Devices
Medtronic has begun a Class 1 recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardiovert-Defibrillators due to a defect in the manufacturing process. The devices are intended to provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Affected devices
Devices
FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology have announced the availability of voluntary, standardized duodenoscope surveillance sampling and culturing protocols to help reduce the risk of infection and increase the safety of the medical devices. The protocols are an update to an interim
Devices
FDA has cleared an Access Vascular 510(k) for the HydroPICC, a peripherally inserted central catheter, intended for long-term use. In pre-clinical testing, the HydroPICC demonstrated a 30-times reduction in platelet count when compared with the current market-leading peripherally inserted central catheter, according to the company.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should abandon its efforts to develop a devices referencing drugs (DRD) pathway, while the Advanced Medical Technology Association (AdvaMed) strongly endorses the proposal. In its comment letter. PhRMA says DRDs “pose numerous significant public health, safety, scientific, regulatory, and legal issues
Devices
FDA has cleared a NeoTract 510(k) for new indications for the UroLift System to treat an enlarged prostate or benign prostatic hyperplasia. The expanded indications cover patients who have an obstructive median lobe and those as young as 45 years of age. Previously, the device was contraindicated in patients
Devices
FDA has cleared a Corindus Vascular Robotics 510(k) for the CorPath GRX System and its use in peripheral vascular interventions. The CorPath System is the only medical device to bring robotic precision to both percutaneous coronary intervention and peripheral vascular intervention procedures, the company says. During procedures, interventional cardiologists
Devices
A 2/20-2/22/17 FDA inspection at Pacific Hospital Supply, Miaoli, Taiwan, found Quality System Regulation violations in the firm’s manufacturing of disposable medical supplies including catheters, cannulae, tubing, and aspirators. A just-released 5/26/17 Warning Letter says violations noted on an FDA-483 were:
Devices
FDA will publish 2/21 an amendment to its regulations on accepting data from clinical investigations for medical devices. The agency says the change will require that data submitted from clinical investigations held outside the U.S. intended to support an IDE, 510(k), request for de novo classification, PMA,
Devices
Two medical device researchers have outlined in a 2/15 New England Journal of Medicine perspective piece the benefits and pitfalls of FDA relying on real world evidence (RWE) in regulatory decision making. The researchers reflect on a recent guidance on “Use of Real-World Evidence to Support Regulatory Decision-
Drugs
Writing for Washington Legal Foundation, two Fried, Frank attorneys say the time may be right to look again at constitutionality of the False Claims Act’s (FCA) qui tam (relator or whistleblower) provisions that allow a whistleblower to independently prosecute a False Claims Act case on behalf of the United
Devices
FDA has approved an expanded indication for the Concentric Medical Trevo clot retrieval device to allow treatment of certain stroke patients up to 24 hours after symptom onset, expanding the use to a broader group of patients. An agency news release says the device is cleared for use as an
Devices
FDA has authorized marketing of the Banyan Biomarkers Banyan Brain Trauma Indicator, a blood test used to evaluate mild traumatic brain injury (concussion). An agency news release says that most patients with a suspected head injury are examined using a neurological scale (Glasgow Coma Scale) followed by a CT head
Devices
FDA has granted Abiomed expanded PMA approval for the Impella 2.5 and Impella CP heart pumps and their use during elective and urgent high risk percutaneous coronary intervention procedures. The approval also eliminates an earlier requirement for depressed ejection fraction in the presence of severe coronary artery disease or
Devices
A 5/6-5/11/17 FDA inspection at Curasan AG, Frankfurt, Germany, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Cerasorb Dental, Cerasorb M Dental, Cerasorb Perio, Revios Implant System, IngeniOs HA (Osborne Dental), IngeniOs Beta-TCP Bioactive (Ceracell Dental), and Cerasorb Ortho
Devices
FDA has added new information to the labeling of warfarin international normalized ratio (INR) test meters for patients, caregivers and health care providers using the devices at home or in a clinical setting. The agency says it has received Medical Device Reporting-related adverse events about meters which may have
Devices
Philips Electronics has recalled its HeartStart MRx Defibrillator due to a defect in the device’s gas discharge tube. The tube has micro cracks which allow internal gasses to escape and cause the tubes to not function as expected, an FDA notice says. “This also permits an electrical current surge
Devices
FDA has cleared a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the company’s polymerase chain reaction testing platform, which is designed for point-of-care infectious disease diagnosis. The test provides a qualitative result in about 30 minutes. It is indicated
Devices
Attorney Elizabeth Minerd (Reed Smith) says an Illinois federal court took the time to sort through a number of novel plaintiff allegations in a case involving a Mentor silicone breast implant and determined that almost all of them were either expressly or impliedly preempted. Minerd writes in an online post
Drugs
Four stakeholders are praising FDA’s 1/16 notification of an indefinite delay in the effective date of a final rule setting forth a new method for determining the intended use of medical products. The stakeholders say the delay is warranted given the controversy over a provision in the rule
Devices
The DC federal court has granted in part and denied in part Medtronic’s motion for summary judgment in a case involving a mechanical pump and associated infusion set used to administer insulin to a diabetic woman. The woman, a college sophomore in 2007, experienced severe hypoglycemia in her dorm
Devices
FDA says Pentax has recalled all of its ED-3490TK duodenoscopes to replace the forceps elevator, O-ring seal, and distal end and cap, and to update the operation manual to recommend annual maintenance. An agency post says the design changes are intended to reduce the potential for leakage of
Devices
FDA has released the FDA-483 issued following a 10/2-10/16/17 inspection at Zimmer Biomet’s manufacturing facility in Warsaw, IN. Specific observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately establish procedures to control product that does not conform to