InVivo Therapeutics (NSDQ:NVIV) said today that it won FDA approval to shift a pilot trial of its spinal scaffold to a pivotal probable benefit study. Cambridge, Mass.-based InVivo said it expects the FDA to OK its Inspire study, designed to enroll 20 patients with spinal cord injuries, after it submits 6-month data during the 2nd quarter […]
Food & Drug Administration (FDA)
FDA releases FY2016 planned guidance docs
The FDA’s Center for Devices and Radiological Health this week released a list of guidance documents it intends to publish for the next fiscal year. The federal watchdog released 3 different lists of documents, including an A-list of 21 items it said it “fully intends to publish,” a B-list of 13 items the agency plans […]
FDA clears FujiFilm reprocessing label for ’superbug’-susceptible duodenoscopes
The FDA last week said it cleared Fujifilm Holdings‘ (TSE:4901) revised manual reprocessing instructions for its ED-530XT duodenoscope, replacing reprocessing instructions included on the original device label. Duodenoscopes are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs […]
FDA clears Biotronik’s full-body MRI-safe Iperia ICDs
Biotronik said last week it won FDA premarket approval for its Iperia family of magnetic resonance imaging-compatible implantable cardioverter defibrillators. The approval includes Biotronik’s Iperia DR-T DF-1 and DF4 configurations, the Iperia DX and Iperia ProMRI DX, the company said. “Our goal is to integrate ProMRI technology across our entire line of implantable systems, and […]
CytoSorbents scraps EAP path, pursues IDE and PMA for CytoSorb
CytoSorbents (OTC:CTSO) said today it’s dropping its pursuit of the FDA’s fast-track Expedited Access Pathway for its CytoSorb for treating sepsis. The decision came after meeting with the FDA’sCenter for Devices and Radiological Health and Center for Drug Evaluation and Research in which the company came to the conclusion that “there would be no significant time […]
FDA grants PMA nod to Medtronic for Real-Time Revel insulin mgmt system
The FDA this month granted premarket approval to Medtronic (NYSE:MDT) for its Paradigm Real-time Revel system designed to monitor glucose levels and manage insulin. Medtronic did not release any information on its plans to launch the device in the U.S. post-approval. The system is composed of both a Paradigm Real-time Revel insulin pump, Enlite glucose sensor […]
Biotronik wins 2 FDA clearances: Iperia MRI-safe ICD and Astron peripheral stent
Biotronik said today it won FDA premarket approval for its latest family of MRI compatible implantable cardioverter defibrillators and won another premarket approval for its Astron peripheral self-expanding stent system. The company’s ProMRI ICD portfolio approval includes the DF-1 and DF4 configured Iperia DR-T, the Iperia Dx hybrid ICD and the Inventra ProMRI Dx which […]
LabStyle’s Dario glucose monitor wins FDA 510(k)
Diabetes focused mobile-health developer LabStyle Innovations said today it won FDA 510(k) clearance for its Dario blood glucose monitoring system, including its blood test strips and the Dario app for Apple (NSDQ:AAPL) iOS devices. The system is designed to operate around a smartphone and a small glucose meter that communicates with the phone through the audio jack, the […]
FDA denies Materialise’s 510(k) bid for knee guide
Belgium-based additive manufacturer and 3D printing company Materialise (NSDQ:MTLS) said the FDA sent it a “not substantially equivalent” letter for its X-ray knee guide system, dooming its bid for 510(k) clearance from the federal safety watchdog. The Materialise system is designed to help align total knee replacement components without MRI or CT scans, the company said. […]
Report: FDA, medtech in bed on 21st Century Cures Act
The FDA and the medical device industry reportedly collaborated on drafting the 21st Century Cures Act before its passage in the U.S. House last summer, drawing criticism from consumer watchdogs and FDA experts. The 21st Century Cures Act, as approved on a 344-77 House vote in July, would speed new medical devices and drugs to the market […]
Torax wins FDA nod for Fenix incontinence treatment system
Torax Medical said the FDA granted premarket approval for its Fenix continence restoration system designed to treat fecal incontinence in patients who are not candidates for, or have failed with other options to treat the issue. The Fenix system is made up of a series of magnetic titanium beads that are implanted in the anal sphincter […]