Devices
FDA has approved Intact Vascular’s Tack Endovascular System (4F), described by the company as a minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and peroneal arteries. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II Below the Knee clinical
Devices
FDA has issued an immediately-in-effect guidance to “provide a policy to help expand the availability of digital health therapeutic devices for psychiatric disorders to facilities consumer and patient use while reducing user and healthcare provider contact and potential exposure to Covid-19 during this pandemic.” The document says
Drugs
FDA has extended until 6/5 the deadline to apply for a funding opportunity to examine the use of real-world data (RWD) to generate real-world evidence (RWE) in regulatory decision-making. FDA intends to encourage innovative approaches to further explore RWD use while making sure that scientific evidence
Devices
FDA commissioner Steve Hahn says that ramping up of caronavirus testing, both diagnostic and new antibody tests, will be necessary to gradually allow people who are isolating at home to return to work. Speaking 4/12 on ABC’s “This Week With George Stephanopoulos,” Hahn contradicted president Trump’s statement
Devices
FDA has released a final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products.” The document recommends certain factors companion diagnostic developers should consider when determining whether their test could be developed, or if labeling for approved companion diagnostics could be
Devices
FDA has granted BD (Becton, Dickinson) an emergency use authorization for a molecular diagnostic test for Covid-19 that can return results in two to three hours. The test is based on the CDC assay design and is run on the BD Max System, which performs other tests from collaborations
Devices
FDA has issued an emergency use authorization to Terumo BCT and Marker Therapeutics for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices that serve as a blood purification system to treat patients with confirmed Covid-19 admitted to the intensive care unit with confirmed or imminent respiratory
Devices
FDA has issued a second emergency use authorization (EUA) for decontaminating compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The EUA was issued to Steris Corp. for the Steris V-Pro 1 Plus, maX and maX2 Low Temperature Sterilization Systems with the Steris
Devices
FDA has granted Vapotherm a breakthrough device designation for its Oxygen Assist Module for use in the company’s Precision Flow system, a mask-free alternative to nasal continuous positive airway pressure as well as noninvasive positive pressure ventilation. The module assists staff in maintaining a targeted SpO (amount of
Devices
Medtronic says FDA granted an emergency use authorization for its Puritan Bennett 560 ventilator that will soon be available in the U.S. A company statement says it expects the units, currently sold in 35 countries, to be available in the U.S. in May. Also, Medtronic says it has
Devices
Just how accurate are the Covid-19 diagnostic tests? That’s a question two House lawmakers are asking FDA to provide information on in the wake of testing failures earlier this year involving Centers for Disease Control test kits. A 4/9 letter from U.S. reps. Lloyd Doggett (D-
Devices
FDA has just released a 3/20 petition submitted by the Judge Rotenberg Educational Center, Canton, MA, asking that the agency immediately and indefinitely stay the two effective dates for its final regulation banning electrical stimulation devices used to treat self-injurious or aggressive behavior. The petition, which asked for
Devices
The Justice Department says Pentax Medical Company will pay $43 million to resolve criminal charges based on the company’s shipment of four types of endoscopes for 18 months without FDA-cleared instructions for use and the company’s failure to file timely reports of two infractions associated with its
Devices
The development of serology tests for Covid-19 detection is of “growing importance” in CDRH’s response to the ongoing coronavirus health emergency, Center Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel said during a 4/8 virtual town hall teleconference on diagnostic tests. The tests will
Drugs
A Society of Corporate Compliance and Ethics (SCCE) online white paper points to the lack of drug and medical device supply chain resiliency as a major problem in worldwide efforts to combat the novel coronavirus. “If the nations of the world all had access to accurate and swift testing, ventilators,
Devices
A 10/14-10/17/19 FDA inspection at Mandelay Kft, Tokol, Pest, Hungary, found Quality System Regulation violations in the firm’s manufacturing of the Scientific Consciousness Interface Operation system and the Quantum University Energetic System Technology 9 devices. A just-released 2/3 Warning Letter says specific violations
Devices
Boston Scientific has recalled (Class 1) its Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. The device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries.
Devices
FDA has cleared a Nitiloop 510(k) for its NovaCross CTO Microcatheter. The device is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions, prior to percutaneous transluminal coronary angioplasty or stent intervention, according to the company. It is also intended
Devices
FDA says that for the duration of the coronavirus public health emergency in the U.S. it will not object to limited modifications to the indications, functionality, hardware, and/or software of 510(k)-cleared devices for remote assessment and monitoring of ophthalmic parameters. An immediately-in-effect guidance says
Devices
As resources are prioritized to responding to coronavirus-related activities, CDRH says it has further extended its reliance on teleconferences in lieu of in-person meetings with industry scheduled through 5/31.“ We are converting each meeting to a teleconference to be held at the same date and time,” a
Devices
FDA has posted a final guidance entitled “Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The policy applies to large volume parenteral infusion pumps, syringe infusion pumps, patient-controlled analgesia infusion pumps, and ambulatory infusion pump devices, and their accessories, in
Devices
FDA has released a guidance on “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (Covid-19) Public Health Emergency (Revised).” The document outlines a revised policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95