Devices
FDA has cleared an AngioDynamics 510(k) for the AlphaVac Mechanical Thrombectomy System, an off-circuit, multi-purpose mechanical aspiration thrombectomy device for the non-surgical removal of thrombi or emboli from the vasculature. The device combines two of AngioDynamics’ proprietary technologies: a new mechanical aspiration handle and its self-
Devices
FDA has announced a 9/17 virtual public workshop entitled “Spinal Device Clinical Review.” The workshop is intended to clarify FDA’s approach to clinical review of spinal devices falling under 21 CFR Part 888. It will also address the major elements that the agency assesses in its review of
Devices
FDA has cleared an Edwards Lifesciences 510(k) for its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff. The device uses machine learning to alert clinicians about the likelihood a patient is trending toward hypotension. Previously, the software was only available for patients using an invasive
Devices
FDA has cleared a Medtronic 510(k) for patient-specific UNiD Rods for use with its CD Horizon, Solera, Voyager and Infinity OCT spinal systems. The rods are designed for each patient and industrially pre-bent prior to surgery to accurately match an artificial intelligence (AI)-driven pre-operative surgical
Devices
In a 6/3 letter to healthcare providers, FDA says Medtronic is no longer selling and distributing its Heartware Ventricular Assist Device (HVAD) system. The letter says Medtronic determined: * there is an increased risk of neurological adverse events and mortality associated with the internal pump; and * there is potential for
Devices
CDRH says its Accreditation Scheme for Conformity Assessment (ASCA) pilot program is on schedule, with 53 test labs having been granted ASCA accreditation. ASCA team member Angela DeMarco told a 5/20 Webinar “the ASCA pilot is in full swing now that test labs have been accredited and review staff
Devices
FDA has granted a de novo marketing authorization request to Cognoa for its Cognoa ASD Diagnosis Aid to help diagnose autism spectrum disorder (ASD). The machine learning-based software is intended to help health care providers diagnose ASD in children 18 months through five years of age who exhibit potential
Devices
A follow-up study of 16,320 patients with atrial fibrillation (AF) found increased use of follow-up healthcare for those who use smartwatches or other wearable devices, compared with those with similar pulse rates who do not use wearables. The open-access study was conducted by researchers from several
Devices
FDA says it is aware of sterility issues with medical devices processed at the Steri Milano SRL Reggiolo and Monza ethylene oxide sterilization facilities in Italy. “FDA became aware that Steril Milano falsified graphs and parameters of sterilization certificates for a variety of FDA regulated products, dating back to 2016,
Drugs
FDA has extended by three months its review of Verrica Pharmaceuticals’ NDA for VP-102 (cantharidin) for treating molluscum contagiosum, a common, highly contagious skin disease The review extension is intended to give FDA additional time to review information (major amendment) recently submitted by Verrica, including a training program and
Devices
A 2/17-2/26 FDA inspection at the DeChoker medical device operation in Wheat Ridge, CO, determined that the firm manufactures the DeChoker tracheobronchial suction device. A 5/10 Warning Letter says the device is adulterated because it does not conform to the current good manufacturing practice requirements of
Devices
Greenlight Guru founder Jon Speer says medical device companies need closed-loop traceability (CLT) to demonstrate identification and traceability in all quality system processes and thus comply with FDA regulations. Writing in an online Quality Digest column, Speer says that with a global regulatory emphasis on CLT, it’s up
Drugs
FDA has approved Amgen’s Lumakras (sotorasib) for treating adult patients with non-small cell lung cancer whose tumors have the KRAS G12C genetic mutation and who have received at least one prior systemic therapy. “This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts
Devices
FDA is recommending that healthcare facilities and personnel transition away from crisis capacity conservation strategies such as using non-NIOSH-approved disposal respirators. An agency notice says the recommendation was made in follow-up to a 4/9 letter in which it recommended a transition away from decontamination or bioburden-
Devices
FDA has given Acutus Medical the green light to initiate its atrial fibrillation clinical trial to assess the AcQBlate Force Sensing Ablation Catheter and System. The trial is expected to enroll 350 subjects to evaluate the device’s safety and efficacy in treating both paroxysmal and persistent atrial fibrillation. The
Devices
FDA has issued two draft guidances on the continuous surveillance of certain approved and cleared devices. The first draft, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, will assist medical device manufacturers subject to Section 522 postmarket surveillance orders by providing (1) an overview of
Drugs
With several sources worldwide declaring 4/2020 that South Korea’s Covid-19 response strategy had successfully “flattened the curve” of the disease, FDA says that country’s experience may be informative for future considerations. The agency has issued a report that particularly examines South Korea’s approaches to development,
Devices
FDA has cleared a ChoiceSpine 510(k) for the Blackhawk Ti Cervical Spacer System. The 3D-printed device is made using the company’s BioBond porous titanium technology, according to ChoiceSpine. It also features a large open graft window for bone graft containment and maximum visualization, and a simultaneous, single-
Devices
Medical Action Industries has recalled its Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator. The applicator was earlier recalled due to the risk of contamination with Aspergillus penicillioides. “If skin preparation products are contaminated with Aspergillus penicillioides, the fungus can cause serious systemic infection, sepsis, illness, and
Devices
CDRH says it is undertaking research efforts to address scientific knowledge gaps in host responses to an implanted metal device, including adverse events, factors that help identify at-risk patients and tests or methods to better predict or identify exaggerated immune responses in patients. The research could also lead to
Devices
Boston Scientific has recalled its VICI SDS and RDS Venous Stent Systems after receiving reports indicating the devices may migrate or move from where they are initially implanted, according to a recall notice. “A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to
Devices
FDA has cleared an Overjet 510(k) for its Overjet Dental Assist product. The software device applies artificial intelligence (AI) in real-time to aid dentists and hygienists in measuring mesial and distal bone levels in bitewing and periapical radiographs for diagnosing and treatment planning of periodontal disease. In clinical