Devices
Philips Respironics is recalling (Class 1 device correction) its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regarding the use of in-line nebulizers. An in-line nebulizer is an accessory that converts therapeutic liquids (such as medication/saline solutions) into an aerosol to treat different
Devices
Advanced Medical Technology Association (AdvaMed) says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices it identifies, as well as ongoing input on how to incorporate the considerations and strategies outlined in a recent discussion paper entitled “Health Equity For Medical
Devices
Medtronic is recalling (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations. “Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life,” a recall notice says. “Since the
Devices
FDA has cleared an Elucid 510(k) for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease. The software is designed to “objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques,” the company says, adding that it is intended
Devices
FDA has updated CDRH’s Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination (SBD) requests. An agency notice says CDRH’s portal can now track the progress of PMA applications and PMA Panel-Track supplements. “Users can view their application status in near
Devices
FDA has cleared an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in the supine position. The device provides information for surgeons to accurately position each patient’s hip components based on their unique anatomy, the company says. “Next-generation accelerometers
Drugs
The Combination Products Coalition (CPC) says FDA should change its draft guidance on essential drug delivery outputs (EDDOs) for devices intended to deliver drugs and biological products to offer companies greater flexibility in determining how to implement the concepts in the guidance. “In particular,” the coalition comment letter says, “we
Devices
FDA says the Philips Respironics 7/16 mandatory software correction and updated use instructions for its Trilogy Evo, EV300, EvoO2, and Evo Universal ventilators is a Class 1 recall. An agency 10/1 notice says the corrections were made to resolve several previously reported and also new safety issues that
Devices
FDA has approved a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging technology for its Mammomat B.brilliant mammography platform. The approval includes new 3D image acquisition and image reconstruction technology, according to the company. The device features a 50-degree wide-angle technology to overcome the
Devices
The Association for Molecular Pathology (AMP) and the American Clinical Laboratories Association have asked a Texas federal court for summary judgment against FDA in their suit challenging the agency’s final rule that asserts authority to regulate laboratory-developed tests (LDTs). The motion reiterates the associations’ arguments against the FDA
Devices
Fresenius Kabi is recalling (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software anomalies and a cybersecurity vulnerability that have the potential to result in a therapy delay or under dosage. The use of affected product may cause serious adverse health consequences, including
Biologics
FDA has published a guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, with help for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic systems, records, and signatures in clinical investigations of medical products, new animal drugs,
Drugs
Sen. Bill Cassidy (R-LA) is asking FDA to explain why it has failed to provide clarity to drug manufacturers on properly listing their products’ patents in the Orange Book. In a 9/30 letter to FDA commissioner Robert Califf, Cassidy says that for decades, brand and generic drug manufacturers
Devices
FDA has approved Establishment Labs Holdings’ Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for primary and revision breast augmentation. The devices feature the patented SmoothSilk surface, which is designed for “enhanced biocompatibility and scientifically shown to promote low inflammation,” the company says. The Motiva SmoothSilk Ergonomix device is
Devices
CDRH has issued four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program. They are: 1. Dental Air-Powered Dental Handpieces and Air Motors 2. Dental Cements 3. Dental Ceramics 4. Dental Impression Materials CDRH says that under the pathway, device manufacturers planning to submit
Devices
Two U.S. House of Representatives Democrat lawmakers are calling for an HHS Office of Inspector General (OIG) investigation into potential conflict-of-interest appearances (see story) raised in last month’s New York Times investigative article on retiring CDRH director Jeff Shuren’s regulatory role and the legal work
Devices
FDA has cleared a Piur Imaging 510(k) for the Piur tUS Infinity, which the company says is an advanced ultrasound technology that changes existing 2D ultrasound devices into 3D systems for thyroid imaging. “This cutting-edge technology provides clinicians with highly detailed volumetric datasets of thyroid lobes and nodules
Devices
FDA has cleared a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter, the newest addition to the company’s Introcan portfolio. The device provides automatic passive safety needlestick protection and multi-access blood control in longer lengths than its earlier version of the device,
Devices
FDA has appointed former Olympus Medical Systems chief medical officer Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing William Maisel who retired earlier this year and is now senior medical officer at robotics company Intuitive Surgical. During his time at Olympus, Segan likely dealt with significant
Devices
[Analysis by Jim Dickinson] Physician-attorney Jeff Shuren is gone from CDRH but his hand-picked interim successor, deputy director Michelle Tarver, continues his cozy-with-industry corruption of FDA’s patient safety mission at the Center. A troubling part of their legacy is the broken lives of patients devastated
Devices
FDA has issued three medical device-related draft guidances about the agency’s Accreditation Scheme for Conformity Assessment Program. They are: * The Accreditation Scheme for Conformity Assessment (ASCA) Program — FDA announces that it has concluded its earlier ASCA pilot phase and is establishing an ongoing ASCA Program. FDA believes the
Devices
Smiths Medical is recalling (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors may become loose or detach altogether, which will impact active ventilation. “If the patient outlet connector is loosened or detached it could cause extended interruption of therapy, no ventilation,