Devices
Recent medical device reports are linking a superbug outbreak at a foreign health facility to a duodenoscope that Olympus modified last year in an move to reduce its risk of spreading bacteria between patients, according to a article by LA Times investigative reporter Melody Petersen. Five patients treated with the
Devices
FDA has approved Alcon’s new AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens (IOL) with ActiveFocus design for uncompromised distance vision and presbyopia correction. The device is intended to give astigmatic cataract patients “quality distance vision and an increased range of vision to potentially reduce dependence on glasses,
Devices
AdvaMedDx says it is reviewing a discussion draft of the Diagnostic Accuracy and Innovation Act being circulated in the House by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO). The trade group says it has “long supported a modernized, risk-based approach to FDA oversight of all diagnostic
Devices
FDA has approved a CeloNova Biosciences PMA for its COBRA PzF NanoCoated Coronary Stent System. The device, which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to the company. The stent is designed to improve coronary luminal diameter
Drugs
Attorney James Beck (Reed Smith) says that if FDA ends its ban on truthful off-label promotion under incoming commissioner Scott Gottlieb, warnings that drug and medical device companies will face increased liability don’t ring true. Writing in an online blog post, Beck disputes assertions made in a 3/
Devices
FDA has approved a Medtronic PMA for the CoreValve Evolut PRO valve for treating severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval was based on 30-day clinical data that “showed high survival, low rates of stroke, minimal paravalvular
Drugs
The Combination Products Coalition says that while it agrees with many of the recommendations in an FDA draft guidance on comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, it believes there should be several revisions. The coalition says it
Devices
FDA says it has launched a Web site to promote advancement of infectious disease next generation sequencing (ID-NGS) technology. CDRH says that next generation sequencing may allow the diagnosis of infections without prior knowledge of disease causes. “Using ID-NGS technology, each microbial pathogen may be identified by its
Devices
FDA says it agrees with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. In an update, the agency says that at this time, most data suggest that BIA-ALCL occurs more
Drugs
Former FDA commissioner Robert Califf told a 3/14 Clinical Trials Transformation Initiative webinar that better educational efforts are needed so that everyone in the clinical trial chain understands the entire process and not only their own role during a specific trial segment. In a presentation entitled “A Viewpoint on
Devices
FDA has cleared a Trovita Health Science 510(k) for its Safe-T Feed device for administering tube feeding formulas. The company says its device is a ready-to-feed pouch offering the first fully-closed system, pre-packaged with complete enteral formulas. It is intended to simplify the tube
Devices
FDA has approved Allergan’s Juvéderm Vollure XC gel for correcting moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults aged 21 and older. Approval was based on data from a U.S pivotal clinical trial where the majority (59%) of subjects saw improvement in moderate
Devices
FDA has cleared a Teleflex 510(k) for the Twin-Pass Torque Dual Access Catheter, which is designed for procedures that “call for the delivery of two interventional guidewires from a single catheter in clinical situations where catheter delivery and torsional control are paramount,” according to the company. The device
Devices
FDA has cleared a Toshiba Medical 510(k) for the Aplio i900 ultrasound platform. “Ideally suited for contrast, fetal, pediatric, stress echo and transesophageal echocardiography imaging, the Aplio i900 delivers extreme processing power which helps healthcare providers see more in their ultrasound exams due to thinner beam slices and more
Devices
FDA has cleared a DJO Global 510(k) for its Exprt Revision Hip. “The two-tray revision system represents an 80-90% reduction in instruments compared to competitive systems,” the company says. The device features 3 degree taper geometry for axial stability, and “optimized splines providing 0.2mm of press-
Drugs
Sen. Richard Durbin (D-IL) has introduced two bills to provide steady increases for biomedical and scientific research at a number of federal research agencies. In a statement, Durbin says the bills “will allow America’s best scientists and researchers to spend less time worrying about their budgets and more
Devices
FDA has cleared a Millar, Inc. 510(k) for its Mikro-Cath Pressure Catheter for use in monitoring intracompartmental and airway pressures. This expanded 510(k) adds to the Mikro-Cath’s previous clearance for use in cardiovascular pressure monitoring. The device “provides the advantage of acquiring high-fidelity data
Devices
FDA has approved a Medtronic PMA for its Melody Transcatheter Pulmonary Valve (TPV) and its implanted use in patients whose surgical bioprosthetic pulmonary heart valves have failed. The device is designed specifically for the pulmonic position. “Intended to prolong the time between open-heart surgeries for patients with a dysfunctional
Drugs
Hogan Lovells attorneys say that 2016 was a year of expansion for the False Claims Act (FCA). The firm’s first annual review of the act and its whistleblower provisions says there were “very significant changes to the way courts apply the FCA.” It references in particular a 6/16/
Devices
FDA says that the Medtronic 9/2016 recall of its SynchroMed implantable infusion pumps due to a software problem that may cause unintended delivery of drugs during a priming bolus procedure is Class 1. An agency notice says the SynchroMed II and SynchroMed EL implantable infusion pumps are programmed to
Devices
FDA has cleared a Medtronic 510(k) for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering designed to identify abnormal heartbeats. The device offers “exclusive algorithms that result in a 95% reduction in false bradycardia (slow heartbeat) episodes and a 47% reduction in
Devices
CDRH says it is expecting more collection of data on patient preference in device clinical trials. Asked a question during a recent teleconference (see transcript) on the agency’s final guidance on “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions,” CDRH policy analyst Karen