Devices
FDA has cleared a Welldoc 510(k) to add a new feature to its digital health product BlueStar Rx which supports individuals using long-acting insulin. The Insulin Adjustment Program (IAP) supports the process of basal insulin titration by health care providers for adults with Type 2 diabetes, according to
Devices
FDA has granted Noctrix Health a Breakthrough Device Designation for its wearable NTX100 neuromodulation therapy designed for treating adults with primary moderate-severe restless legs syndrome (RLS) who are refractory to medications. RLS is the second most common sleep disorder in the world and impacts over 10% of the adult
Devices
Medtronic has recalled the auto-registration feature of its StealthStation Deep Brain Stimulation (DBS) Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device. An FDA recall
Devices
FDA is investigating MicroGenDX, a Texas laboratory that was dropped by a Florida hospital chain due to what it said were delayed and unreliable Covid-19 test results. USA Today reports that AdventHealth, which has 45 hospitals in nine states, terminated its Florida contract with MicroGen DX over questions about
Devices
FDA has cleared a Gynesonics 510(k) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation. The device integrates an intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device to provide an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids, according to the
Devices
Medtronic has recalled (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of the pump may tear and the strain relief screw may break during assembly prior to implant but might not be noticed until, during or after the
Devices
FDA has released a reference panel to support its evaluation of diagnostic tests for Covid-19. “Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance,” the agency says. “Nucleic acid tests identify infection by confirming
Devices
FDA has posted a list of recent and upcoming enhancements to CDRH’s Electronic Medical Device Reporting (eMDR) system. The post says the eSubmitter client is updated concurrently with eMDR, but AS2 (gateway to gateway connection) submitters should use the information in the post to plan system updates to align
Devices
FDA has denied an 11/27/17 petition submitted by S. Albert Edwards, a Lincolnshire, IL, pharmacist, asking that the agency investigate Edwards Lifesciences’ marketing of its Myxo ET Logix 5100 annuloplasty ring between 2007 and 2009 without agency 510(k) clearance or PMA approval. The denial letter says FDA
Devices
FDA has denied a 9/6/06 Public Citizen Health Research Group petition asking it to revoke the Cyberonics PMA approval for its Vagus Nerve Stimulation device for managing treatment-resistant depression (TRD). The petition claimed that the device was “ineffective” for TRD and has not demonstrated a reasonable assurance
Devices
U.S. senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) have sent a letter to FDA asking for clarification on its temporary policy for manufacturing alcohol-based hand sanitizer products during the Covid-19 pandemic. In March, the agency released a temporary guidance on ethanol used in hand
Devices
Reuters reports exclusively that a shipment of Russian Aventa-M ventilators was negotiated by president Donald Trump with Russian president Vladimir Putin and was received by the Federal Emergency Management Agency (FEMA) 4/1 without oversight from FDA. The news service says the ventilators were sent to New York and
Devices
FDA says that healthcare facility reprocessing staff should remember to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) Sterrad sterilization systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the Covid-19 pandemic. An agency online notice says
Devices
FDA has published an immediately-in-effect guidance, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, containing agency policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the Covid-
Devices
FDA has cleared a Smart Medical Systems 510(k) for the G-Eye Colonoscope. The device is a standard colonoscope which Smart remanufactures by installing its proprietary G-Eye balloon on the distal bending section of the colonoscope. During colonoscopy, the G-Eye colonoscope is inserted in the standard technique,
Devices
A 5/15 CDRH virtual town hall discussed a joint FDA, National Institutes of Health (NIH), Veterans Administration (VA) project on 3D printing of nasal swabs during the Covid-19 public health emergency. Participants noted that an FDA Covid-19 policy guidance intends to help accelerate the availability of novel
Devices
A 5/11 CDRH Webinar reviewed the provisions in a 5/6 immediately-in-effect guidance requiring manufacturers of certain medical devices to notify FDA of an interruption or permanent discontinuation in the manufacturing of the specified medical devices during a public health emergency. CDRH Division of All Hazards Response,
Devices
FDA has issued an immediately-in-effect guidance, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the
Devices
FDA has publicly posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the guidance on Covid-19 tests during the public health emergency. An agency statement (with links to removal list and applicable guidance) says that antibody tests on the
Drugs
The Stericycle Q1 2020 recall report projects a significant surge in FDA drug and medical device enforcement activity once the Covid-19 public health emergency dies down. The report says there is a good chance there will be a downturn in medical device recall activity in at least the second
Devices
The American Hospital Association, Association of periOperative Registered Nurses, and AdvaMed have issued a document with reentry guidance for healthcare facilities and medical device representatives. “The following principles are intended to guide facilities, healthcare personnel, and medical device representatives as they adopt access policies that support safe reentry of medical
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its Vertebral Compression Fractures an artificial intelligence product that the company says automatically identifies findings suggestive of compression fractures to help clinicians to determine if patients are at risk of osteoporosis. Zebra says its algorithm is designed to detect vertebral