Devices
FDA has cleared a HeartVista 510(k) to provide its artificial intelligence-assisted One Click MRI acquisition software on Siemens Healthineers MRI scanners. The company says the software includes scan accuracy enhancements, real-time automated analysis of regional wall motion as part of a cardiac function assessment, registration of perfusion
Devices
Aligned Medical Solutions has recalled its custom convenience kits due to the potential for the plunger on the Cardinal Health Monoject Flush Prefilled Syringe (0.9% sodium chloride) to draw back after the air has been expelled and reintroduce air back into the syringe. “If a clinician is not aware
Devices
FDA has granted Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for the qualitative detection of the Covid-19 virus. The company says the test can return a positive result as soon as 47 minutes using nasopharyngeal, oropharyngeal, anterior nasal, and
Devices
Medical device regulatory consultant Adrienne Lenz (Hyman, Phelps & McNamara) says FDA needs to catch up with technology so that 510(k) submissions created with the eSTAR (electronic submission template and resource) template can be submitted to the agency electronically. Writing in her firm’s FDA Law Blog, Lenz says
Devices
Florida medical device company Arthrex has agreed to pay $16 million to resolve a whistleblower’s False Claims Act allegations that its payment of kickbacks to a Colorado orthopedic surgeon resulted in the submission of false Medicare claims. A Department of Justice statement says the settlement resolves allegations that the
Drugs
The Consumer Healthcare Products Association (CHPA) says there are several steps FDA should take as it implements the DC Court of Appeals decision in Genus Medical Technologies. The court determined that FDA cannot regulate as a drug any product that meets the definition of a medical device in section 201(
Devices
New research has uncovered numerous software vulnerabilities in medical devices. The new vulnerabilities are found in software called Nucleus and could allow remote code execution, denial of service, and information leaks, according to researchers at Forescout Research Labs. Nucleus is used in safety-critical devices, such as anesthesia machines, patient
Devices
FDA has cleared a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation (TMS) device designed for the clinical setting. The company says the device offers enhanced workflows with navigated TMS and analytics. It also features Magstim Connect, a patient data management system for TMS that is
Devices
FDA has granted ReWalk Robotics a breakthrough device designation for its ReBoot, a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke. The device is a customizable and personalized for home and community use, according
Devices
FDA says it has uploaded a video, Cyber Vitals: Information for Patients’ Medical Device Health, with practical steps patients can take to protect their device and personal information. An agency statement (contains link to video) says as medical devices are more connected, devices may be exposed to cybersecurity risks. “FDA
Devices
FDA has cleared a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter. “When inflated, the Flume balloon envelops the tip of the catheter so that the emptying bladder makes contact with the flexible balloon surface rather than the rigid catheter tip,” the company says. “The drainage ports
Devices
Increasing the availability of over-the-counter (OTC) Covid-19 home tests is a top priority at FDA, according to acting commissioner Janet Woodcock. In 11/4 testimony provided to the Senate Health Education Labor & Pension Committee, Woodcock said the agency prioritizes the review of emergency use authorization (EUA)
Devices
FDA has published a draft guidance, Content of Premarket Submissions for Device Software Functions, with information on the recommended documentation sponsors should include in premarket submissions for the agency’s evaluation of the safety and effectiveness of medical device software functions. When final, the document will replace a 5/11/
Devices
FDA has approved Insightec’s Exablate Neuro for treating advanced Parkinson’s disease patients suffering from mobility, rigidity, or dyskinesia symptoms. The company says the Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus during a pallidotomy. Insightec says the treatment is incision-less, does
Devices
FDA has designated TecTraum’s Pro2cool System as a breakthrough device. The company says Pro2cool is a “novel, non-invasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their pre-injury baseline sooner. The device provides localized cooling for the head
Devices
A 6/16-7/8 FDA inspection at CellEra, a Monroe, OH, specification developer and own-label distributor of various sterile wound dressings with drug, identified nine Quality System Regulation violations, including seven repeat violations from an earlier inspection. A 10/20 Warning Letter says the specific violations were: * failing
Devices
FDA has granted breakthrough device designation to Renew Bioscience’s Cerezen device, described as a novel treatment for mild cognitive impairment due to Alzheimer’s disease and mild dementia of the Alzheimer’s type. The company says the device is a drug-free, non-invasive technology designed to improve cerebral
Devices
Datascope/Getinge/Maquet is recalling its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump (IABP) battery packs due to a battery failure risk. Substandard batteries can shorten run-time, which may cause the device to stop working when operated by battery only, a recall notice says. “If a patient requires life-
Devices
Zimmer Biomet has recalled its Rosa One 3.1 Brain Application, a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery, due to a software error. The device comprises a compact robotic arm and a touch screen mounted on a stand. Different types of instruments or
Devices
FDA has cleared a NeuroLogica 510(k) for its Auto Lung Nodule Detection (ALND) tool, a computer-assisted detection solution for detecting pulmonary nodules from 10 to 30mm in size through an artificial intelligence algorithm. It is designed to aid physicians in reviewing adult posteroanterior chest radiographs, the company says.
Devices
Two Morrison Foerster attorneys say an FDA 10/14 virtual public workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML (artificial intelligence/machine learning) technology in the medical device space, with an emphasis on information-sharing methods for patients, caregivers, and providers.
Drugs
The Covid-19 pandemic forced FDA to take a much closer look at the use of real-world data and it will likely play a bigger role in agency drug reviews as it adopts lessons learned from the pandemic. That’s the view in a 10/26 Bloomberg Law report.