Devices
FDA investigators found issues with record keeping and quality control for animals at a California animal research facility operated by Elon Musk’s Neuralink. Reuters reports the issues were found less than a month after the agency cleared Neuralink to begin testing its brain implant in humans. Based on agency
Devices
FDA has issued a safety alert on a higher-than-expected risk of device failure with DT MedTech’s Hintermann Series H3 Total Ankle Replacement (TAR) system. The agency says it is evaluating interim post-approval study (PAS) results on the device and other real-world data. “For patients with
Devices
Stakeholders are expressing concerns about an FDA 11/30/2023 proposed rule on medical device wound products. The DuVal & Associates law firm says the proposed rule “imposes requirements on wound product clearances/approvals to address an unsubstantiated concern. The proposed rule addresses the issue of antimicrobial resistance and its
Devices
FDA has cleared a Nevro 510(k) for its Nevro1 sacroiliac (SI) joint fusion device for treating chronic SI joint pain. The company says the device is proven to “immediately transfix the SI joint to allow the opportunity for long-term fusion. Self-contained, deployable titanium anchors transfix the sacrum
Devices
Medtronic Neurology has recalled (Class 1) its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume, due to the potential for catheter disconnection from patient line stopcock connectors. An FDA recall notice notes that the cause of the
Devices
An FDA safety alert is warning patients and healthcare providers about the potential risk of serious complications with Holigic’s BioZorb Marker and BioZorb LP Marker devices, which are implanted in soft tissue (e.g., breast tissue) where the site needs to be marked for future medical procedures, such as
Devices
Vyaire Medical has recalled (Class 1) its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used in manufacturing. An FDA recall notice says the device presents a risk of hypoventilation “caused by duckbill and ring broken/disassembled… Device failure may cause improper ventilation or
Devices
FDA has cleared a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury. The immunoassay is intended for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. “Determination of NGAL is intended to be used in conjunction with
Drugs
Hogan Lovells attorneys Lowell Zeta and Blake Wilson say actions that FDA will and will not take this year will vary in part because this is a presidential election year. Zeta and Wilson were joined by Greenleaf Health executive vice president for regulatory compliance Kalah Auchicloss and executive vice president
Devices
FDA has granted Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy (CBT) platform that is intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). The designation is based on data from the company’s LivVita clinical study, which met its primary endpoint by reducing liver fat
Devices
FDA has cleared a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling. “The ClearPoint system can now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene
Devices
FDA has cleared a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery. The device is intended to give surgeons the flexibility to complete a total shoulder replacement using anatomic or reverse techniques and to “enable precise placement for improved outcomes,” the company says.
Devices
The Medical Device Manufacturers Association (MDMA) says it is concerned that some aspects of an FDA draft guidance on using real-world evidence (RWE) to support regulatory decision-making for medical devices “place overly restrictive burdens on the use of RWE and real-world data (RWD) are not consistent with
Devices
CDRH director Jeffrey Shuren says more companies should be joining FDA’s Total Product Lifestyle Advisory Program (TAP) which is intended to help reduce the risk in the development process for new medical devices. Speaking 2/20 at the AAMI/FDA neXus device standards conference, Shuren said feedback on the
Drugs
The three top Democrats on the House Energy and Commerce Committee are urging FDA commissioner Robert Califf to quickly issue a congressionally mandated guidance on clinical trial diversity action plans that was due on 12/29/2023. In their 2/20 letter, Reps. Frank Pallone (D-NJ), Anna Eshoo (D-
Devices
FDA has posted a Medtronic customer letter with updated information for use, new training material, and unique device identifier information for its NIM CONTACT Reinforced EMG (electromyogram) Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube. The post says the updates include information on what to do when airway obstruction
Devices
FDA is reminding sponsors of medical device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently evaluate all testing results before submitting them to the agency. A 2/20 online post says that in recent years FDA has observed
Drugs
Two policy executives with the Coalition for a Prosperous America say there are steps FDA, Congress, and other federal agencies could take to reduce drug shortages and the threat of medical device shortages. In a deeply-researched article in American Affairs, Nick Iacovella and Jon Toomey lay much of the
Devices
FDA has cleared an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for electrophysiological monitoring. The device comprises customizable dry-printed multi-modal electrode patches that are intended to monitor a range of biopotential signals from anywhere on the body to acquire EEG
Devices
After serving 14 years at FDA, CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel is set to retire this spring, according to an agency email to MedTech Dive. OPEQ is responsible for the program areas for approving and clearing medical devices, such as 510(k)s, PMAs,
Drugs
FDA is several weeks late in issuing a guidance on how and when drug and medical device companies must submit diversity action plans for clinical trial research, according to a Regulatory Affairs Professionals Society (RAPS) Regulatory Focus online post. The December 2022 Food and Drug Omnibus Reform Act requires manufacturers
Devices
FDA has cleared a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System. The device supports implantation of up to four different reflector configurations, according to the company. “When implanted within abnormal breast or other soft tissue, the reflectors are designed to pinpoint tumor location in multiple