Devices
Cook Medical has recalled almost 9,000 Roadrunner UniGlide Hydrophilic Wire Guides after its hydrophilic coating supplier, DSM Biomedical, recalled certain lots of material due to concerns about a potential contamination by glass particles. Potential adverse events that may occur as a result of this contamination could include vessel damage,
Devices
FDA’s Clinical Chemistry and Toxicology Devices Panel of the Medical Devices Advisory Committee has unanimously voted to recommend that the benefits from the use of Baebies’ Seeker System outweigh the risks in the intended use population. The device comprises a SEEKER Analyzer, a SEEKER 4-Plex Assay Kit, SEEKER
Devices
FDA has approved an Edwards Lifesciences PMA for its Intuity Elite valve system, a rapid deployment device for surgical aortic valve replacement. Built on the company’s Perimount tissue valve platform, the device is supported by data from the TRANSFORM clinical trial, which treated 839 patients in 29 centers in
Devices
FDA has posted two final guidances on electrosurgical device submissions. The guidance on Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery is intended for devices designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high-
Devices
BioMerieux has begun a Class 1 recall of its NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. “Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance
Devices
The Advanced Medical Technology Association (AdvaMed) says FDA’s draft guidance on “Technical Considerations for Additive Manufactured (AM or 3-D Printed) Devices” is confusing regarding recommendations on patient-matched devices (patient-specific, personalized or customized). In just-posted comments to the agency, AdvaMed says that to “mitigate this confusion,
Devices
FDA has cleared a D R Burton Healthcare Products 510(k) for its iPEP system, an oscillating positive expiratory pressure product. The device is intended to measure patient inspiratory capacity, according to the company. It combines two standard of care therapies — “the inspiratory capacity measurement associated with an incentive spirometer
Devices
Sanuwave Health has submitted a de novo petition requesting CDRH review and classification of the dermaPACE System for treating diabetic foot ulcers as a Class 2 device. The submission is based on data from two clinical trials involving 336 patients. The trial’s primary endpoint was wound closure, which was
Devices
FDA has cleared a Centric Medical 510(k) for the Hammertoe Correction System. The device offers a dual threaded design and is inserted between the proximal and middle phalanges, so that the opposing threads fixate on the phalangeal canal of the toe and compress the joint, according to the company.
Devices
Medical Compression Systems has obtained 510(k) clearance for its new comprehensive monitoring application, in combination with ActiveCare, a device used for preventing deep vein thrombosis prevention in total joint patients. The online platform is equipped with Bluetooth to allow wireless data transmission between patients and their healthcare providers.
FDA Policy/General
A study focused on medical device company representatives in surgical suites says there are “ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.” The research was reported in the open-
Devices
FDA has approved a Boston Scientific PMA for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD Systems. “Now with FDA approval, patients receiving the Emblem MRI S-ICD System, as well as patients who
Drugs
Presumably tired of waiting for FDA to make sense of its position on off-label promotion given many First Amendment losses in the courts, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have issued their own industry practice principles on off-label communications. Attorney James
Devices
The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee meets August 16 to consider over-the-counter diagnostic tests for detecting pathogens causing infectious diseases. An agency executive summary released in advance of the meeting says the panel will discuss the risks and benefits of OTC diagnostic tests
Devices
A new report indicates that many medical device makers are not ready to implement Unique Device Identification (UDI) labeling based on FDA compliance deadlines. For example, next month the labels and packages of Class 2 devices must bear a UDI, according to the agency. However, the report from Loftware and
Drugs
Improved research and technology development, combined with general advances in biological and information technologies, should accelerate improvement in cardiovascular outcomes, opines FDA commissioner Robert Califf in an 8/8 Journal of the American College of Cardiology article. “But if we are to harness these technologies and apply them effectively, our
Devices
A California state court has allowed a series of product liability lawsuits to proceed against Bayer by 14 women who allege that they have been injured by the company’s birth control device Essure. The suits contend that the device can come out of place and puncture the uterus, and
Devices
FDA is keeping its popular flowcharts in a new draft guidance that updates recommendations on when device makers need to submit a new 510(k) after making device modifications. The guidance has been three years in the making after the agency held a public stakeholder meeting in 2013 on revamping
Devices
Dräger has begun a Class 1 recall of its VentStar Oxylog 3000 Pediatric Patient Breathing Circuit after it was discovered that the check valve on the circuit may leak. “This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels,” a recall
Devices
FDA is seeking comments on a final set of PMA product codes that have been identified under a two-year retrospective review as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in data collection from premarket to postmarket. Analyzing the Class
Devices
Four Hogan Lovells attorneys say that the success of a recent FDA draft guidance on using real-world evidence to support regulatory decision-making for medical devices will depend on the agency’s openness to accepting proposed real-world evidence despite its limitations. Writing in an online blog post, the
Devices
FDA has cleared an EndoChoice Holdings 510(k) for the Lumos with Adaptive Matrix Imaging, a proprietary imaging software system that is part of the company’s Generation 3 Fuse Full Spectrum Endoscopy System. The software is intended to analyze and selectively enhance the vascularity, surface texture, and color of