Devices
FDA has given an additional 510(k) clearance to Anika Therapeutics’ Tactoset injectable bone substitute. The company says the new indication expands the use of Tactoset to include augmentation of hardware and the support of bone fragments during surgical procedures. Anika describes Tactoset as a calcium phosphate-based, biocompatible bone
Devices
FDA has classified as Class 1 an Eco-Med Pharmaceutical recall of all ultrasound gels and lotions manufactured by the company 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, including MediChoice Ultrasound Gel
Devices
FDA says it has initiated on-site inspections at Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements, following a recent Class 1 recall of its continuous and non-continuous ventilators due to concerns about the polyester-based polyurethane sound abatement foam, which is used to reduce sound and
Devices
FDA has granted breakthrough device designation to the Novocure Novo TTF-200T system, a tumor treating fields (TTFields) delivery system intended for use with Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) for the first-line treatment of patients with unresectable or metastatic liver cancer. The company says the designation was
Devices
FDA’s Medical Device Single Audit Program (MDSAP) has released a document, Guidelines on the Use of Quality Management System—Medical Devices—Nonconformity Grading System for Regulatory Purposes and Information Exchange. The guideline is intended for regulatory authorities and auditing organizations participating in or using the results of the MDSAP.
Devices
FDA has cleared a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion procedures for various diseases of the lumbar spine, such as degenerative disc disease. The 3D printed titanium products are designed for bone ingrowth, and are fillable with bone or
Devices
FDA has approved a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death. The OCS Heart is a portable, warm perfusion, and monitoring system designed to keep a donor heart at a human-like, metabolically active state, the company says. By monitoring
Devices
FDA has cleared a NeuroOne Medical Technologies 510(k) for its Evo sEEG Electrode technology for temporary (less than 24 hours) use for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. The electrodes are an alternative to cortical electrodes, which require removal of the
Devices
FDA has cleared a Molekule 510(k) for its existing air purifier, Air Pro, classifying it as a Class 2 medical device for medical use for the destruction of viruses, bacteria, and mold. It joins the company’s Air Mini, Air Mini+, and Air Pro RX products, which are also
Devices
FDA has cleared an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care. The matrix comprises hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes, the company says. “When applied to a wound surface,
Devices
FDA has cleared an Asensus Surgical 510(k) to expand the machine vision capabilities on its previously cleared Intelligent Surgical Unit (ISU), which is used with the company’s Senhance Surgical System to enable digital laparoscopy. “The current features of the ISU enable machine vision-driven control of the camera
Drugs
FDA has added information in a revised guidance about remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitoring should audit the remote monitoring once Covid restrictions are lifted. The re-monitoring discussion is contained in the appendix and the just-revised guidance entitled Conduct of
Devices
FDA has cleared a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures. The device features a low insertion profile (4mm) and long expansion (18mm) in a single implant, the company says. The expandable implant, which allows for 2.5cc of
Drugs
FDA has revised its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency. The document provides general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity for the duration
Devices
FDA has granted de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart knee for total knee replacement surgery. Persona IQ combines Zimmer Biomet’s Persona Personalized Knee, with Canary Medical's proprietary implantable canturio te tibial extension sensor technology
Devices
FDA has release a draft guidance entitled Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway. The screw systems that are the subject of the guidance comprise metallic bone screws and optional washer components. The devices are unclassified and are identified with the product code MRW (system, facet
Devices
FDA has posted a draft guidance entitled Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway. The document provides performance criteria for denture base resins for those using the pathway to market. Under the framework, 510(k) submitters have the option to use the performance criteria proposed in
Devices
A new study by FDA researchers supports an agency recommendation earlier this year that patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least six inches away from implanted medical devices, especially pacemakers and cardiac defibrillators. The study, published by the
Devices
FDA has approved a MicroTransponder PMA for the Vivistim Paired VNS System, a rehabilitation device intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS). “To use the Vivistim System, an implantable pulse generator (IPG) — which generates a mild electrical
Devices
A Minnesota federal court has granted summary judgment in a whistleblower case alleging that Boston Scientific fraudulently induced FDA to approve two types of defibrillators that were later recalled. Three Sidley Austin attorneys write in an online post (contains a link to the court decision) that the federal government had
Drugs
FDA has approved a Servier Pharmaceuticals sNDA expanding the indication of Tibsovo (ivosidenib tablets) to treat adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-approved test. At the same time, the agency gave premarket approval to Thermo
Devices
FDA has cleared a Fuse Medical 510(k) for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert, both additions to the Sterizo Total Knee System. The Tibial Revision provides surgeons a stemmed option in a primary total knee arthroplasty for patients with higher body mass