Avinger (NSDQ:AVGR) said today it won expanded indications from the FDA for its Pantheris Lumivascular atherectomy system, now cleared for diagnostic imaging as well as treatment for peripheral artery disease. The Redwood City, Calif.-based company touted the win, saying its Pantheris is the 1st and only image-guided atherectomy device to receive clearances as both a diagnostic […]
Food & Drug Administration (FDA)
FDA awards product development grants for rare diseases
The FDA said yesterday that it awarded 21 clinical trial research grants totaling more than $23 million over the next 4 years to stimulate product development for patients with rare diseases. The Orphan Products Clinical Trials Grants Program has awarded more than $370 million to fund more than 590 clinical studies since its creation in […]
Vascular Solutions bids for FDA nod for RePlas freeze-dried plasma
Vascular Solutions (NSDQ:VASC) said today that it filed an investigational new drug application with the FDA for the RePlas freeze-dried plasma product it’s developing with the U.S. Army Medical Material Development Activity. RePlas is an easily transported, freeze-dried alternative to fresh frozen plasma, which requires freezing and a lengthy thawing process before it’s ready to use. According to the development […]
Report finds delays, loopholes in FDA’s adverse event reporting
The FDA allows medical device companies to file adverse event reports well after the fact and to conceal most of the details from public view, according to agency records obtained by the Minneapolis Star Tribune under the Freedom of Information Act. The newspaper’s analysis showed that the FDA allowed medical device companies to file “retrospective summary […]
FDA approves Genentech’s Lucentis pre-filled ranibizumab syringe
Genentech, a member of the Roche group (PINK:RHHBY), said today that it won FDA clearance for its Lucentis (ranibizumab injection) pre-filled syringes. The anti-VEGF medicine is FDA-approved to treat wet age-related macular degeneration and macular edema after retinal vein occlusion. The pre-filled syringe enables physicians to eliminate steps in preparation and administration process, the company […]
Philips wins FDA nod for Lumify S4-1 transducer
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for an S4-1 cardiac transducer for its Lumify smart-diagnostic ultrasound device. The newly cleared S4-1 transducer is pocket-sized and lightweight, Philips touted, designed to improve sensitivity and provide high-resolution 2D images. “Our vision for smart-device ultrasounds is focused on putting high-quality devices in the hands […]
Medtronic wins MRI-safe nod from FDA for full suite of cardiac rhythm management devices
Medtronic (NYSE:MDT) said today that it won FDA approval for its full suite of MRI-safe cardiac rhythm and heart failure devices and leads for 3- and 1.5-Tesla scans, touting the approval as the 1st of its kind in the U.S. The regulatory win allows current patients with Fridley, Minn.-based Medtronic’s SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators and […]
FDA inks deal with CluePoints to use data to sniff out sloppy or fraudulent clinical trials
The FDA said today it inked a cooperative research and development agreement with statistical monitoring company CluePoints to identify clinical trial sites that don’t meet the agency’s standards. The CluePoints platform is designed to use “statistical algorithms to determine the quality, accuracy and integrity of clinical trial data during and after studies are conducted,” the company said. […]
FDA, MDIC press their ‘Case for Quality’
The Case for Quality, a collaborative effort between the FDA and the medical device industry, released its 1st report today, focused on the safety and efficacy of knee implants and cardioverter defibrillators. The Case for Quality looks to assess the feasibility and effectiveness of using standardized medical device performance data and analytics in an effort to help […]
BioStable Science & Engineering seeks FDA de novo indication for Haart 300 annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said today it completed a de novo application to the FDA as it seeks Class II designation for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company said its Haart 300 is an internal aortic annuloplasty ring designed to replicate the anatomy of the aortic valve and […]
St. Jude wins FDA nod, launches PressureWire X FFR system
St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its PressureWire X guidewire fractional flow reserve measurement system and launched the device in the U.S. The PressureWire guidewire system is designed to measure arterial blood pressure by calculating fractional flow reserve associated with stenosis in patients with coronary artery disease. The next-gen version of the device […]