Saturday, December 3, 2022
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FDA

Triastek Receives FDA IND Clearance for 3D Printed Medicine for the Treatment of Ulcerative Colitis

Dr. Senping Cheng, founder and CEO of Triastek. "Delaying drug release and delivering oral dosage forms to the colon is challenging, so T21 offers a promising new option for patients by providing site-specific drug delivery and localized drug effect, mitigating potential side effects from systemic exposure. We look forward to advancing this treatment into the clinic and appreciate the FDA's support. "

SafeSource Direct Receives FDA Clearance for American-Made PPE

Justin Hollingsworth, CEO, SafeSource Direct. “While COVID-era shortages and substandard products may seem like things of the past, the risk that our nation’s healthcare providers find themselves in a similar situation remains very real. That’s why we’re offering a solution that sidesteps the supply interruptions and lack of quality control that come with dependence on foreign manufacturers.”

Evolution Optiks Limited Completes Enrollment of U.S. FDA Clinical Study of LFR-260 Phoropter

Andreas Kusay, Chairman of Evolution Optiks, adds: "The regulatory clearance of the LFR-260 to be used as a tele-operable phoropter would add a very attractive solution to a rather stagnant market and unlock a significant addressable market expansion opportunity.

CurvaFix Receives FDA Clearance for Smaller-diameter, Intramedullary Implant for Pelvic Fracture Fixation

“With this latest FDA clearance, we are able to offer surgeons CurvaFix Implant in two diameters, 7.5mm and 9.5mm, and in lengths ranging from 90mm to 180mm,” said Steve Dimmer, CurvaFix chief executive officer.

FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic)....

NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use

Evo® sEEG System epresents the Company's second FDA 510(k) cleared product. NeuroOne now provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures.

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