Devices
FDA has cleared a Neuronetics 510(k) for its NeuroStar Advanced Therapy for use as an adjunct for treating major depressive disorder in adolescent patients aged 15-21 years. The company says NeuroStar is the first transcranial magnetic stimulation treatment FDA-cleared for this age group, making it the fourth
Devices
FDA has approved the Medtronic Evolut FX+ transcatheter aortic valve replacement system to treat symptomatic severe aortic stenosis. The company says the latest Evolut system maintains the valve performance benefits of the legacy platform and is designed to facilitate coronary access. Medtronic says it expects a full product launch in
Devices
Attorneys Jeffrey Gibbs (Hyman, Phelps & McNamara) and Christian Stephens (Eckert, Seamans, Cherin & Mellott) say FDA has failed to follow the science in its lengthy battle to prevent the Judge Rotenberg Educational Center (JRC) in Canton, MA, from using an electrical stimulation device (ESD or electroshock) to treat patients
Devices
A 5/15-5/18/2023 FDA inspection at ReNovo, doing business as Provision Device Reprocessing Solutions in Bend, OR, found Quality System Regulation and other violations in the firm’s reprocessing and distribution of several single-use medical devices. A just-released 10/13/2023 Warning Letter says the
Devices
Rep. Earl Blumenauer (D-OR) is asking FDA why it did not inspect Elon Musk’s Neuralink facility before approving human trials of its medical device, a brain-computer interface. Reuters reports Blumenauer said he was concerned that the agency ignored “troubling evidence” of animal testing violations that had been
Devices
Medline Industries is recalling (Class 1) certain kits, trays and packs in direct response to Nurse Assist’s 11/2023 recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to sterility concerns. The kits contain Nurse Assist saline solution that was previously recalled due
Devices
FDA is again proposing to ban electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The agency has determined that this rare regulatory move is necessary because the devices present an unreasonable and substantial risk of illness or injury. FDA issued a final rule in 2020
Devices
Teleflex/Arrow International is recalling (Class 1) the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to reports about a potentially defective component. “The complaints received relate to resistance of the guidewire handle/chamber during use,” a recall notice says. “The possible immediate health consequences of the
Devices
AdvaMed has given FDA 44 proposed edits to the agency’s draft guidance on the characterization of metallic coatings and/or calcium phosphate coatings on orthopedic devices. The association’s specific line-by-line suggestions are displayed in a 14-page table.
Devices
Vyaire Medical is recalling (Class 1) certain AirLife Manual Resuscitators due to a manufacturing defect. “Using the recalled resuscitators could result in patients not receiving enough ventilation,” a recall notice says. “In some cases, patients may not receive any ventilation. People who don’t get adequate ventilation may not be
Devices
House Energy and Commerce Health Subcommittee chair Brett Guthrie (R-KY) told a 3/21 hearing that he cannot support FDA’s proposed rule on oversight of laboratory-developed tests (LDTs) and said it should be withdrawn while legislative proposals are crafted to address outstanding challenges with such devices. “As
Devices
FDA has granted Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The company says DynamX is the only metallic device “designed to support the
Devices
The FDA Ophthalmic Devices Panel will discuss on 3/21 the de novo request from Balance Ophthalmics, Inc., for its FSYX Ocular Pressure Adjusting Pump. An agency briefing document released before the meeting says the device has a set of goggles connected to a pump. When the goggles are worn,
Devices
FDA has cleared a Fujifilm Healthcare Americas 510(k) for CAD EYE, an artificial intelligence detection system for endoscopic imaging. The device provides real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures, supporting endoscopists in their ability to detect and remove pre-cancerous lesions,
Devices
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Drugs
FDA is seeking applicants for a funding opportunity to explore the role of digital health technologies (DHTs) such as actigraphy, photography, and environmental sensors, in evaluating new drugs. An agency announcement says projects may involve engagement with researchers from academia, the biopharmaceutical industry, patient groups, and other stakeholders. The project
Devices
FDA has published a draft guidance, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling, describing relevant information that should be provided in a premarket submission to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in
Devices
FDA has published an updated draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, giving an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. The document says the interactions can include written
Devices
FDA has cleared an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that is intended to facilitate an optimal fit within the hip’s canal for a diverse range of patient anatomies. The device is designed for initial and long-term stability, and it
Devices
Johnson & Johnson’s Medos International Sarl device unit has recalled (Class 1) its Cerebase DA Guide Sheath after receiving an increase in complaints about fractures at the distal end, which may result in surgical procedural delay, vascular injury, and rare embolism events. The company recently sent an urgent medical
Devices
Sen. Bill Cassidy (R-LA), who says FDA is exceeding its legislative authority in seeking to reform clinical test regulation through rulemaking, is asking stakeholders for their ideas on how Congress can modernize current regulations to support innovation and ensure the tests are safe and effective to use. In an
Devices
Attorney Benjamin Zegarelli (Mintz) says that until Congress gives FDA new authorities to regulate software as a medical device (SaMD), the agency must get creative to keep up with rapidly evolving technology. Writing in an online post, Zegarelli says that “with the rise of artificial intelligence (AI) and machine learning