Devices
FDA wants to make the strengthening of medical device cybersecurity a top priority and will need additional legislative authorities to advance medical device safety by ensuring the agency and public have critical information about device cybersecurity. That’s the conclusion of an online MedTech Dive post based on discussions with
Devices
A 3/22-3/30 FDA inspection at Tianjin Bolang Science Technology Development Company, Tianjin Shi, China, found Quality System Regulation issues in the firm’s manufacturing of otoscopes, rigid laryngoscopes, and rigid nasopharyngoscopes. A just-released 6/17 Warning Letter says specific violations were: * failing to establish and maintain
Devices
FDA says it is working with federal partners, medical device manufacturers, and the private sector to address cybersecurity vulnerabilities in the BlackBerry QNX real-time operating system version 6.5 service pack 1 and earlier. An agency notice says the vulnerabilities may introduce risks for certain medical devices, as well
Devices
FDA has approved an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The device is intended to close the left atrial appendage (LAA), which is where blood clots can form in people suffering from
Devices
Two Boston Scientific post-market surveillance studies (522 studies) confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scientific’s transvaginal mesh for pelvic organ prolapse (POP). FDA 4/2019 ordered manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of POP to immediately stop selling
Devices
FDA has granted Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath Covid-19 RNase P Combo Kit 2.0, assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. “Both PCR-
Devices
FDA has cleared a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of harvested adipose (fat) tissue is desired. The device is intended for use in orthopedic, arthroscopic, neurosurgery, gastrointestinal, urological, general, gynecological, thoracic, laparoscopic, and plastic and reconstructive surgeries
Devices
Baxter Healthcare is recalling its Dose IQ Safety Software used with the Spectrum IQ Infusion System due to a software defect (version 9.0.x) that may lead to mismatched drug information in drug libraries created using the software. “If the software’s drug identifier does not match the drug
Drugs
The Cato Institute, a Libertarian think tank, says a case before the U.S. 1st Circuit Court of Appeals is again raising issues involving FDA’s “paradoxical stance” toward off-label use of drugs. A Cato online post says that while it is lawful for physicians to prescribe approved drugs
Devices
A CDRH report, “2018-2020 Strategic Priorities Accomplishments,” says the Center met, and in most cases exceeded, its strategic goals in the study period. The report highlights successes in four areas: * Novel Technologies: The target was for 50% of novel technology manufacturers intending to bring their devices to the U.
Devices
FDA says its review of Web sites maintained by Vivera Pharmaceuticals, Mission Viejo, CA, determined that the firm is marketing Covid-19 antigen test kits in the U.S. A just-released 7/26 Warning Letter says the tests are offered for sale without marketing approval, clearance, or authorization from
Devices
FDA has cleared an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device. By clipping directly onto the Valkyrie Thoracic Fixation System, the the clip delivers screws fast and accurately for thoracic fixation, the company says. They are pre-loaded with
Devices
FDA has cleared a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat (ENT) Scope. The company says the device is designed to provide ENT surgeons with unparalleled views of the sinus anatomy to enhance their surgical experience. The scope allows ENT surgeons to access
Devices
FDA says its review of the Web site maintained by Captain’s Cloth, Laguna Niguel, CA, determined that the firm is marketing KN95 face masks manufactured by Lianyungang Manai Protective Equipment Co. Ltd. that are offered for sale in the U.S. without marketing approval, clearance, or authorization from FDA.
Devices
FDA has cleared a Surround Medical Systems 510(k) for its Portray dental imaging system, a 2D diagnostic tool that allows 3D tomosynthetic and 2D synthetic imaging as adjunctive tools for producing diagnostic dental radiographs of teeth, jaw, and other oral structures. “The Portray system deploys multiple X-ray beams
Devices
FDA says Lepu Medical Technology, Beijing, China, is selling three Covid-19 test kits without marketing approval, clearance, or authorization from FDA. A 7/29 Warning Letter says the kits are adulterated because the firm does not have approved PMAs in effect for them. The kits also are misbranded because
Drugs
Attorney Patricia Kaufman says a new FDA final rule amending the “intended use” regulations for drugs and medical devices “may come as a disappointment to those who were hoping that FDA would provide more clarity in its regulations regarding permissible activities. However, it is not surprising that FDA is rejecting
Devices
FDA has cleared a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care unit and operating room. The device is intended for use in bronchoscopy procedures such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal
Drugs
FDA’s recent “intended use” rule and accompanying FDA preamble and response to comments offer important advertising and promotion guidance for pharmaceutical and medical device industries, such as the agency clarifying that it will not determine a firm’s intent regarding off-label use based solely on its knowledge that
Devices
FDA has cleared a SpinTech 510(k) for its Stage magnetic resonance imaging software. The software provides a rapid, multi-contrast imaging method that allows scanning the brain in about five minutes, “unlocking the full potential of MRI,” the company says. It provides 16 different types of image contrasts, six
Devices
FDA has granted Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process an average of around 30 swab samples per hour. Clinical studies show the test has sensitivity of at least 80% and specificity of 98.0%, according to
Devices
FDA has classified as Class 1 a Boston Scientific recall of its Ingenio pacemakers and CRT-Ps due to the risk of incorrect transition to safety mode. Safety mode is intended to provide backup if the device is faulty, a recall notice says. “However, in safety mode, there is a