SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. Get the full story at our sister site, Drug Delivery Business News.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Sunovion seeks FDA nod for COPD treatment – again
Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application. Get the full story at our sister […]
CMS spikes Medicare Advantage data release at the last minute
Medicare Advantage, privately run health plans paid for by Medicare, have covered an increasing number of seniors and disabled people in recent years. More than 1/3 of the 58 million Medicare beneficiaries opt for these non-traditional plans. The government has been collecting data about the care delivered to these enrollees since 2012. Last year, it […]
SciBase wins FDA PMA nod for Nevisense malignant melanoma detector
Medical device company SciBase said today it won FDA pre-market approval for its Nevisense device designed for the early detection of malignant melanoma. The Stockholm-based company’s device is indicated for use on cutaneous lesions with 1 or more clinical or historical characteristics of melanoma, for obtaining additional information when considering a biopsy, the company said. […]
LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients
LivaNova (NSDQ:LIVN) said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications. The London-based company touted that with the clearance, its VNS Therapy system is the only FDA-approved device for drug-resistant epilepsy in the pediatric […]
Spineology wins FDA nod for Rampart One lumbar interbody fusion system
Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system. The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated […]
K2M wins FDA nod for Capri 3D-printed corpectomy cage
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for its Capri small 3D static corpectomy cage system, touing it as the 1st-to-market 3D-printed, FDA-cleared device of its kind. The newly cleared device is designed for stabilizing the thoracolumbar spine during vertebral body resections as a result of trauma or tumors, the Leesburg, Va.-based company said. […]
Medtronic wins CE Mark for SureTune3 deep-brain stimulation software
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its SureTune3 deep-brain stimulation software, which is designed to map lead locations and indicate the level of stimulation. The Fridley, Minn.-based Medtronic said its DBS devices are approved in the E.U. for treating Parkinson’s disease, dystonia, essential tremor, obsessive-compulsive disorder and […]
Philips wins FDA 510(k) for IntelliSpace Portal 9 informatics platform
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its IntelliSpace Portal 9.0 clinical informatics platform and associated applications for radiology. The newly cleared platform now includes additional applications for longitudinal brain imaging and multi-modality tumor tracking, as well as lung nodule assessment, the company said. “Analytics applications optimized for clinical decision support and […]
FDA clears Custom Ultrasonics to resume manufacturing System 83 endoscope washer-disinfector
Custom Ultrasonics said yesterday that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and disinfector for use with non-duodenoscope endoscopes. The Philadelphia-based company said that it was required to perform independent validation testing for its System 83 Plus water filtration […]
Theraclion partner UVA wins FDA nod for combined HIFU, immunotherapy breast cancer trial
Theraclion said yesterday its academic development partner, the University of Virginia, won an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer. The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French […]