Drugs
The Senate Health, Education, Labor and Pensions Committee 2/9 favorably voted out seven bipartisan bills on biomedical innovation. Despite the favorable votes, there remains a divide on providing FDA and NIH with funding to implement the measures. The next HELP meeting is scheduled for 3/9, where the committee
Devices
Members of the FDA Circulatory System Devices Advisory Panel meet 2/18 to discuss and make recommendations on clinical trial, post-approval study design, and physician training for leadless cardiac pacemaker device technology. A briefing document released in advance of the session says that specifically the committee will be asked
Devices
CDRH associate director for digital health Bakul Patel says the Center has taken steps to encourage interoperability of medical devices as a way to improve patient care and reduce errors. Writing in an FDA Voice blog post, Patel defines interoperability as the “rapid transfer and use of information between and
Devices
FDA has cleared a LifeWatch AG 510(k) for its continuous Vital Signs Monitoring Service, a wireless patch intended to allow for early detection of vital sign changes. Notifications on vital sign changes can enable faster interventions as well as increased nursing efficiency and higher patient satisfaction, according to the
Devices
CDRH has posted a draft guidance on “Display Devices for Diagnostic Radiology” to assist industry in preparing premarket notification submissions for display devices intended for use in diagnostic radiology. The document is intended to apply to current technologies, but the Center says it may request new or alternative test methods
Devices
FDA has posted a final guidance on “Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays” that discusses information to include in premarket notifications for assays for the anti-seizure drugs. The assays are intended to quantitatively measure concentrations of the respective drugs in serum or plasma as an aid
Devices
FDA has cleared a Spectranetics 510(k) for the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures. The device is designed to reduce blood loss if a tear occurs, including in the superior vena cava (SVC). The company says an SVC tear occurs in less than
Drugs
The Obama Administration says its “open data” initiative remains a priority in 2016. A White House blog posting acknowledges various OpenFDA updates, including direct downloads that enable citizens to use data on food, drug, and medical device safety. Open data from government agencies is an “important national resource, serving as
Devices
FDA has approved Medtronic’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan defibrillators for patients requiring magnetic resonance imaging (MRI). The approvals cover MRI scans on any part of the body without positioning restrictions, the company says. Until now, CRT-Ds have been contraindicated
Drugs
A U.S. Supreme Court decision last June involving First Amendment arguments in a case about township sign codes has certain implications for how FDA regulates off-label promotion, according to Reed and Smith attorneys. Writing in a recent Washington Legal Foundation Legal Backgrounder, they say the decision “significantly affects
Devices
Sen. Patty Murray (D-WA) has introduced the Preventing Superbugs and Protecting Patients Act to give FDA additional tools to review and ensure the safety of medical devices and contaminated duodenoscopes that were linked to life-threatening antibiotic-resistant infections. Murray says an investigation she led showed that manufacturers of
Devices
An Oklahoma federal court ruled 1/28 that a suit against Boston Scientific over a Class 3 spinal cord stimulator was expressly preempted under provisions of the Medical Device Amendments of 1976. Attorney Michelle Yeary (Dechert) writes in an online post that the court found that the plaintiff’s allegations
Devices
At the 1/11 MDUFA 4 reauthorization patients and consumer stakeholder meeting, FDA reviewed the current status of a number of proposals and addressed clarifying questions from stakeholders. Meeting minutes indicate that the agency identified the places of commonality in proposals posed by it and industry such as with de
Devices
FDA has cleared a Focal Healthcare 510(k) for its targeted prostate biopsy device, Fusion Bx. The device is intended to assist clinicians in taking targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology, according to the company. “MRI has the ability to see
Devices
FDA has issued two guidances dealing with human factors in medical devices. The first, a draft guidance, List of High Priority Devices for Human Factors Review, is to inform medical device manufacturers which device types should have human factors data included in premarket submissions. The document says that the agency
Devices
FDA has issued a draft guidance, Enforcement Policy of National Health Related Item Code and National Drug Code Numbers Assigned to Devices, describing the agency’s intent not to enforce before 9/24/21 the prohibition against providing National Health Related Item Code or National Drug Code numbers on device
Devices
Booz Allen Hamilton says that its evaluation of CDRH’s progress in implementing the consulting firm’s recommendations for improving the review of medical device premarket submissions shows that the Center successfully completed Stage 1 for each project in its Plan of Action to address the consulting firm’s recommendations.
Devices
Beginning this month, CDRH will accept global unique device identifier database (GUDID) account requests from labelers of Class 2 devices. “FDA’s experience and feedback from industry indicate that device labelers often take a number of actions to organize, collect and validate data — before they get a GUDID account or
Devices
FDA has approved a LivaNova PMA for its stented aortic bioprosthesis Crown PRT for treating aortic valve disease. The device features a “surgeon-friendly design, optimizing hemodynamics and the patented Phospholipid Reduction Treatment (PRT), which was designed to enhance valve durability,” the company says. The valve also allows, it says,
Devices
FDA has posted a transcript of a 1/21 Webinar detailing CDRH’s recent guidance on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings. “The terminology used to describe gowns has evolved, making it important for both industry and gown users to have a clear and
Devices
Arkray Factory has begun a Class 1 recall of its SpotChem II Test Strips due to inaccurate blood sugar readings. The reagent test stripa are used to glucose levels in blood samples, and are used with the SpotChem EZ analyzer. A recall notice says the strips are falsely showing low
Drugs
Washington Legal Foundation (WLF) says that recent federal appeals court decisions suggest that the Supreme Court’s 2011 decision in Sorrell v. IMS Health has led to an expansion of commercial speech. A WLF online Legal Pulse says that the high court held in Sorrell that content- or speaker-based