Devices
FDA has cleared an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical procedures. The device features a single user interface to control functions from a single input and output graphical display screen, according to the company. It is a fully
Devices
As Philips negotiates a consent decree with the Department of Justice (DoJ) acting for FDA over GMP issues with its troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines (see earlier story) , DoJ 9/1 says the company has agreed to
Devices
FDA says the 6/22 Integra recall of 388 CereLink ICP monitors is Class 1. An agency notice says the affected intracranial pressure monitors were distributed in the U.S. between 6/1/21 and 5/31/22. Integra recalled the units after reports that they may display incorrect values
Devices
FDA has given 510(k) clearance to Viz.ai for its automated RV/LV ratio algorithm, part of the Viz PE (pulmonary embolism) solution. The company says the algorithm is designed to quickly and accurately measure the diameter of the ventricles of the heart to provide the ratio of the
Devices
Novo Nordisk has agreed to pay $6.3 million to resolve allegations that it violated the False Claims Act by selling its NovoFine 30G 8 mm and 32G 6 mm needles to U.S. government agencies and because they were manufactured in non-designated countries in violation of the Trade
Devices
FDA has cleared a Baxter International 510(k) clearance of its new Novum IQ syringe infusion pump (SYR) with Dose IQ Safety Software. The device’s user interface features colored visual banners that clearly identify enteral delivery, a backlit keypad and guided syringe loading, Baxter says. It also has the
Devices
Medical device cybersecurity consulting firm MedCrypt has hired former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Schwartz as the firm’s new senior director of cybersecurity quality and safety. With six years of device review experience at CDRH and over 20 years of systems engineering experience, Schwartz at MedCrypt
Devices
FDA has cleared a BrainsWay 510(k) for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and depression, including those with comorbid anxiety symptoms (anxious depression). The clearance was based on data from a randomized, double-blind, controlled multicenter trial in 144 subjects.
Devices
Researchers from the Medical Device Innovation Consortium (MDIC), including an FDA representative, have produced a paper and framework to give clinical trial researchers and teams an opportunity to incorporate lessons learned from case studies on the use of patient preference information (PPI) into their clinical development programs. “As the body
Devices
Hamilton Medical has recalled its Hamilton-C6 Intensive Care Ventilator after customer complaints were received about a hardware issue with the ventilator’s status indicator board. “The status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board,” a recall
Devices
Intera Oncology has recalled its Intera 3000 Hepatic Artery Infusion Pump after receiving three reports that the pumps were delivering medications (flow rate) faster than expected. “If the pump delivers infusions at faster than expected flow rates, the patient may receive too much medication at one time, resulting in life-
Devices
FDA has issued a safety alert about Philips Respironics recalling certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. “If that plastic is in the device motor, it may release certain chemicals of
Devices
FDA has removed N95 respirators from its medical device shortage list, which it says signals that “demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. This action is the result of increased domestic manufacturing of N95 respirators,
Devices
Integra LifeSciences has begun a global product removal of all CereLink intracranial pressure monitors as a result of customer reports about The devices recording out-of-range pressure readings. The company believes that the out-of-range readings are caused by electrical interference from the external environment and/or interference
Devices
FDA says the Medtronic 6/28 recall of 23,372 HeartWare Ventricular Assist Device (HVAD) batteries for electrical faults that cause battery failure is Class 1. An agency notice says the batteries were distributed from 1/1/09 to the present. The notice says batteries with an electrical fault may
Devices
FDA has approved Abbott’s Proclaim Plus spinal cord stimulation system that the company says builds on its proprietary BurstDR stimulation. A company statement says the system features FlexBurst360 therapy that offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can
Devices
FDA has cleared a Surgalign Holdings 510(k) for its Cortera Spinal Fixation System. The device features a 5.5/6.0mm rod pedicle screw system that “maintains a comparatively low profile and a newly designed locking mechanism,” according to the company. Surgalign says the Cortera system will be integrated
Devices
FDA has updated its Web page listing enhancements to CDRH’s Electronic Medical Device Reporting (eMDR) system. The page says the agency recognizes the importance of providing early notice and predictability about potential eMDR system changes. It is adopting a yearly schedule for announcing and implementing enhancements to the eMDR
Devices
The Medical Device Information Consortium (MDIC) has launched its somatic reference samples (SRS) initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next-generation sequencing (NGS). An MDIC release says the group is collaborating with FDA, the National Institute of Standards
Devices
Essilor International (Dallas, TX) has agreed to pay $16.4 million to resolve allegations that it violated the False Claims Act by paying eye care providers to order and purchase its optical lenses and equipment used to produce optical lenses. “The anti‑kickback statute prohibits offering or paying anything of
Devices
FDA has issued a safety alert on autoinjector devices that are optional for use with multiple sclerosis therapy glatiramer acetate injection drug products due to incompatibility issues. According to the agency, there are currently three FDA-approved glatiramer acetate injection drug products on the market — all available in a single-
Devices
FDA has cleared a Koag 510(k) for its Vascette HP device, a topical vascular closure pad that uses a proprietary, plant-derived hemostatic foam. The device provides rapid hemostasis after cardiac catheterization without direct compression over the arterial puncture site (arteriotomy), according to the company. It is designed for