Devices
Former Becton Dickinson (BD) medical director Hooman Noorchashm has petitioned FDA to warn patients about the “unknown and inadequately studied effect” of FDA-regulated mesh products being implanted off-label in cosmetic mastopexy operations on the sensitivity of standard surveillance mammography and ultrasound for detection of breast cancer. Cardiac surgeon
Devices
Cardinal Health is recalling its latest version (6/2023) of its Monoject syringes branded as “Cardinal Health Monoject syringes” because their dimensions differ from the previously branded syringes and they may be incompatible with syringe infusion pumps. “The dimensional changes made to the affected Cardinal Health Monoject syringes when used
Devices
Covidien has recalled its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale illegally by unauthorized third parties. The devices had been previously assigned for destruction, but were stolen and sold on social media platforms, a recall notice says. “After the
Devices
FDA has cleared an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analytics tool that uses “AI/Deep Net/3D Convolutional Networks to support physicians as a clinical decision support tool for neurologists and neuroradiologists.” NeuroShield takes 3D magnetic resonance images
Devices
FDA has granted Brixton Biosciences a breakthrough device designation for its Coolio Therapy, which is intended to deliver long-lasting pain control in targeted areas with a single injection. The designation is based on data from animal models that the company says demonstrated the capability of the treatment to provide
Devices
FDA has granted Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry device for infants. It is designed, Owlet says, to monitor and display a baby’s “Live Health Readings,” including pulse rate and oxygen saturation level, and to provide health notifications
Devices
FDA is notifying healthcare providers about labeling updates to Becton Dickinson’s (BD) Phasix and GalaFlex mesh products, which were cleared for the repair and reinforcement of soft tissue where weakness exists. The agency says it has become aware of increased use of surgical mesh products in breast surgery, but
Devices
FDA has cleared an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency use in 2021. According to an FDA news release, Flowflex is the second home Covid-19 test to successfully complete a traditional FDA premarket review pathway. Notably, it
Devices
FDA has approved a PMA for Recor Medical’s Paradise ultrasound renal denervation system indicated to treat hypertension. The company says Paradise is intended as an adjunct treatment when lifestyle changes and medications have not adequately controlled a patient’s blood pressure. It is described as a first-of-its-
Devices
Becton Dickinson’s CareFusion unit has recalled (Class 1) its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible syringes’ labeling contains syringes that have not been validated. In a recent letter to users, the company told them to stop using certain Cardinal Health-branded Monoject syringes with
Devices
A 4/4-4/25 FDA inspection at Neurotris, Inc., doing business as A1 Engineering in Irvine, CA, determined the firm manufactures and distributes several unapproved Class 2 powered muscle stimulator devices, sometimes known as the Neurotris Body System. A 10/27 Warning Letter says the firm is illegally marketing
Devices
Johnson & Johnson says it intends to submit its Ottava robotic surgical system for an IDE in the second half of 2024 to open clinical trials. The company says Ottava is designed to create space in the operating room, simplify complex workflows, enable flexibility for clinical approaches, and deliver the
Devices
FDA has cleared a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes. “Prefilled syringes are proven to provide a significant improvement in ease of use for all patients, and in administering higher doses of immunoglobulin, including for PIDD [primary immunodeficiency disorder] and
Devices
FDA has reissued a guidance document entitled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices” that includes minor updates to align with the recent Consolidated Appropriations Act of 2023. The document describes the information that the agency will provide to a
Devices
FDA has cleared a Neurovalens 510(k) for its Modius Sleep device for treating chronic insomnia. The device is designed to improve insomnia by delivering a small electrical pulse to the head 30 minutes before bed, the company says, adding that users can do other activities (watching TV or reading)
Devices
CDRH says it has recognized and supports industry’s use of a key consensus standard to support device sponsors in their cybersecurity efforts. The standard in entitled “ANSI/AAMI SW96:2023 Standard for medical device security —- Security risk management for device manufacturers.” The Center says it “aligns with existing international
Devices
Teleflex and subsidiary Arrow International are recalling their Pressure Injectable Catheter Kits due to mislabeling about the presence of chlorhexidine in the products. The product code and product name are incorrectly listed as non-coated on the lids of the affected devices, a recall notice says. However, the banner card
Devices
FDA has cleared an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform — pulse and respiratory rate. “With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers for use in clinical trials,” Empatica says. The
Devices
FDA has issued a final guidance entitled “Enforcement Policy for Clinical Electronic Thermometers.” The agency describes clinical electronic thermometers as devices used to measure and monitor the body temperature of patients as an important screening and diagnostic tool to assist in identifying those who have a range of conditions or
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The attorneys general in 25 states are calling on FDA to act urgently to address the inaccuracy of pulse oximeters when used on people with darker-toned skin. In an 11/1 letter to FDA commissioner Robert Califf, the officials note that one year ago the agency held a public
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CDRH is soliciting public comment on a series of topics and questions about how digital health technologies (DHTs), including those enabled by artificial intelligence/machine learning, may help with the early detection of risk factors for Type 2 diabetes, prediabetes, and Type 2 undiagnosed diabetes. An online post says the
Devices
FDA has approved an Abbott molecular human papillomavirus (HPV) test for HPV screening and assessment of high-risk (HR) cancer-causing types of HPV. A company statement says the Alinity m HR HPV assay is also approved for use in combination with a Pap test for patients and doctors who