Advanced Bionics has obtained the US Food and Drug Administration (FDA) approval for its new Naída CI Q70 (Naída CI) sound processor which is now commercially available in the US. Advanced Bionics in collaboration with ...
Tags: Advanced Bionics, Sound Processor
Fresenius Kabi USA has announced the availability of Levofloxacin in 5% dextrose injection in freeflex containers. Freeflex is a PVC-free, plasticizer-free, non-DEHP container, which is designed for easy handling and infusing the ...
Tags: Fresenius Kabi, Freeflex Container
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
Medical technology company Lombard Medical Technologies successfully treated the first US patients with Aorfix, its flexible stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs). Meriter Hospital vascular surgeon ...
Tags: Aortic Stent Graft
The US Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel, produced by Galderma Laboratories, for the topical treatment of the facial erythema (redness) of Rosacea in adults with 18 years or above. With a 12 ...
Tags: Facial Redness, Treatment
Ceptaris Therapeutics has obtained FDA marketing approval for Valchlor (mechlorethamine) gel to topically treat stage IA and IB mycosis fungoides-type cutaneous T-Cell lymphoma (CTCL) patients who were exposed to skin-directed therapy ...
Tags: Valchlor Gel, Ceptaris
Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes. The new ...
Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath. The IntellaTip MiFi XP is a high resolution catheter that ...
Tags: Cardiac Devices, Drug
PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its ...
Tags: PFM Medical, Medicine
Second Sight Medical Products has secured Medicare coverage for its Argus II retinal prosthesis system (Argus II) designed to treat the patients affected with blindness from the untreatable orphan disease retinitis pigmentosa in both the US ...
Tags: Government Funding, Medicine
Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg. Bioequivalence study results ...
Tags: FDA Approval, drug application
CoAlign Innovations, a US-based medical device company, has received the US Food and Drug Administration (FDA) approval for its AccuLIF XL lateral expandable interbody fusion devices. The new AccuLIF interbody system utilizes low-profile ...
Molecular diagnostics company Epigenomics has entered into a €5m convertible bond financing agreement with YA Global Master SPV Ltd. Pursuant to the terms of the agreement, YA Global Master SPV will purchase convertible notes with a ...
Tags: Epigenomics, Molecular diagnostics
Medtronic has submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon designed to treat atherosclerotic lesions in the superficial femoral artery ...
Tags: Medtronic, Admiral Drug-Eluting