Devices
American College of Cardiology chief innovation officer Ami Bhatt has been selected to serve a four-year term as chair of FDA’s recently created Digital Health Advisory Committee. The committee was established 10/2023 to provide advice on complex scientific and technical issues related to digital health technologies (DHTs)
Biologics
AdvaMed says it supports FDA’s long-standing bioresearch monitoring (BIMO) program and the provision of the FDA Omnibus Reform Act of 2022 that codified the program into law. In its comment on an FDA draft guidance on BIMO inspection processes and practices, AdvaMed says the agency should clarify that
Devices
FDA has approved Medtronic’s Simplera continuous glucose monitor (CGM). The company says Simplera is its first disposable, all-in-one CGM that is half the size of previous company CGMs. “The discreet design simplifies the insertion and wear experience, eliminating the need for overtape,” it says.
Devices
CDRH has published a discussion paper on health equity for medical devices to solicit public input on the issue. In the paper, the Center describes factors and considerations that may be important for sponsors and other relevant parties as they develop medical device clinical studies. Specifically, it says, the paper
Devices
Smiths Medical is correcting software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may occur if the device is not updated with the latest software. Potential issues that non-updated software can contribute to include upstream occlusion alarm failure, unresponsive stop
Drugs
Attorney James Beck (Reed Smith) says the Supreme Court decision in Loper Bright overturning judicial deference to administrative agencies could lead to significant changes to FDA’s ban on off-label speech. Writing online in the Drug and Device Law Blog, Beck says FDA has been relying on a “very
Devices
Medtronic is recalling (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses. These can occur during procedures when the device may fail to issue an electromyography tone when the NIM probe is placed on a nerve, a recall notice
Devices
Foundation Medicine is petitioning FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection that include one or more companion diagnostic indications from Class III to Class II. Foundation’s just-released 6/28 petition says the genomics company believes “there is sufficient
Devices
FDA has cleared a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscope’s compatibility with Advanced Sterilization Products’ (ASP) Sterrad 100NX Sterilizer. “The collaboration between Pentax Medical and ASP has resulted in a groundbreaking advancement in addressing the ongoing challenges of duodenoscope reprocessing,” Pentax says. “The
Devices
FDA has updated an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021. The update includes links to company-provided information about the affected devices. FDA says many Exactech joint replacement devices (including knees, ankles, and hips) were shipped in defective packaging bags. “The defective bags were
Devices
FDA has approved Inspire Medical Systems’ Inspire V therapy system which includes the next generation neurostimulator and an associated Bluetooth patient remote and physician programmer for treating sleep apnea. Inspire’s implant is designed to deliver gentle pulses to airway muscles to keep the airway open so patients can breathe
Devices
FDA has cleared a DePuy Synthes 510(k) for its VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty (UKA). The expanded indication builds upon the previously cleared VELYS Robotic-Assisted Solution platform used in total knee arthroplasty, the company says. “The UKA application is designed for both
Devices
FDA has cleared a Teleflex 510(k) for its Ringer Perfusion Balloon Catheter (PBC) for use in percutaneous transluminal coronary angioplasty (PTCA) procedures. The device is described as a rapid-exchange 0.014 inch compatible catheter with a helical balloon at its working end. “When inflated, this balloon approximates a
Devices
FDA has cleared a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System. The next-generation device can be utilized through a sacral alar iliac trajectory in S1 or S2 to provide maximum fixation across the sacroiliac joint, the company says. It features implants paired
Devices
A 3/11-3/20 FDA inspection at the Amco International Manufacturing & Design manufacturing facility in Brooklyn, NY, determined that it manufactures replacement batteries for automated external defibrillators (AED) and that the medical devices do not have an approved PMA in effect. A just-released 6/25 Warning Letter
Devices
FDA has approved Guardant Health’s Shield blood test for colorectal cancer (CRC) screening in adults 45 years of age and older who are at average risk for the disease. It is the first blood test to be approved by the agency as a primary screening option for CRC that
Devices
FDA has granted Elixir Medical a breakthrough device designation for its novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary Bioadaptor System, for use in improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.
Devices
A new blog post from FDA’s Digital Health Center of Excellence (DHCoE) outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled medical devices (AI lifecycle). The post provides an AI lifecycle (AILC) concept diagram that highlights systematic methods related to data and model
Devices
FDA has cleared a bioMérieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini. Designed for use on the company’s point-of-care Biofire Spotfire system, the panel is described as a unique multiplex polymerase chain reaction test that detects five of the most common viral and
Devices
Medtronic’s Xomed unit has recalled (Class 1) its neuromonitoring device, NIM Vital Nerve Monitoring system, due to the potential for false negative responses. A recall notice says the company notified consignees on 06/24/2024 that Medtronic had developed software version 1.5.4 to address the issue and
Drugs
Attorney Julie Tibbets (Goodwin) has identified the two most common bioresearch monitoring (BIMO) violations shown in FY 2023 Warning Letters to clinical investigators. She says the most common violations were: * failure to ensure that the investigation was conducted according to the investigational plan; and * failure to submit an IND application
Devices
After a 28-year career in federal service, CDRH director Jeff Shuren says he is retiring later this year. Deputy Center director for transformation Michelle Tarver will serve as acting Center director beginning 7/28. To ensure a smooth transition, Shuren is moving to the Commissioner’s Office while FDA