Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Food & Drug Administration (FDA)
In2Bones wins FDA nod for 2 foot repair systems
French orthopedic surgical device developer In2Bones said today that its US subsidiary received FDA clearance for its 5MS Fracture repair and CoLag locking compression screw systems. The company’s 5MS fracture repair system is a plate and screw system designed to treat fractures and deformities of the 5th metatarsal bone and features an array of anatomically […]
Optovue wins FDA nod for optical epithelial thickness mapping system
Ophthalmological-focused developer Optovue said today it won FDA clearance for its epithelial thickness mapping software designed for quantitative measurements of the epithelial and stromal layers of the cornea. The Fremont, Calif.-based company touted it as the 1st and only FDA-cleared product which provides corneal epithelia and stromal measurements meant to aid in diagnosis of ocular health […]
Aum Cardiovascular wins FDA clearance for Cadence heart device
Aum Cardiovascular said today that it won 510(k) clearance from the FDA for its Cadence device, which is designed to detect heart murmurs. Cadence works by applying an algorithm to the acoustic signature of heart murmurs in the primary care setting, allowing physicians to diagnose the condition without resorting to expensive CT, MRI or ultrasound […]
Mauna Kea wins FDA nod for CelioFlex Cellvizio miniprobes
Mauna Kea (ENT:MKEA) said today it won FDA 510(k) clearance for its CelioFlex UHD confocal miniprobes designed for use with its Cellvizio device in robotic-assisted surgery. The CelioFlex UHD probes are designed to provide visualization of body cavities, organs and canals during endoscopic, laparoscopic and robotic-assisted procedures, the Paris-based company said. “This new FDA clearance is […]
FDA approves 4-year intrauterine device
Allergan (NYSE:AGN) and women’s health nonprofit Medicines360 said today that the FDA approved a supplemental new drug application to extend the duration of use for Liletta, a levonorgestrel-releasing intrauterine device, for up to four years. The hormone-releasing device was first approved in February 2015 and it won additional approval in January last year for a single-handed inserter. Get […]
FDA approves Jazz Pharmaceutical’s liposomal AML chemotherapy
Jazz Pharmaceuticals (NSDQ:JAZZ) said today that the FDA approved its Vyxeos injectable liposome for the treatment of adults with two types of acute myeloid leukemia. Vyxeos is the first product designed with the Dublin-based company’s CombiPlex technology, delivering a fixed-ratio of daunorubicin and cytarabine to a patient’s bone marrow. Get the full story at our sister […]
Teva wins FDA nod for Qvar RediHaler device
Teva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved its Qvar RediHaler breath-actuated inhaler for the maintenance treatment of asthma in patients ages 4 and older. The device, which is not indicated for acute bronchospasm, is slated to become commercially available during the first quarter of 2018. Get the full story at our sister site, Drug […]
GE Healthcare wins FDA 510(k) for Signa Premier MRI
GE Healthcare (NYSE:GE) said today it won FDA 510(k) clearance for its Signa Premier wide bore 3.0 Tesla magnetic resonance imaging system. The company said the Signa Premier was the result of a 4-year collaboration with the National Football League and research institutions worldwide and integrated technology to aid in the detection of biomarkers for the potential […]
FDA updates on Getinge/Datascope IABP recall, labels as Class I
The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use […]
7 medtech stories we missed this week: August 4, 2017
From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope […]