Biologics
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an FDA Voices post, Hahn and Shah
Devices
FDA has updated its recognized consensus standards database for medical devices. New or revised recognized standards were added and standards that are no longer recognized were withdrawn. Other updates include revisions to some standards’ extent of recognition and transition periods. An FDA guidance, Appropriate Use of Voluntary Consensus Standards in
Devices
FDA has granted Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted bronchoscopy. “Our acquisitions of NeuWave Medical and Auris Health have enabled us to bring two best-in-class platforms together as we work to develop this breakthrough technology,” the company says. The NeuWave
Devices
FDA says it is reminding patients and healthcare providers about the risk associated with using deep brain stimulation devices for Parkinson’s disease. “Patients may be at risk of injury during water-related activities (such as swimming) because of the loss of coordination while using the device,” an agency notice
Devices
FDA says the next in a series of Webinars on issues involving respirators and other personal protective equipment will be held 8/4 from Noon to 1 p.m. An agency notice said FDA, the Centers for Disease Control and Prevention, the National Institute for Occupational Safety and Health, and
Drugs
FDA has approved the Roche Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect the HER2 biomarker in breast cancer and as a companion diagnostic for the company’s Herceptin (trastuzumab). The company says the assay is designed to be completed within the same day, enabling clinicians to get
Devices
FDA has cleared a Neocis 510(k) for a new Yomi edentulous indication for its robot-assisted dental surgery system. The clearance allows for a new splint attachment which broadens Yomi’s application to include full arch implant cases as well as partially edentulous cases, according to the company. Neocis
Devices
Two law professors say that FDA guidances on seeking emergency use authorizations for new Covid-19 tests contributed to the delay in rolling out tests and, because some agency actions were not supported by law, “FDA’s interference in areas Congress had not authorized the agency to regulate was an
Devices
FDA has posted a new template for commercial developers to help them develop and submit emergency use authorization requests for Covid-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab (e.g., offices or schools), and that could be available without a
Devices
Guided Therapeutics has submitted a clinical study protocol to FDA to support marketing of its LuViva Advanced Cervical Scan. According to the protocol, the company says LuViva will be studied to assess its ability to help detect a significant number of the up to 40% to 50% of cervical cancer
Devices
FDA has published a guidance, Multiple Function Device Products: Policy and Considerations, to explain the agency’s regulatory approach and policy for all multiple function device products. Specifically, the document clarifies when and how FDA intends to assess the impact of “other functions” that are not the subject of a
Devices
FDA has reissued an emergency use authorization to LabCorp for its Covid-19 RT-PCR Test to include two new indications for use — testing for people who do not have Covid-19 symptoms or who have no reason to suspect Covid-19 infection, and to allow pooled sample testing. The
Devices
FDA has cleared a Stratus Medical 510(k) for the Vesta RF Cannula for use in radiofrequency (RF) heat lesion procedures for relieving pain. The company says Vesta was developed to treat pain in clinical scenarios where its Nimbus® RF Multitined Expandable Electrode, which provides a large volume lesion for
Devices
Internet of Things (IoT) security firm Ordr says 86% of healthcare deployments had more than 10 FDA recalls against their medical IoT devices, meaning that the medical device was defective, posed a health risk, or both. The analysis was included in Ordr’s research into connected device adoption and risks,
Devices
U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) have introduced legislation that would help protect patients from counterfeit medical products that could cause serious harm. Their Safeguarding Therapeutics Act would give FDA authority to seize and destroy counterfeit medical devices and products, including vaccines and combination
Devices
FDA has approved an Abbott PMA to allow use of the company’s Patient Controller app on compatible personal Apple smartphone devices. The app allows patients living with neurological conditions, including chronic pain or movement disorders, the ability to manage therapy directly from their personal smartphone, the company says. The
Drugs
Three FDA Centers and the Federal Trade Commission say that Web sites and YouTube channels operated by Create Wellness Clinics (21st Century LaserMed Pain Institute), Garden Grove, CA, are offering products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in
Devices
FDA has cleared an Integra LifeSciences 510(k) for its Cusa Clarity Ultrasonic Surgical Aspirator System for use in neurosurgery for resection of tumors ranging from soft to firm consistencies, which includes removal of primary and secondary malignant and benign brain and spinal tumors. Cusa is an ultrasonically vibrating surgical
Devices
FDA has approved a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay. The submission includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66
Drugs
FDA says Centurion Medical Products, Williamston, MI, manufactures and distributes sterile convenience kits that have not been approved or cleared by FDA. A just-released 6/11 Warning Letter says the agency’s 8/5-8/20/19 and 11/21-11/1/19 inspections at two Centurion sites determined
Devices
FDA has approved Boston Scientific’s Watchman FLX left atrial appendage closure device, indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage. The company says the Watchman FLX is
Devices
FDA has cleared a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis. The clearance allows in vitro diagnostic (IVD) use of FullFocus with FDA-authorized Philips Ultra Fast Scanner and paves the way for IVD use of FullFocus with additional IVD