Tuesday, April 9, 2019. See the November 14 Federal Register notice (83 Fed. FDA clearances, CE mark approvals… Departments - Regulatory. This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. This brand new laser was developed by Erchonia and earned multiple FDA clearances in 2018. But a closer look at the figures shows a slightly unexpected finding. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Mantle Cell Lymphoma 1.2. FRANKLIN, Mass., Sept. 5, 2019 /PRNewswire/ — Arthrosurface®, Inc., a global leader in joint preservation technology, recently received 501K clearance from the FDA for its BOSS ™ Toe Fixation System. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user’s smartphone. Enhanced FDA Calendar. The company has created the world’s largest crowdsourced platform for genetic research, with 80% of its customers electing to participate. VG Acquisition Corp. (VGAC), a special purpose acquisition company (SPAC) sponsored by Virgin Group, agreed to merge with 23andMe. FDA clearances, CE mark approvals… Medtronic, Intuitive Surgical, CardioComm Solutions, Cook Medical, Zimmer Biomet, Vertos Medical , Sensus Healthcare, Altus Partners, Robocath approvals. QIAstat-Dx is being launched with a respiratory panel designed to detect more than 20 pathogens—the first in a pipeline of planned assays for the syndromic testing system in the U.S., with plans to launch a gastrointestinal panel later in 2019. by Keri Forsythe-Stephens | Sep 6, 2019 | Clearances. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. US FDA clearances. New! Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma . 2.1 Recommended Dosage . 2.2 Recommended Dosage for Hepatic Impairment . Nvision Biomedical Technologies’ Vector Hammertoe Correction System bio-implant received FDA approval for use in the U.S. It’s the first foot and ankle implant made from the biocompatible PEEK-Optima HA Enhanced, a polymer from Invibio Biomaterial Solutions. Medtronic, Intuitive Surgical, CardioComm Solutions, Cook Medical, Zimmer Biomet, Vertos Medical , Sensus Healthcare, Altus Partners, Robocath approvals. Industry has submitted, on a confidential basis, information to FDA regarding the current food-contact uses for those four ortho-phthalates. Medtronic received 510(k) clearance of the Accurian RF ablation platform, which conducts radio frequency (RF) ablation of nerve tissues. Depuis son instauration en 1986, le Fonds de Développement Agricole (FDA) s’est donné l’objectif de promouvoir l’investissement privé dans le secteur agricole et de l’orienter, à travers des subventions et primes ciblées, vers des activités permettant une meilleure exploitation du potentiel agricole national. With the possibility of two FDA clearances in 2019 for their first planned medical devices, the company could have a breakout year if they execute and move from unknown to mainstream. "Clearance of the COVID-19 IND by the FDA speaks to the versatility of CRV431, a novel orally active cyclophilin inhibitor," commented Dr. Robert Foster, Hepion's CEO. 2 DOSAGE AND ADMINISTRATION . The main reason was the pricing and additional billing for closing/answering FDA queries. Now he is ready to integrate the FX635 into the majority of his non-invasive back and joint pain treatment protocols. MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that the FDA … The FDA’s attempts to liberalise the medical device approval processes seem to have been stymied somewhat by the US governmental shutdown in early 2019. US FDA clearances Departments - Regulatory. Since Class II devices are governed by the 510(k) clearance program in the US and these represent approximately 80% of the work-load from the FDA; we focus on 510(k)s in this analysis to get a pulse on the industry.