Search Results for 'pma'
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FDA Approves Endologix's PMA Supplement for AFX2 System
The AFX2 Endovascular AAA System integrates anatomical fixation with an advanced delivery system to facilitate abdominal aortic aneurysm treatment.Michael Barbella, Managing Editor 02.21.23
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Cardiovascular
Bodyport Appoints Medtech Veteran John Lipman as CEO
Co-founder Cory Centen will continue as president and also serve as chief technology officer.Sam Brusco, Associate Editor 06.16.22
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Neurological
Valencia's eCoin for Urinary Urge Incontinence Gains FDA PMA
Nickel-sized neurostimulator is implanted in the leg in a minimally invasive, outpatient procedure.Sam Brusco, Associate Editor 03.02.22
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Cardiovascular
VisCardia's Heart Failure Therapy Gains Breakthrough Designation
Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.NewsWire 04.23.20
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Cardiovascular
Endospan's Aortic Arch Stent Graft Earns Breakthrough Status
Addresses significant unmet clinical need for difficult-to-treat aortic arch anatomy.Business Wire 04.20.20
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FDA Continues User-Fee Related Reviews Through COVID-19
FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.U.S. Food and Drug Administration 04.17.20
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Neurological
FDA Approves Axonics' Next-Gen Implantable Neurostimulator
Decreases recharge interval to once a month.Business Wire 04.14.20
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The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
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FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test
Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.Globe Newswire 03.30.20
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FDA Approves AEGEA Medical's Mara Water Vapor Ablation System
Reduces heavy menstrual bleeding, improves quality of life, and preserves long-term uterine cavity access.Business Wire 03.24.20
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R&D & Design
Pediatric Medical Device Pitch Competition Announces 30 Semi-Finalists
Thirty innovators will compete on March 23, 2020 in a virtual showcase.National Capital Consortium of Pediatric Device Innovators 03.19.20
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Cardiovascular
FDA Approves Endologix's Alto Abdominal Stent Graft System
Seeks to address the current unmet needs of endovascular aneurysm repair.Business Wire 03.17.20
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JenaValve Technology Closes $50 Million Financing
Equity Round led by Bain Capital Life SciencesBusiness Wire 03.16.20
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Intact Vascular Expands Tack Endovascular System Portfolio Offering
New larger implant enables focal dissection repair across a wider range of vessel sizes.Business Wire 03.09.20
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Former Intersect ENT Finance Chief Joins Cardiva Medical Board
Latest addition currently serves on the board of directors and as audit committee chair of Novocure, Minerva, and SI-Bone.Business Wire 02.18.20
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Software & IT
The True Cost of Paper
Rethinking your approach to quality management.Online Exclusives Jon Speer, Founder and VP of QA/RA at Greenlight Guru 02.13.20
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Cardiovascular
Patient Enrollment Completed in Trial for Suture Delivery Device
Study will determine whether AtriCure's LARIAT device can help reduce the incidence of recurrent Afib.Business Wire 02.11.20
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Cardiovascular
Is a Cardiac Pump the Key to Curbing Heart Failure?
