Devices
FDA inspections at three Integra Lifesciences medical device facilities (Mansfield, MA, 3/12/2024-6/5/2024; Plainsboro, NJ, 4/9/2024-8/22/2024; and Princeton, NJ, 3/12/2024-8/22/2024) found Quality System Regulation violations in the firm’s manufacturing of neurological and neurosurgical medical devices.
Devices
A 7/30-9/24/2024 FDA inspection at Hologic in Marlborough, MA, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of Class 2 implantable radiographic markers such as its BioZorb product line. A just-released 12/18/2024 Warning Letter says specific violations
Devices
FDA has cleared an Icotec 510(K) for the use of its BlackArmor carbon fiber implants for treating de novo spinal infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondylopathies. Icotec’s implant offers “reduced artifacts from radiolucent Carbon/PEEK material,” which the company says enables
Devices
FDA has granted Spear Bio a breakthrough device designation for its pTau 217 blood test for early diagnosis of Alzheimer's disease. The company says current diagnostic methods (e.g., PET scans and lumbar puncture cerebrospinal fluid analysis) are “invasive, costly, and logistically challenging… Spear Bio's pTau
Devices
Philips and its subsidiary Braemar Manufacturing are recalling (Class 1 device correction) their Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after identifying that some electrocardiogram (ECG) events received were not properly routed. “As a result, these events were not reviewed by a cardiology technician for
Devices
FDA has posted a guidance entitled “Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.” The document provides information regarding the modular review program and outlines the procedures for submitting or reviewing a modular PMA or HDE. Unlike a traditional PMA or HDE when an applicant submits all
Devices
FDA has cleared a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion. The action clears the path for patients to “conveniently ingest the CapsoCam Plus capsule from the comfort of their homes under virtual medical supervision, representing a transformative step in enhancing patient accessibility and
Devices
FDA has cleared a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement. Traditional repair techniques often fail at the suture-tendon interface, which leads to retears that require further surgeries and longer recovery times, according to the company. Its FiberLocker system is designed to reinforce
Devices
Fresenius Kabi has recalled (Class 1) its Ivenix Infusion System and Large Volume Pump due to potential pneumatic valve failures that may cause the pump to stop an active infusion or could prevent the pump from being used. FDA has determined that the cause of the failures is related to
Devices
Johnson & Johnson says it has paused the U.S. external evaluation and all U.S. Varipulse cases while it investigates the root cause of four reported neurovascular events in the U.S. external evaluation. A company statement says that since beginning the external evaluation cases with the Varipulse platform
Devices
FDA has granted Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with reduced ejection fraction (HFrEF). The agency also approved the company’s investigational device exemption application for it to begin a pivotal trial focused on (HFrEF) patients, according to the company.
Biologics
An FDA summary report on clinical study diversity action plans for FY 2023 and FY 2024 shows that submission of the action plans to the agency is going up, even though such submissions are not yet required. The report shows that CDER received 124 plans in FY 2023 and 161
Devices
The UK-based maker of Anne’s Daye Tampons says it is pulling its CBD-coated tampons intended to relieve menstrual pain from the U.S. market following receipt of an FDA Warning Letter. The letter said the adulterated products were not approved for sale in the U.S. and
Biologics
FDA has approved a guidance, Communications from Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers, to reassure firms that if they provide communications that are consistent with the guidance’s recommendations, the agency will not consider the dissemination of such
Devices
FDA has published a draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, providing lifecycle management and marketing submission recommendations consistent with a total product lifecycle (TPLC) approach for AI-enabled devices. The document has recommendations on the contents of marketing submissions for devices that
Biologics
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for increasing the number of females in clinical trials and non-interventional studies to help ensure the generalizability of results. The document says it also has recommendations for analyzing and interpreting
Devices
FDA has released a final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” Agency regulations require device makers to notify FDA during or in advance of a public health emergency about any permanent discontinuance
Devices
FDA has cleared an Inogen 510(k) for the Simeox 200 Airway Clearance Device, which is intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions using high-frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The prescription device is for use in
Devices
A 7/22-7/25/2024 FDA inspection at Rontis Hellas SA in Larissa, Thessaloniki, Greece, found Quality System and Medical Device Reporting (MDR) regulation issues in the firm’s manufacturing of the Cronus HP PTA OTW balloon catheter. A recently-released 10/28/2024 Warning Letter says the specific
Devices
FDA has published an updated guidance, Global Unique Device Identification Database (GUDID), reflecting upcoming changes in the Global Medical Device Nomenclature field in GUDID and other minor clarifications. The document says database enhancements to improve user experience, build in better validation rules, and other changes may continue as the agency
Devices
FDA has approved Humacyte Global’s Symvess (acellular tissue engineered vessel-tyod) indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and autologous vein graft is not feasible. An agency statement says Symvess is the first
Devices
FDA says there is a potential need for early device replacement of Boston Scientific’s Accolade pacemakers. An agency safety communication says the company recalled a subset of Accolade pacemaker devices with an increased risk of permanently entering Safety Mode, which has limited functionality and has been associated with the