Devices
FDA has published a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, describing recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The document says the recommendations are intended to improve the consistency and reliability of analytical chemistry studies and are based on FDA’s
Devices
FDA has cleared a Forest Devices 510(k) for the SignalNED Model RE System, a device that uses electroencephalogram (EEG) technology to analyze a patient’s brain to provide clinicians with relevant information about their neurologic state. It “utilizes a novel, rapidly deployed EEG headset (the Sensor Cap) along with
Devices
Braun Medical is expanding an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to previous recalled devices — Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless Battery Pack — due to the risk that an alarm may sound to indicate an occlusion when
Biologics
The Institute for Clinical and Economic Review (ICER), a private, independent, nonprofit research institute, says that while it applauds FDA’s continued effort to create policies and guidance to enhance greater diversity in clinical trials, it is concerned about the stated intended goal of a draft guidance on diversity action
Devices
Smiths Medical is recalling (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect that may cause the device’s securement flange to tear. “The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of
Biologics
FDA has published a guidance, Conducting Clinical Trials with Decentralized Elements, with recommendations for sponsors, investigators, and other interested parties about implementing decentralized elements in clinical trials. The document says decentralized elements can include telehealth, visits with trial personnel, in-home visits with remote trial personnel, or visits with local
Devices
FDA has issued a safety alert about an increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System). In July, the company began a recall to update the device’
Devices
Fresenius Kabi is recalling (Class 1) one lot of the Ivenix Large Volume Pump (LVP) primary administration sets after documenting a manufacturing defect that may cause uncontrolled medication flow. “The use of affected product may cause serious adverse health consequences, including medication overdose and death,” a recall notice says. To
Devices
FDA has cleared a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identifying cells, vessels and their architecture. The device is designed to provide real-time, high-resolution imaging of fresh tissue surfaces, offering surgeons and pathologists the information for excised tissue,
Devices
FDA has authorized the first over-the-counter hearing and software device that is used with compatible versions of the Apple AirPods Pro headphones. An agency statement says that the authorized Apple Hearing Aid Feature (HAF) enables compatible versions of the AirPods Pro to operate as an over-the-counter
Devices
FDA has sent Warning Letters to Mid-Link Testing Company in Tianjin, China, and Sanitation & Environmental Technology Institute of Soochow University in Suzhou, China, about laboratory oversight failures and animal care violations. An agency statement (contains links to the letters) says the firms provide third-party testing and validation
Devices
FDA has cleared a Hinge Health 510(k) for its Enso 3, a wireless device that the company says is clinically proven to reduce musculoskeletal pain. “The new Enso 3 delivers electrical nerve stimulation that achieves non-invasive, non-addictive pain relief within minutes,” it says. The clearance was based
Devices
A 2/26-3/1 FDA inspection at the Optikem International facility in Denver, CO, found multiple violations in the firm’s manufacturing of the Sereine brand of ophthalmic medical device solutions. A just-released 8/13 Warning Letter says the products are adulterated due to Quality System regulation violations.
Drugs
The Medical Information Working Group (MIWG) says it has concerns about a revised FDA question-and-answer draft guidance on addressing misinformation about medical devices and prescription drugs. In its comment, the MIWG says that despite improvements made in the current revision, it still has concerns about the guidance’s
Devices
FDA has granted 510(k) clearance to Sonic Incytes Medical Corp’s Velacur Determined Fat Fraction, a measuring tool the company says is integrated into the Velacur device software combining quantitative measures of ultrasound attenuation and backscatter. A company statement says device results correlate well with the MRI proton density
Drugs
Attorneys Wyatt Kernell and Sonia Nash (Cooley) say companies should carefully review an FDA 7/8 draft guidance on addressing misinformation about medical devices and prescription drugs as part of preparing any tailored response communication to be sure their communication falls within the agency’s enforcement discretion policy. Writing in
Devices
FDA has cleared a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments for reducing stress, and as an adjunctive treatment for high blood pressure when used with other pharmacological or nonpharmacological interventions. DeepWell says it will make the new technology
Devices
FDA has cleared a Femasys 510(k) for FemChec, a diagnostic device for checking the fallopian tubes. “When used with an intrauterine catheter, it is intended for the controlled delivery of natural contrast during an ultrasound evaluation of the fallopian tubes with or without the uterine cavity,” the company says.
Devices
The Association for Diagnostics and Laboratory Medicine (ADLM) is voicing significant concerns regarding the recent FDA final rule on laboratory developed tests (LDTs), and it is urging Congress to intervene while judicial reviews determine the agency’s authority to regulate LDTs. ADLM also urges Capitol Hill to explore separate solutions
Devices
FDA has cleared an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence technology to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. The Caddie computer-aided detection device was cleared based on data from a randomized controlled trial
Devices
FDA has published a draft guidance, Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, with recommendations on how voluntary patient preference information (PPI) may be considered by FDA staff in medical device decision-making. The document’s objectives are to: * encourage submission of PPI, if available, by
Devices
Abbott Diabetes Care is recalling (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes. The sensors are used in Abbott’s