Devices
FDA has issued a safety alert on a cybersecurity risk with Medtronic’s MiniMed 600 Series Insulin Pump System (e.g., MiniMed 630G and MiniMed 670G). “There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system,” the
Devices
Roche has received FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform. The device combines three technologies — clinical chemistry, immunoassay and ion-selective electrode diagnostic testing — on a single platform. Cobus pure focuses on automating manual tasks to reduce the “hands-
Devices
FDA has cleared a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software. The software provides stereotactic guidance for placing and operating instruments or devices during planning and operation of neurological procedures using MRI scanners (biopsies, catheter and electrode insertion, including deep brain stimulation
Devices
CDRH is updating a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of its NIM Contact Reinforced EMG Endotracheal Tubes and NIM Standard Reinforced EMG Endotracheal Tubes due to the risk of airway obstructions. “If the tube obstructs
Devices
A MasterControl white paper analyzed medical device data from 2017 through 2019 to determine the most common FDA observations that lead to a form FDA-483 or Warning Letter. The paper says the most common observations involved these processes: * corrective and preventive action; * customer complaints; * purchasing controls; * medical device reporting
Devices
FDA says the Baxter Healthcare 8/9 recall of 511,728 Clearlink Basic Solution Sets with Duovent is Class 1. An agency notice says the devices, which are used as part of a system to administer drugs and solutions to patients, were recalled after increased consumer reports of leaks. The
Devices
FDA will hold a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on 11/1 to discuss “ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.” An agency notice says the committee also will discuss
Devices
FDA has cleared a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio. The tri-taper design is intended to allow a less intrusive surgical approach, which is similar to direct anterior procedures, the company says, allowing easier access
Devices
FDA has denied a 5/3/21 petition submitted by Janice Lintz, a self-described hearing loss consultant and advocate, who asked that the agency “standardize the naming of hearing aid features and develop a rating system using international ANSI standards for various hearing aid features.” The denial letter says
Devices
Medtronic has recalled (Class 1) its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes after receiving customer complaints about tube obstructions while in use in patients. “If the tube obstructs, ventilation failure can occur,” a recall notice says. "If the tube
Devices
FDA has released a draft guidance entitled “Computer Software Assurance for Production and Quality System Software.” The document describes a risk-based approach for “computer software assurance” to establish confidence in the automation used for production or quality systems, and to identify where more stringent controls may be appropriate. It
Devices
FDA has cleared a Boston Imaging 510(k) for its V7, an ultrasound system designed for use with the company’s Crystal Architecture to enhance image clarity. The V7 is also equipped with “Intelligent Assist” features to be used in both general imaging and women’s health ultrasound cases. Boston
Devices
FDA has denied a 2014 petition asking that the agency (1) require a Boxed Warning on LASIK devices concerning a high incidence of induced visual symptoms and dry eyes; and (2) send letters to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology to advise
Devices
Sklip Inc. says it has received IRB approval to clinically test its Sklip artificial intelligence (AI) skin cancer triage system with patients in home settings. The device, which has gained a breakthrough designation from FDA, is considered a “software as a medical device” tool that uses “proprietary artificial intelligence technology
Devices
FDA says it is aware of reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. An agency safety alert says the lymphomas reported are not the same as the lymphomas described in an earlier communication as breast implant-
Devices
FDA has published an immediately effective guidance, Policy for Monkeypox Tests to Address the Public Health Emergency, describing the agency’s review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests. The document also covers the FDA enforcement policies for certain diagnostic tests that are developed by and
Devices
An FDA safety alert is warning about potential clip lock malfunctions with Abbott’s MitraClip Delivery Systems. The company has issued an Urgent Medical Device Correction to inform health care providers about an increase in complaints regarding clip locking malfunctions, which have been observed before and after clip deployment. “These
Devices
Philips Respironics has recalled 17 million masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern related to magnets that connect components to hold the device in place. “The magnets can
Devices
FDA has expanded the approved labeling for Boston Scientific’s Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to the previous 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of patients with non-valvular
Devices
FDA has cleared a Magnus Medical 510(k) for the Saint Neuromodulation System for treating major depressive disorder (MDD) in adults who have failed to achieve satisfactory improvement from prior antidepressant medications. The clearance was based on data from a double-blind, randomized controlled trial that showed “79% of people
Devices
FDA has granted Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule for treating adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month. Vibrant is believed
Devices
Cue Health has submitted a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care (POC) use. The company says currently there are no flu tests on the market for home use. “Clinical study results with the Cue Flu Molecular Test were favorable,