Devices
FDA has granted Cosmo Artificial Intelligence a de novo marketing authorization for the GI Genius, the first device that uses artificial intelligence based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy. The authorization was
Devices
FDA has cleared an Activ Surgical 510(k) for the ActivSight Intraoperative Imaging Module for enhanced surgical visualization. The module has been designed to provide surgeons real-time intraoperative visual data and imaging not currently available through existing technologies, the company says. The imaging module will also power the company’
Devices
A New Jersey federal court has reiterated that plaintiffs challenging the safety or effectiveness of Class 3 medical devices with premarket approval can’t rely on the res ipsa loquitur (occurrence of an accident implies negligence) doctrine to satisfy their pleading obligations. Attorney Andrew Tauber (Winston & Strawn) writes in
Devices
CDRH posted on 4/6 two new training modules for the Medical Device Single Audit Program. The first covers the measurement analysis and improvement process under the MDSAP. The presentation says that the purpose of an organization’s measurement, analysis, and improvement process is to collect and analyze information, identify
Devices
A majority of the members of the FDA Circulatory Systems Device Advisory Panel has voted to support FDA PMA approval of the TransMedics OCS heart system for donor hearts currently utilized and unutilized for transplantation. The panel voted 12-5-1 that the benefits of the system outweigh its risks,
Devices
FDA has approved Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery. OVDs aid in cataract extraction and intraocular lens (IOL) implantation by creating and maintaining space, aiding in tissue manipulation, enhancing visualization, and protecting the corneal endothelium and other intraocular tissues, the company says.
Devices
The 9th Circuit Court of Appeals has affirmed in part and reversed in part a California federal court’s decision dismissing a whistleblower’s False Claims Act suit alleging that Medtronic fraudulently obtained FDA clearance for several medical devices used in spinal fusion surgeries, unlawfully marketed the devices for off-
Devices
FDA has approved a NuVasive PMA for its Simplify Cervical Artificial Disc for two-level total disc replacement. Approval was based on data that demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level IDE study, the company says. In the study,
Devices
FDA has cleared a Surgical Information Sciences 510(k) for an updated algorithm with new visualization capabilities for its SIS System. The device was previously cleared for visualizing brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a deep brain stimulation (DBS) procedure, and
Devices
FDA has cleared an Orthofix Medical 510(k) for its 3D-printed Construx Mini Ti Spacer System for use in enhancing anterior cervical discectomy and fusion (ACDF) procedures. ACDF procedures, which are often used to treat a herniated cervical disc or degenerative disc disease, involve replacing a patient’s damaged
Devices
The Medical Device Innovation Consortium, of which FDA is a member, has released a new report entitled Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The report examines opportunities that exist for patient input to help define unmet need, clarify patient preferences, develop endpoints that
Devices
FDA has granted Empirical Spine a breakthrough device designation for its LimiFlex Paraspinous Tension Band and its use in spinal surgery. Key potential benefits cited in the company’s breakthrough request include “shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospitalization length of stay, and improved
Devices
Allarity Therapeutics has submitted a PMA for DRP-Dovitinib, the company's validated companion diagnostic for Novartis’ dovitinib that is intended to be used to identify patients suffering from renal cell carcinoma. Allarity is licensing the drug from Novartis and plans to submit an NDA later this year. The
Devices
FDA says it wants to be sure that healthcare providers, including those who work in healthcare facility reprocessing units, are aware of the risk of infections associated with reprocessed urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes. A 4/1 letter to healthcare providers says the agency has received numerous medical
Devices
FDA has granted Abbott an Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNow Covid-19 Ag Self Test for detecting Covid-19 infection. The new indication allows individuals with or without symptoms to be tested without a prescription. According to the company, the test
Devices
FDA says the Medical Device Innovation Consortium is seeking medical device manufacturers to participate in an Accelerate Sustainable Capability (ASC) pilot study that was developed in collaboration with the medical device industry, Information Systems Audit and Control Association, and FDA. An agency notice says the pilot study is intended to
Devices
CDRH director Jeffrey Shuren says the FDA Medical Device Development Tools (MDDT) program is a way for the agency to qualify tools that medical device developers can use in the development and evaluation of medical devices. Writing in an online FDA Voices post, Shuren says qualification means the agency has
Devices
An FDA safety communication is cautioning patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction have a higher chance of complications or problems. The online communication says the agency has not cleared or approved ADM or mesh for use in breast
Devices
The leader of a Facebook group involving patients injured by LASIK eye correction procedures is urging FDA acting commissioner Janet Woodcock to crack down on false and misleading advertising by LASIK providers. Paula Cofer, who founded the 7,400-member LASIK Complications Facebook Group in 2014 to give a voice
Devices
FDA has cleared a Nines 510(k) for the NinesMeasure, a lung nodule measurement tool built with artificial intelligence that is intended to accelerate diagnoses of certain respiratory diseases. The company says the device enables radiologists to quickly measure the long and short axes of selected nodules with a high
Drugs
A 9/9-9/27/19 FDA inspection at Tarmac Products, Miami Gardens, FL, found multiple violations in the firm’s manufacturing of over-the-counter drug products and wound dressing medical devices. A just-released 11/9/20 Warning Letter lists violations of current good manufacturing practice (CGMP) regulations
Devices
FDA has posted a new Web page for clinical laboratory staff and healthcare providers on the impact of viral mutations on Covid-19 molecular, antigen, and serology tests. The agency says it will update the page as significant new information become available. The new Web page includes background on SARS-