Devices
FDA has approved a Shockwave Medical PMA for what the company calls an “enhanced” Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter, indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Shockwave says the device provides 50% more pulses per catheter
Devices
Philips Respironics is recalling (Class 1) its V60 Ventilators and V60 Plus Ventilators because the devices contain power management printed circuit board assemblies that do not meet ventilator standards. “The use of the affected ventilators may cause serious adverse health consequences, including power failure, loss of ventilator function, and death,
Devices
A Chinese citizen was arrested 10/19 on a criminal complaint about manufacturing and distributing misbranded medical devices in violation of the Food, Drug, and Cosmetic Act and making false statements to FDA. A government release says Jia Bei Zhu (formerly of Clovis, CA), changed his name, the names of
Devices
FDA has cleared a Cardio Flow510(k) for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. The device is designed with a “modern mechanism of action” to clear plaque blockages in leg arteries, according to the company. “This proprietary, catheter-based design leverages the physics of angular momentum, creating a
Devices
FDA has added 171 medical devices to its list of artificial intelligence (AI) and machine learning (ML)-enabled devices legally marketed in the U.S. by 510(k) clearance, de novo request, or premarket approval. Of the new additions to the list, 155 are devices with final decision dates between
Devices
FDA has granted SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device (SCD) for use in intensive care unit patients with acute kidney injury and acute chronic liver failure. “Hepatorenal syndrome is characterized by an abrupt deterioration of kidney function, driven by a hyperinflammatory process
Devices
Hamilton Medical is recalling its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventilator’s control board. “If the control board contacts the electrolyte fluid, the control board or installed spare parts could short circuit,” a recall notice says. The short circuit could
Devices
Seven Gibson Dunn attorneys say cybersecurity is a major focus for government False Claims Act (FCA) investigations. Writing in an online post, the attorneys say that in light of recent new medical device cybersecurity requirements, content in premarket submissions to FDA on cybersecurity procedures and disclosures “constitute another area of
Devices
FDA has published a guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring, to extend the enforcement policies for the devices beyond the 5/11 expiration of the Covid-19 public health emergency and a 180-day period announced in a 3/13 Federal Register
Devices
FDA has cleared a GE HealthCare 510(k) for its Allia IGS Pulse imaging system. The device features a monopolar x-ray tube used to capture images for interventional procedures. “The small footprint of the new tube also helps clinicians reach steep angulation for better understanding of coronary artery anatomy,
Devices
FDA has cleared a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device. “Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is used for the diagnosis and staging of lung cancer,” the company says. “This procedure is performed by inserting a long, flexible fine needle through
Devices
Former Dolor Technologies CEO Mark Wright pleaded guilty in federal court on 10/11 to misdemeanor charges of causing the introduction of misbranded and adulterated medical devices into interstate commerce. The Justice Department says Dolor sold the SphenoCath, which was intended to treat migraine headaches by administering nerve blocks to
Devices
An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher levels of formaldehyde that rapidly decrease over one week. The update is part of the agency’s ongoing evaluation of published literature that found elevated levels of formaldehyde, cyclohexanone, and other
Devices
FDA has cleared a SentiAR 510(k) for its CommandEP, which the company says integrates existing 3D cardiac mapping systems to create a real-time 3D holographic interface that provides physicians with an interactive, 360-degree view of the patient’s specific anatomy to allow them to deliver cardiac ablation
Devices
FDA has updated its Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers, Compliance Program 7382.845 to “clarify current processes, incorporate new authorities, and update references and program contacts.” For example, the revised manual addresses Section 704(a)(4) of the FD&C Act, which was
Devices
FDA has cleared an InfoBionic 510(k) for its MoMe ARC, the company’s third-generation remote electrocardiogram monitoring device. The new device is paired with InfoBionic’s new Bluetooth diagnostic six-lead sensor that the company says is designed to help physicians diagnose arrhythmias in patients with a demonstrated
Devices
FDA has cleared a Heidelberg Engineering 510(k) for its ANTERION platform, which the company says is designed to transform anterior segment diagnostics and streamline eye care practice workflow. “As an all-in-one upgradeable platform, ANTERION combines biometry, IOL [intraocular lens] power calculation with corneal topography and tomography, anterior
Devices
FDA has created a new committee to advise the agency on issues related to digital health technologies (DHTs), providing relevant expertise and perspective to help improve FDA’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs. An online announcement says the Digital Health Technologies
Devices
A 9/15 FDA update to its guidance on breakthrough medical devices says the agency may consider a device’s ability to improve health and healthcare disparities when deciding whether to award a breakthrough medical device designation. Writing in an online post, attorneys Thomas Greeson and Sung Park (Reed Smith)
Devices
[Commentary by Jim Dickinson] The recent exposure on this Web site of FDA 510(k) review corruption where favored companies’ devices get fast tracks to market while their competitors are slow-tracked or denied is testament to the need for an FDA definition of “substantial equivalence.” Since the term is
Devices
FDA has cleared a DePuy Synthes 510(k) for the TriLEAP Lower Extremity Anatomic Plating System, a modular, procedure-specific device for use in orthopedic foot and ankle surgery. The device includes contoured and conventional plates that can accommodate multiple screw diameters, and instruments that can be used during the
Devices
A 3/1-4/13 FDA inspection at Abiomed in Danvers, MA, identified multiple violations in the firm’s manufacturing of several Impella pump Class 3 medical devices. A just-released 9/19 Warning Letter says the inspection found that the Impella Connect System device is adulterated because the company