Devices
FDA has issued a Warning Letter to Invisi Smart Technologies (United Kingdom) over its Invisi Smart Mask for sale in the U.S. without a cleared 510(k). FDA contacted the firm 10/2020 about submitting a premarket notification. As of 6/21, FDA says no submission has been received
Devices
FDA says Baxter has issued an urgent medical device correction for all its Spectrum IQ infusion pumps to reinforce important safety information when customers implement changes to their network configuration and server systems. An agency online notice says two customers notified Baxter of system errors occurring in multiple pumps in
Devices
FDA has announced a 10/14 virtual public workshop on improving transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices for patients, caregivers, and providers. The workshop is intended to focus on information sharing methods such as labeling to improve transparency. It will gather input from various stakeholders
Devices
FDA is alerting health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. because the company did not implement, maintain, and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of
Devices
FDA has approved a sNDA extending to seven years the duration of use for pregnancy prevention of Bayer’s Mirena (levonorgestrel-releasing intrauterine (IUD) system) 52 mg. The company says the approval was based on the results of a Phase 3 extension trial evaluating Mirena’s safety and efficacy. Bayer
Devices
FDA has issued an emergency use authorization (EUA) for the BD Veritor at-home Covid-19 test. The company says Veritor is the first at-home rapid antigen test to use a smartphone to interpret and provide a digital display of test results. “The test does not require a prescription,
Devices
FDA has classified as Class 1 a Bio-Medical Equipment Service Co. recall of the Alaris Infusion Pump Module Model 8100 pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly due to the potential for the bezel components to crack or separate. The separation of one or
Devices
FDA has approved a Medtronic PMA for its next-generation, self-expanding transcatheter aortic valve replacement (TAVR) system — the Evolut FX TAVR system. The device is designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the company says. It is equipped with gold markers
Devices
FDA has granted a de novo authorization to Siemens Healthineers for its Enhanced Liver Fibrosis (ELF) Test and its use with the Advia Centaur XP Immunoassay System to provide a simple numeric score that is automatically generated via an algorithm. The test is intended to be used to improve patient
Devices
Cardinal Health has recalled (Class 1) its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalpel N11 contained in the tray. The scalpel has a permanent locking feature that will not allow a clinician to unlock the scalpel once they have closed the
Devices
Cardinal Health has recalled three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the syringe after a health care provider has pushed out air. A recall notice says that the materials used to make the syringe let the plunger slip back in the
Devices
FDA has issued a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer has not been established. In addition, FDA says it is aware of reports
Devices
FDA has granted 510(k) clearance to medical image artificial intelligence provider Qure.ai for its brain CT quantification product qER-Quant. The company says clinicians can use the tool to rapidly and precisely assess the severity of injury in patients with conditions like traumatic brain injury, hemorrhagic stroke, and
Drugs
The Sedgwick recall index for the second quarter of 2021 shows drug and medical device recalls continuing to go down. The report says that medical device recalls fell for the fourth consecutive quarter, down 18.4% from the first quarter (212 recalls to 173), for a nine-quarter low. Software
Devices
FDA has cleared a Zimmer Biomet 510(k) for its Rosa Hip System for robotically-assisted direct anterior total hip replacement. The Rosa Hip is the fourth robotic system introduced by Zimmer Biomet and adds to the company’s product lines: Rosa Knee System for total knee arthroplasty, Rosa Partial
Devices
FDA has cleared a CardioNXT 510(k) for its heart treatment delivery platform, comprising the company’s iMap 3D Navigation & Mapping System, Activate Software, Sensor Enabled Axis Patient Patches, and MultiLink Sensor Enabled Catheter. The platform enables the examination of problematic cardiac tissue that is causing arrhythmias and directs
Devices
AdvaMed has commented on a CDRH discussion paper on “Conveying Materials Information About Medical Devices to Patients Healthcare Providers: Considerations for a Framework.” The trade association’s comments deal with the general framework, healthcare providers and patient labeling considerations, and materials listings.
Devices
FDA has issued a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical due to a risk of bacterial contamination with Burkholderia cepacia complex. The affected products are distributed by a number of companies under various product names,
Devices
FDA has granted a breakthrough designation to Abiomed’s Impella ECP expandable percutaneous heart pump. The device is placed percutaneously into the heart’s left ventricle to expand and support the heart’s pumping function, providing flow greater than 3.5 L/min, the company says. Impella ECP is the
Biologics
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) has three takeaways from the recent FDA final rule governing how the intended use of a distributed product is to be determined. First, he says in an FDA Law Blog post, the removal of the knowledge provision, which had seemed to problematically suggest
Devices
FDA says it is aware of potential confusion and the possibility of inappropriate medical treatment based on the color of the bracelet or wristband provided by a medical device manufacturer and given to patients to be worn as an identifier of an implanted device. An online notice says in 2008
Devices
FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system. The device consolidates 360-degree cone-beam computerized tomography, fluoroscopy, and high-resolution digital radiography into one unified application. It is indicated for use when a physician benefits from 2D and 3D