Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA. The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days. Get the […]
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 […]
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.
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 […]
Bovie Medical seeks new FDA indications for J-Plasma, Renuvion tech
Bovie Medical (NYSE:BVX) said today it submitted a 510(k) premarket notification to the FDA seeking expanded clearance for its J-Plasma and Renuvion technology. The Clearwater, Fla.-based company, which is looking to rebrand under the new moniker Apyx Medical Corporation beginning next year, said it is looking to clear the system for use in dermal resurfacing procedures. […]
CathWorks wins FDA 510(k) for FFRangio
Non-invasive fractional flow reserve tech developer CathWorks said yesterday that it won FDA 510(k) clearance for its FFRangio non-invasive fractional flow reserve analysis technology. The Israel-based company said that approval came based off of results from the FAST-FFR blinded comparative study study which showed that its FFRangio system was accurate when compared to invasive FFR. “The FDA […]
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