Hancock Jaffe Laboratories (NSDQ:HJLI) said today that Colombia’s Ethics Committee at Fundación Santa Fe de Bogotá approved a first-in-human trial of its VenoValve bioprosthetic valve. The Irvine, Calif.-based company’s VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA approves Wisconsin plant for NorthStar Medical’s RadioGenix imaging agent
NorthStar Medical Radioisotopes said today it won FDA approval for its Beloit, Wisc.-based manufacturing facility to begin producing its RadioGenix system and associated materials. The approval was made through a Prior Approval Supplement to the company’s recently approved RadioGenix system new drug application 202158, NorthStar said, and serves as the first step in expanding its […]
Smith & Nephew warns on first-gen Journey BCS knee revision rate
Smith & Nephew (NYSE:SNN) recently released an urgent field safety notice warning of issues with components in the first generation of its Journey BCS knee system that can lead to a higher rate of revisions than expected. The notice, originally sent in June, warned that post-market surveillance data showed that patients implanted with the first gen […]
Following FDA nod, Ferring plans launch for needle-free drug-delivery system
Ferring Pharmaceuticals said last week that the FDA approved its injectable somatropin product for four additional pediatric indications: idiopathic short stature, short stature associated with Turner syndrome, short stature born small for gestational age with no catch-up growth by 2 – 4 years and growth failure in short stature homeobox-containing gene deficiency. In connection with the […]
Roche wins CE Mark for Accu-Chek Solo insulin micropump
Roche (OTC:RHHBY) said today that it won CE Mark clearance for its Accu-Chek Solo insulin micropump system. The company plans to launch a pilot commercialization phase for its device in the coming weeks in Austria, Poland, Switzerland and the U.K. Get the full story at our sister site, Drug Delivery Business News.
FDA announces halt to U.S. Essure sales by Bayer
The FDA said today that Bayer (ETR:BAYN) will no longer sell or distribute its Essure permanent birth control device in the U.S., effective Dec. 31. FDA Commissioner Scott Gottlieb said the action follows a “series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use,” according to an FDA […]
Companion Medical wins CE Mark for InPen insulin pen
Companion Medical said yesterday that it won CE Mark approval in the European Union for its InPen smart insulin pen and associated diabetes management smartphone application. The company’s InPen system consists of a smart insulin injection pen that connects with an integrated diabetes management app. Read the whole story on our sister site, Drug Delivery Business […]
FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery. The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set to […]
Syneron Candela wins FDA nod for Vbeam Prima cosmetic laser
Syneron Candela said today it won FDA clearance for a next-gen version of its Vbeam, the Vbeam Prima cosmetic laser designed to treat skin conditions. The newly cleared device is intended for use in treating skin conditions including rosacea, port wine stains, acne, facial, leg and spider veins, scars, benign pigmented lesions and wrinkles, warts, […]
FDA issues warning for Claris manufacturing site bought by Baxter
The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month. Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter. Get the full story at […]
Vallum wins FDA nod for nano-textured PEEKplus spinal implant
Vallum Corp said today it won FDA 510(k) clearance for its PEEKplus nanotextured spinal interbody fusion device, touting it as the first nanotextured PEEK interbody device to win an FDA nod. The Nashua, N.H.-based company’s PEEKplus nanotextured surface features nano-scale concavities of between 20 and 50 nanometers created by the impact of argon atoms across […]