was submitted as a supplement to the company’s “literature-based” premarket approval application. The […]
Titan Medical eyes 2019 for U.S., EU Sport robot submissions
Titan Medical (NSDQ:TMDI) said today that it expects to file for 510(k) clearance in the U.S. and CE Mark clearance in the E.U. by the end of 2019 for its Sport robotic surgical system. The company added that based on the timing of the approvals, Titan plans to begin commercializing its single-port robotic system in […]
FDA clears Brainscope’s concussion Dx device
BrainScope said today that it won FDA clearance to include new indication language for its BrainScope One concussion assessment device. Following a multi-parameter assessment, the company’s device can determine the likelihood of the presence and severity of a concussion or mild traumatic brain injury. “This additional FDA labeling for our product, BrainScope One, recognizes the unique […]
Cardiovascular Systems wins Japanese nod for next-gen Diamondback 360 atherectomy device
Cardiovascular Systems (NSDQ:CSII) said today it won approval from Japan’s Ministry of Health, Labor and Welfare for its Diamondback 360 coronary orbital atherectomy system and its Classic Crown and ViperWire Advance coronary guidewire FlexTip. The Classic Crown includes a a 1.25mm diamond-coated crown and uses centrifugal force and differential sanding to safely modify arterial calcium, the […]
PolarityTE registers bone repair product with FDA
PolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA. The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells. Get the full story at our sister site, Drug Delivery Business News.
FDA gives Edwards’ Sapien 3 Ultra TAVR the nod
Edwards Lifesciences (NYSE:EW) can now market its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in the United States. The FDA approved the device for severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered an intermediate or greater risk, the Irvine, Calif.-based company said. For the Ultra, Edwards has added a taller […]
Acorda wins FDA nod for inhaled Parkinson’s therapy
Acorda Therapeutics (NSDQ:ACOR) said this week that the FDA approved its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s […]
FDA approves Teva’s digital COPD, asthma inhaler
Teva (NYSE:TEVA) said this week that the FDA approved its ProAir Digihaler device – a digital inhaler that uses sensors to connect to a companion mobile app for people with asthma and chronic obstructive pulmonary disease. The company’s device features built-in sensors that can measure inspiratory flow and detect when the inhaler is used. After the […]
Obalon wins FDA nod for Obalon Nav system
Obalon Therapeutics (NSDQ:OBLN) said today that it won FDA clearance for its Obalon Navigation system intended for use in placing the company’s Obalon Balloon system. The newly cleared Obalon Navigation system uses magnetic resonance imaging during placement and displays a real-time image of the balloon, the San Diego-based company said. The system is intended for use […]