Large clinical trial to determine whether treatment change for heart attack patients can help prevent future deaths.Videos Business Wire
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Smith+Nephew Acquires Tusker Medical
Adds the Tula in-office ear tube delivery system to its ENT portfolio.Smith+Nephew 01.24.20
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Neurological
FDA Approves Axonics' Enhanced Neurostimulator Programmer
New programmer offers a fully wireless system that reduces time during surgery and simplifies post-implant device programming.Business Wire 01.21.20
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Change Management, Part 2—Mike on Medtech
Mike Drues and Sean Fenske discuss the potential implications for a medical device manufacturer who mishandles the reporting of a change to a device.Sean Fenske, Editor-in-Chief 01.20.20
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Change Management, Part 1—Mike on Medtech
Mike Drues and Sean Fenske discuss the procedures and best practices for handling change management for a variety of potential revisions to a device.Sean Fenske, Editor-in-Chief 01.20.20
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Cardiovascular | Surgical
JenaValve's TAVR Wins Breakthrough Status
This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease.Business Wire 01.10.20
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Cardiovascular | Neurological
Terumo's MicroVention Wins FDA Nod for Aneurysm Flow Diverter
First flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion.PR Newswire 01.09.20
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Zephyr Valve Scores High in GOLD Report for its Emphysema Treatment
Data affirms that endobronchial valves like Zephyr's are a proven, viable, minimally-invasive treatment option for severe emphysema.Businesswire 01.02.20
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Cardiovascular
First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump
Impella 5.5 with SmartAssist delivers peak flows of greater than six liters per minute.Businesswire 12.12.19
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Cardiovascular
FDA Grants Supplemental-PMA Approval to Impulse Dynamics' Next-Generation Optimizer Smart System
Product offers a new therapy for heart failure patients with reduced ejection fraction.Businesswire 12.10.19
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FDA Approval of Cerapedics’ Bone Graft PMA Supplement
i-FACTOR Peptide Enhanced Bone Graft continues to demonstrate statistical superiority to autologous bone in cervical spine surgery.Cerapedics 11.19.19
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Cardiovascular
PQ Bypass Receives Unconditional IDE Approval From FDA to Start TORUS SFA Stent Graft Study
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years.Business Wire 11.15.19
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Abiomed's Impella Crosses 1,000-Patient Treatment Threshold in Japan
The first patient in Japan was successfully treated in October 2017.Business Wire 11.15.19
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Neurological
FDA Approves Axonics' Sacral Neuromodulation for Urinary Indications
The Axonics r-SNM System was approved to treat overactive bladder (OAB) and urinary retention.Business Wire 11.14.19
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Cardiovascular
FDA Approves Cardiovascular Systems' Coronary ViperWire Advance With Flex Tip
U.S. approval of the rirst and only Nitinol Atherectomy Guide Wire expands the company’s portfolio of products targeting complex coronary disease.Business Wire 11.04.19
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FDA Grants IDE Approval of Pivotal Study Evaluating AVITA Medical's RECELL System
First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction.Business Wire 10.28.19
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FDA Approves Axonics' Sacral Neuromodulation System
The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans.Business Wire 10.21.19
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Beyond 510(k)/PMA: Safer Technologies Program—Mike on Medtech
Sean Fenske and Mike Drues discuss another new program from the FDA—the Safer Technologies Program (STeP)—and the details of it.Sean Fenske, Editor-in-Chief 10.17.19
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Neurological
Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA
Pending approval, the devices could be available Spring 2020.Medtronic plc 10.07.19
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Cardiovascular | Surgical
FDA Approves Abiomed's Minimally Invasive, Forward Flow Heart Pump
Impella 5.5 with SmartAssist can help stabilize a patient after cardiac decompensation and give the heart time to rest and recover.Business Wire 09.26.19
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Axonics Announces One-Year Clinical Results from its ARTISAN-SNM Pivotal Study
Data show patients implanted with the Axonics r-SNM System receive significant improvements in urinary urgency incontinence symptoms and quality of life.Business Wire 09.26.19
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Benefit-Risk Determinations—Mike on Medtech
Sean Fenske and Mike Drues discuss two FDA guidance documents that focus on considerations and uncertainty in making benefit-risk determinations.Sean Fenske, Editor-in-Chief 09.16.19
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Cardiovascular | Neurological
FDA Approves CVRx's Barostim Neo, a New Form of HF Therapy
The Barostim Neo System is considered the world's first heart failure neuromodulation device.U.S. Food and Drug Adninistration 08.19.19
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Cardiovascular | Surgical
AtriCure to Buy SentreHEART for Up to $300M
The acquisition expands addressable market opportunity and complements offerings for the treatment of atrial fibrillation.Business Wire 08.12.19
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Motus GI Adds Two Key Senior Managers to its Executive Team
Management team to drive commercial launch of Pure-Vu GEN2 in the U.S. hospital market.Business Wire 08.06.19
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Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech
Sean Fenske and Mike Drues discuss a relatively new program from the FDA—the Breakthrough Devices Program—and what it offers to medtech manufacturers.Sean Fenske, Editor-in-Chief 08.06.19
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FDA Approves Use of Full-Body MRI for Pivotal Study Patients Implanted With Axonics System
The approval was a result of a supplement filed by Axonics with the FDA under an IDE.Business Wire 08.05.19
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AngioDynamics Receives FDA OK to Initiate Study for Use of NanoKnife in Prostate Cancer Treatment
The prospective, non-randomized pilot study includes six subjects at up to three clinical sites.Business Wire 07.12.19
