Devices
Three Hyman, Phelps & McNamara attorneys say FDA was irresponsible in not providing specific evidence to support claims in a 4/19 safety warning about non-invasive prenatal tests (NIPT). Writing in their firm’s FDA Law Blog, the three say the agency safety warning told patients and healthcare providers
Devices
FDA has granted de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast cancer patient blood for subsequent analysis. “This FDA regulatory clearance is the culmination of a sustained effort by the company for over six years including extensive dialog and
Devices
FDA has cleared an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use during cardiac ablation, such as ventricular tachycardia (VT). The device is intended to address many of the challenges of conventional VT
Devices
FDA has cleared a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism. The artificial intelligence-based clinical decision support tool is designed to automatically identifies and sends notifications of suspected central pulmonary embolisms on computed tomography pulmonary angiogram images, the
Devices
The Consumer Healthcare Products Association (CHPA) says it supports FDA efforts to harmonize its current medical device Quality System Regulation with international quality management system requirements. In a comment letter, CHPA says it generally agrees with the proposed rule’s approach of incorporating ISO 13485. However, it recommends that FDA
Devices
FDA says CorneaGen recalled 1/11 one lot of scleral patch grafts that were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT and were shipped before being medically cleared. An agency notice says the 1/11 recall instructed customers to
Devices
FDA has granted NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity. The authorization was supported by data from a randomized, sham-controlled trial in 119 subjects with fibromyalgia. “In a pre-specified subgroup analysis
Devices
FDA has issued a warning about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests. The tests provide information about the possibility of a fetus having certain genetic abnormalities that could result in a child being born with a serious health condition, an FDA release says,
Devices
FDA has announced a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” FDA says the new version is intended to “further emphasize the importance of ensuring that devices are designed securely,
Devices
CDRH has announced a new “510(k) Sterility Change Master File Pilot Program” that is intended to give interested companies that terminally sterilize single-use devices (sterilization providers) using certain sterilization methods a pathway to submit a master file for the Center’s review. “FDA will accept a master file
Devices
FDA has published an update to its 6/2021 safety communication about the Philips Respironics recalled ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. The update gives the latest information about Medical Device Reports associated with the breakdown of the polyester-based polyurethane foam
Devices
The International Society for Pharmaceutical Engineering (ISPE) says FDA should provide an implementation time of at least three years for a revised medical device Quality Management System regulation. In its comment letter, ISPE also says FDA should state that any standards referenced refer to the current FDA recognized version of
Devices
Former FDA Digital Health Center of Excellence director Bakul Patel has joined Google Health and its parent company Alphabet as senior director for global health strategy and regulatory. In an online post, Patel says he is “looking forward to learning from the teams in health across Google and Alphabet and
Devices
FDA says the 4/9 Woodside Acquisitions recall of Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that have not been authorized, cleared, or approved by the agency is Class 1. An FDA notice says the recall covers
Devices
FDA has cleared a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System. The device features manual surgical instruments adaptable for use with third-party navigation systems, which are designed to assist surgeons in locating anatomical structures for pedicle screw preparation and placement, the company says. It
Devices
FDA has cleared an Oryx Dental 510(k) for its imaging product, Oryx Imaging. The medical device software provides health professionals the ability to acquire, view, annotate, and organize dental radiographs and color images, according to the company, which adds that it integrates with most dental imaging devices, such as
Devices
FDA has cleared a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System. The device features manual surgical instruments adaptable for use with third-party navigation systems, which are designed to assist surgeons in locating anatomical structures for pedicle screw preparation and placement, the company says. It
Devices
The federal government is suing The Prometheus Group, a New Hampshire manufacturer of pelvic muscle therapeutic systems and related rectal probes, and its president and sole owner Richard Poore, for violating the False Claims Act by causing healthcare providers to bill Medicare for services in which the providers improperly re-
Drugs
The National Academies of Science, Engineering, and Medicine has published Improving Representation in Clinical Trials, with recommendations for building research equity for women and underrepresented groups. The report (free PDF or purchase) says there is no doubt that past investments in clinical research to improve the health and well-being
Devices
Avanos Medical has recalled (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenteric or nasogastric tubes have been misplaced. The device is intended to help with the placement of such tubes, but if a nasogastric or nasoenteric tube is inserted incorrectly,
Devices
FDA 5/16 issued an Emergency Use Authorization (EUA) for the Labcorp’s Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test. It is the first Covid-19 direct-to-consumer test that also detects and differentiates influenza A
Devices
FDA has cleared a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platform. The first test available on the new BD COR system is the BD CTGCTV2 molecular assay, a single test that detects the three most prevalent non-viral sexually transmitted infections