The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising by more than 33%, with the fee for one popular protocol jumping more than 125%. All but one of the user fees for fiscal 2018, which begins Oct. 1, are going […]
Food & Drug Administration (FDA)
Acorda shares plunge -30% after FDA refuses to review NDA
Shares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete. The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for inspection […]
Medizone to pursue de novo pathway for AsepticSure disinfection system
Medizone said last week it will pursue de novo clearance for its AsepticSure disinfection system after speaking with the FDA about its 513(g) submission. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device […]
Sorrento seeks FDA nod for lidocaine patch
Sorrento Therapeutics (NSDQ:SRNE) said today that its subsidiary Scilex Pharmaceuticals resubmitted the new drug application for its lidocaine patch, ZTlido, to the FDA. The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia. Get the full story at our sister site, Drug Delivery Business News.
NxStage Medical wins expanded FDA nod for System One home hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won expanded FDA clearance for its System One home hemodialysis system, clearing it for use without a care partner during waking hours. The system won initial clearance in 2005 and added clearance for home nocturnal hemodialysis in 2014, the Lawrence, Mass.-based company said, but has always required a care […]
FDA clears Second Sight IDE trial of next-gen Orion cortical visual prosthesis
Second Sight Medical (NSDQ:EYES) said today it won FDA investigational device exemption to initiate a feasibility clinical study of its Orion cortical visual prosthesis system. The conditional approval gives the Sylmar, Calif.-based company clearance to enroll up to 5 patients at 2 US sites, but requires that the company conduct additional device testing and “address outstanding […]
FDA intervenes after stem cell center offers unproven treatment to cancer patients
The FDA is cracking down on stem cell clinics that administer unproven and potentially dangerous treatments to patients, citing a California-based clinic that the regulatory watchdog said was treating cancer patients with the smallpox vaccine. The only reliable treatment is this stem cell treatment therapy, it´s the only one that has been proven yet to […]
Bard lands new indication for its drug-coated balloon
C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S. The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat […]
Tandem Diabetes wins FDA nod for insulin pump with Dexcom’s CGM
Tandem Diabetes Care (NSDQ:TNDM) said today that the FDA approved its t:slim X2 insulin pump with Dexcom‘s (NSDQ:DXCM) G5 mobile continuous glucose monitor. The regulatory win makes the device the first sensor-augmented insulin pump cleared to let users make treatment decisions without pricking their finger, the company touted. Get the full story at our sister site, Drug […]
Abbott wins FDA nod for HeartMate 3 pump
Abbott (NYSE:ABT) said today that the FDA approved its HeartMate 3 implantable pump for heart failure patients awaiting a transplant. The approval is the latest for the HeartMate line of left ventricular assist devices first developed by Thoratec, which was later acquired by St. Jude Medical before a $25 billion merger brought it to Abbott earlier this […]
FDA clears Nordisk’s Victoza as only Type II diabetes drug to cut cardio risks
The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke. The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the risk […]