Devices
An FDA safety alert warns patients and health care providers about the risk of injury that may happen to patients if the cold-therapy mode of water-circulating hot/cold therapy devices is not used correctly. “Patients who use these devices may get injuries from the cold, such as temporary
Devices
FDA has cleared a Roche 510(k) for the cobas BKV Test and its use on the cobas 6800 and 8800 Systems. The test is intended to provide standardized, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant
Devices
FDA has approved an early feasibility study for Medtronic’s Intrepid Transcatheter Tricuspid Valve Replacement system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged, or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber, causing eventual heart failure
Devices
FDA is inviting feedback on information and features that submitters would find useful in a new progress tracker for premarket submissions the agency is developing. An online notice says FDA “is building a secure, Web-based tracker that displays the progress of a medical device marketing submission throughout FDA’s
Devices
FDA has posted a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process. The document is intended to provide further clarification and updated information on the ISO standard to support applications submitted to FDA.
Devices
FDA is reminding healthcare providers that it is important to conduct a trial stimulation period with patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS). An agency letter to healthcare providers says that as part of FDA’s ongoing monitoring of the safety and effectiveness of
Devices
FDA has cleared a SoftWave Tissue Regeneration Technologies 510(k) for using its SoftWave technology for treating superficial, partial-thickness, second-degree burns in adults. SoftWave technology uses an unfocused extracorporeal shock wave to “promote both a physical and biological response in order to improve wound healing,” the company says,
Drugs
FDA has denied two of three issues raised in a 1/14/2013 petition filed by the law firm of Kleinfeld, Kaplan and Becker. The petition asked that the agency (1) reconsider and rescind the 5/16/2012 510(k) clearance for the GeNOsyl MV-1000; (2) require NDA approval
Devices
FDA says that of four scenarios described in a Becton Dickinson (BD) 6/30 recall of its BD Alaris infusion pump system, three of the scenarios are Class 1 and one is Class 2. The classifications are included in a recall update. BD said it initiated the recall to notify
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) identifies two reasons supporting the recent HHS announcement that FDA will no longer conduct premarket review of laboratory-developed tests (LDTs). Writing in his firm’s FDA Law Blog, Shapiro says the reasons are that: * clinical laboratories will no longer be under the
Drugs
An assessment of combination product review practices under PDUFA 6 indicates that the practices are generally considered by the product sponsors and agency reviewers to be effective and efficient despite some challenges. The just-released 8/7 assessment by Lexington, MA-based Eastern Research Group, Inc. says: * request for determination
Devices
International Contrast Ultrasound Society (ICUS) has petitioned FDA to remove Boxed Warnings from ultrasound contrast agents (UCAs), citing scientific data to demonstrate product safety and life-saving potential. “It is now abundantly clear that UCAs are extremely safe, and that they may save lives and lower overall diagnostic imaging costs,
Devices
FDA has approved Medtronic’s MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in individuals aged two to six with Type 1 diabetes. The 770G System is a Bluetooth-enabled version of previously approved MiniMed
Devices
FDA has granted Baxter International a de novo application for the Theranova dialysis membrane. The company says the device was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis filters, like high-flux membranes, by “targeting effective removal of conventional
Devices
FDA has issued a draft guidance on Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. The document discusses best practices for incorporating patient-reported outcome (PRO) instruments throughout a medical device’s lifecycle. It touches on the qualities of PRO instruments
Devices
FDA has granted Synchron a breakthrough device designation for Stentrode, an implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel without the need for open brain surgery. The device is currently being evaluated for its ability to enable patients with paralysis
Devices
FDA 8/28 issued an alert to healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-based Laws of Motion PPE.com until further notice because they may not provide their labeled level of protection, including fluid barrier protection. The agency’s
Devices
FDA has cleared a B. Braun Medical 510(k) for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within magnetic resonance imaging (MRI) suites. The device is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to
Devices
FDA has granted an emergency use authorization (EUA) for the Abbott BinaxNOW Covid-19 Ag Card, described as a fast, $5, 15-minute, easy-to-use Covid-19 antigen test. The company says it is offering a no-charge complementary phone app that allows people to display their BinaxNOW test
Devices
FDA has approved Foundation Medicine’s FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test. The company says the approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP (poly ADP ribose polymerase) inhibitor approved in a prostate cancer setting, and three tyrosine kinase inhibitors for non-small
Devices
Public Citizen is suing FDA to compel the agency to respond to the advocacy group’s 2015 petition asking that Baxter’s Seprafilm Bioresorbable Membrane be banned. Seprafilm is a material used by surgeons during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissue that
Devices
A new Internet of Things (IoT) vulnerability discovered by IBM’s X-Force Red hacker team could affect many Internet-connected devices, including medical devices, according to a Security Intelligence post. The hacker team reportedly found a vulnerability in a module used in many devices. The affected Thales modules are