Drugs
The National Academies Committee on Security of America’s Medical Product Supply Chain makes seven recommendations for FDA, other government agencies, and other stakeholders to take to increase the resilience of the medical product supply chain. In a report (purchase or free PDF download) mandated by the 2020 CARES Act,
Devices
FDA has cleared a Pearl 510(k) for its Second Opinion, an artificial intelligence radiologic detection aid intended to help dentists identify numerous common dental problems, including tooth decay, calculus, and root abscesses. The device applies “computer vision” to “identify and highlight key pathologic and nonpathologic findings, including dental caries,
Devices
FDA says a cybersecurity vulnerability has been identified for the Axeda agent and desktop server used in numerous medical devices across several manufacturers. All versions of both technologies are affected, the agency says in an online notice. The Axeda agent and desktop server are Web-based technologies that allow one
Devices
A 9/6-9/14/2021 FDA inspection at Wickimed Medical Equipment Manufacturing Company, HuiZhou, China, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of Class 2 sterile single-use disposable electrodes. A just-released 1/7 Warning Letter says specific violations were: * failing
Devices
FDA has granted Merit Medical Systems a breakthrough device designation for its Embosphere Microspheres for use in genicular artery embolization (GAE) procedures. GAE is intended to reduce pain and disability caused by knee osteoarthritis by reducing blood flow to the knee and minimizing the inflammatory process. Merit Medical says its
Devices
FDA has granted DexCom a breakthrough device designation for its Dexcom real-time continuous glucose monitoring (CGM) system for use in the hospital setting. The designation is based on data from the company’s exploratory studies over the past seven years that found the device improves glucose control without any
Devices
FDA has cleared a Circa Scientific 510(k) for its S-CATH M Esophageal Temperature Probe which can be visualized on 3D cardiac mapping systems during cardiac ablation procedures. The multi-sensor probe is intended to provide high-density, edge-to-edge coverage of the esophagus, and being visualized on
Drugs
FDA has published a guidance, Initiation of Voluntary Recalls Under 21 CFD Part 7, Subpart C, to clarify agency recommendations on timely initiation of voluntary recalls and help companies to be “recall ready.” The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making
Drugs
The 837 medical device recalls in 2021 were 20.2% lower than the 10-year annual average of 1,049 recalls, according to the Sedgwick recall index for 2021. The report shows that software issues remained the top cause for recalls, accounting for 162 events (19.4%). The number of
Devices
FDA has approved Johnson & Johnson Vision Care’s Acuvue Theravision with Ketotifen, a drug-eluting contact lens with the antihistamine ketotife. Each lens contains 19 mcg ketotifen which is intended to previde relief from allergic eye itch. The daily disposable contact lenses are indicated for the prevention of ocular
Devices
FDA has cleared a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant. The device is intended to treat a variety of pathologies throughout the spine from C2-S1. It is smaller than a dime, the company says, and can be inserted
Drugs
Attorney Nick Oberheiden (Oberheiden PC) gives a step-by-step approach for responding to an FDA Warning Letter. In his online post, Oberheiden says FDA enforcement actions can have substantial ramifications, and manufacturers who receive Warning Letters must respond appropriately. “However,” he adds, “this does not necessarily mean jumping into
FDA Policy/General
Former FDA director of orphan product development Timothy Cote is petitioning the agency to “immediately and completely freeze all administrative actions on any regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership.” His 2/22 emergency petition cites the Russian invasion of Ukraine
Devices
FDA has posted a final guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes” that describes the processes available to outside stakeholders to request additional review of decisions or actions by Center employees. Such individuals can request supervisory review of an action, submit a petition or request a
Devices
Pink Concussions founder and CEO Katherine Snedaker, a social worker, is asking FDA to revoke the 510(k) clearance indication for use for the SyncThink Eye-Sync as an aid in diagnosing concussion. A 2/26 petition says the Eye-Sync product does not provide any addition to sensitivity or
Drugs
Attorney and data scientist Bradley Thompson (Epstein Becker Green) says that although four years ago then-FDA commissioner Scott Gottlieb promised that the agency would release the identifier number (known as the NCT number) assigned by the National Institutes of Health to clinical trials listed online at clinicaltrials.gov, it
Devices
FDA has issued three safety alerts to warn people not to use three Covid-19 tests because the agency is concerned they could generate false results. Details on the alerts are here: * FDA safety communication about the Celltrion DiaTrust Covid-19 Ag Rapid Test. * FDA safety communication about the SD
Devices
FDA has sent a letter to healthcare professionals that emphasizes the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR) using stent graphs. “Regular imaging surveillance, within 30 days of EVAR and annually thereafter, may help identify adverse events such as endoleaks,
Devices
FDA has cleared a Teleflex expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous coronary interventions (CTO PCI). CTOs are complete blockages in coronary arteries that result in profound regional reduction of coronary blood flow (ischemia), according to the company. Devices receiving
Devices
Speaking during a 2/22 online presentation sponsored by Friends of Cancer Research, Reps. Donna DeGette (D-CO) and Larry Buschon (R-IN) stressed their determination to see approval of the VALID Act (Verifying Accurate Leading Edge IVCT [in vitro clinical test] Development Act of 2021 during the current Congress.
Devices
FDA says the 12/22/21 Arrow International recall of its Arrow-Trerotola percutaneous thrombolytic device is Class 1. An agency notice says the company recalled 24,895 units manufactured between 1/1/20 and 12/31/21 and distributed between 2/1/20 and 12/31/21. The device
Devices
FDA has cleared a Viz.ai 510(k) for the Viz Aneurysm module and its use on the Viz Intelligent Care Coordination Platform for detecting suspected cerebral aneurysms from computerized tomography angiograms (CTAs). The artificial intelligence platform is currently used to coordinate care across several clinical applications, including ischemic and