Devices
FDA is co-sponsoring with the Digital Medicine Society a 6/26-27 public workshop entitled “Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle.” The workshop is intended to illustrate how patient-generated health data (PGHD) can promote medical
Devices
Philips Respironics has recalled (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy in case of a ventilator inoperative alarm. An interruption/loss of therapy could lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death, a recall
Devices
Members of the FDA Molecular and Genetics Panel of the Medical Devices Advisory Panel have recommended the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. “The advisory committee’
Biologics
Responding to a question posed during a 5/23 hearing held by the House Energy and Commerce Committee Health Subcommittee, CDER director Patrizia Cavazzoni said FDA would benefit from having the authority to order mandatory recall of harmful drugs. “We have that authority for lettuce, but not for drugs,” she
Devices
FDA has approved a CorTec IDE to allow the University of Washington School of Medicine to conduct a study involving the closed-loop Brain Interchange Implant System. The study will investigate a “novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain,” the company says. The study
Devices
Members of the FDA Molecular and Genetics Panel of the Medical Devices Advisory Panel will be asked to vote 5/23 on the safety and effectiveness of the Guardant Health Shield blood-based colorectal cancer screening test. An agency executive summary distributed in advance of the meeting says Shield is
Devices
Commenting on an FDA virtual public workshop about expanding the Accreditation Scheme for Conformity Assessment (ASCA), AdvaMed says it believes there is significant promise in the program and has suggestions intended to help ASCA achieve its promise now that the pilot is a permanent program. In its letter, the association
Devices
FDA says the Hologic 3/13 recall (correction, not product removal) of nine BioZorb markers due to complications and adverse effects with implanted devices is Class 1. An agency notice says the 53,492 devices recalled in the U.S. were distributed between 4/29/2019 and 4/1/2024.
Devices
Sen. Rand Paul (R-KY) and Rep. Brad Finstad (R-MN) have introduced resolutions in the Senate and House under the Congressional Review Act to repeal an FDA rule that asserts the agency’s authority to oversee laboratory-developed tests (LDTs). In a statement, Paul says the FDA rule “seeks
Devices
The Medical Device Manufacturers Association (MDMA) has several suggested changes for an FDA draft guidance on select updates for the premarket cybersecurity guidance. MDMA says that while the draft says that upon finalization it will supersede an existing guidance, MDMA recommends that the new content and concepts in the draft
Devices
FDA has cleared a Meditrina 510(k) for its second generation bipolar radiofrequency Aveta Glo hysteroscopy system. “The Aveta System 2.0 builds on the success of its first-generation system, introduced in 2019, allowing physicians full control of procedures from the hysteroscope handle with integrated resection and fluid management,
Devices
The Advanced Medical Technology Association (AdvaMed) says FDA’s new draft guidance on “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" needs to explore ways of better promoting efficient and appropriate use of the program in response to increasing usage. The Q-Sub program
Devices
FDA has granted Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia. The company says it is seeking marketing authorization for the laboratory-developed test because “improved diagnostic tests are
Devices
CDRH has qualified the Assessment of IntraOcular Lens Implant Symptoms instrument as a new medical device development tool. An online statement says the patient-reported outcome instrument is used after patients receive bilateral intraocular lens implants and (1) can help quantify and provide patients and clinicians with information about visual
Devices
FDA is updating a Draeger Class 1 recall (device correction) of the Perseus A500 anesthesia workstation after receiving reports that the internal backup battery failed spontaneously while the system was being operated off the main power supply. “The battery failure caused unexpected shutdown without a low battery alarm while the
Drugs
Drug recall events dropped 14.5% in the first quarter of 2024 below the fourth quarter of 2023, according to the Sedgwick Recall Index for the first quarter. The index shows that failed specifications were the leading cause, affecting 23.2% of the 112 recalls. The total affected units fell
Devices
FDA said on 5/16 it has imposed an Import Alert for Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co. to prevent plastic syringes made by the two China-based manufacturers from entering the U.S. The agency has been monitoring concerns about some Chinese plastic syringes
Devices
FDA has approved Roche’s human papillomavirus (HPV) self-collection solution, which the company says is one of the first available in the U.S. A company statement says the solution will expand access and screening options to help eliminate cervical cancer. “In a healthcare setting,” the statement says, “an
Devices
FDA has cleared an Atraverse Medical 510(k) for its Hotwire radiofrequency (RF) guidewire, a device that enables zero exchange left-heart access while also acting as a rail for catheter-based therapy systems. The device, featuring universal sheath compatibility and “optimized RF technology,” is intended to “improve patient outcomes
Devices
Abbott is recalling (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. “In all reported events, the issue was observed during implantation of the device,” a recall
Devices
FDA has cleared an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that Indica says enables slides to be reviewed from any location the moment they are scanned, allowing pathologists to diagnose cases remotely without waiting on the physical transfer of slides. The clearance allows HALO
Devices
FDA says CTK Biotech’s ImmuView Covid-19 Antigen Home Test that is FDA authorized under an emergency use authorization now has a longer shelf life than previously authorized. “The expiration dates for these tests have been extended to reflect the longer shelf-life,” an agency notice says. The expiry