FDA wants Pavmed to re-submit for CarpX carpal tunnel device

The FDA group reviewing the 510(k) application for Pavmed‘s (NSDQ:PAVM) CarpX device wants the company to resubmit the application. The FDA told the company that it had not reached a consensus within the review period set by the agency’s rules. To extend the review process, the FDA recommended that Pavmed resubmit the application. In a filing with the SEC, Pavmed said it initiated the submission this week and hopes to land a pre-submission meeting in the next 45 days. The company’s minimally-invasive CarpX device is designed to treat carpal tunnel syndrome. The device enables a physician to relieve compression of a patient’s median nerve without the use of an incision. The ultrasound-guided system features a balloon catheter with bipolar radio-frequency cutting electrodes, according to Pavmed. Once the device is activated, it creates a space to protect the nerve from the cutting electrode and decompresses the nerve by dividing the transverse carpal ligament. “We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions,” CMO Dr. Brian deGuzman explained last year. “Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasiv...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Pain Management Regulatory/Compliance Pavmed Source Type: news

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Journal Name: Journal of Perinatal Medicine Issue: Ahead of print
Source: Journal of Perinatal Medicine - Category: Perinatology & Neonatology Source Type: research
New J. Chem., 2020, Accepted Manuscript DOI: 10.1039/C9NJ05830C, PaperLinsen Huang, Liangxing Zhang, Deyu Bao, Xiaoqing Jiang, Junhua Li, Xiaosong Sun The present study focuses on the synthesis and the characterization of ternary photo-catalyst rGO-Sb4O5Cl2-Sb2S3. A series of rGO-Sb4O5Cl2-Sb2S3 samples were synthesized by the ultrasonic assistant chemical co-precipitation method, and the... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - New J. Chem. latest articles - Category: Chemistry Authors: Source Type: research
Authors: Ertel KA, Hallam JE, Hillman AR Abstract BACKGROUND: Individuals participating in exercise beyond their level of fitness may be at higher risk for exercise-induced muscle damage, however the impact of training status on muscle damage development is not well understood. The purpose of this study was to measure skeletal muscle damage and soreness after five days of high and low intensity exercise in previously trained and untrained individuals. METHODS: Eighteen males and females (9 trained and 9 untrained) completed five consecutive days of high intensity (HI) exercise and five consecutive days of low i...
Source: Journal of Sports Medicine and Physical Fitness - Category: Sports Medicine Tags: J Sports Med Phys Fitness Source Type: research
Authors: Monte A, Nardello F, Pavei G, Moro S, Festa L, Tarperi C, Schena F, Zamparo P Abstract BACKGROUND: The aim of this study was to determine the influence of spring mass model characteristics (e.g. stiffness) and Achilles tendon proprieties in determining the energy cost of running in half marathon runners. METHODS: Achilles tendon characteristics (i.e. cross sectional area -ATCSA- and resting length - ATL-) were measured on 32 males by means of an ultrasound apparatus the day before a half marathon race. After these measurements the energy cost of running (C) was determined while the subjects run on a tr...
Source: Journal of Sports Medicine and Physical Fitness - Category: Sports Medicine Tags: J Sports Med Phys Fitness Source Type: research
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Source: Journal of Vascular Surgery - Category: Surgery Authors: Tags: Letter to the Editor Source Type: research
Regional anesthesia (RA)-induced vasodilation increases the proportion of patients with vein anatomy suitable for arteriovenous fistula (AVF) creation. The functional outcomes of AVFs created with veins initially small for size on preoperative duplex ultrasound mapping ( ≤2.4 mm) that are recruited under RA have not been clearly defined. We aimed to evaluate freedom from revision or thrombosis, time to first cannulation, and reintervention rates of AVFs created with veins recruited after induction of RA.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Tags: Clinical research study Source Type: research
I haven't used Stimwave since fellowship. Anyone using their technology for peripheral nerve stim? Results? Pros/Cons and feedback from patients? If I were going to use it, it would probably be for suprascapular neuralgia, genicular nerualgia, and/or SI joint pain vs cluneal neuralgia, when other options have failed (i.e. RF).
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
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Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
Within 24 hours of her second daughter’s birth, Dyane Harwood felt elated. From the moment she came home from the hospital, she started writing. Furiously. She wrote while nursing her daughter and going to the bathroom. She wrote on her hands, on the bathroom mirror, inside books and on tabletops. She yearned to write down every thought she was having. She wrote so much that her wrists ached—her carpal tunnel returning—and she was in constant pain. She also had endless energy and a newfound enthusiasm for life. She felt like she could run a long race. She couldn’t sit still, and her speech was fast ...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Bipolar Disorders General Health-related Mental Health and Wellness Self-Help Sleep Women's Issues Johns mood disorder Motherhood Parenting postpartum bipolar disorder postpartum depression Postpartum Disorder Source Type: blogs
Pavmed (NSDQ:PAVM) said this week that it plans to temporarily cut the exercise price of its outstanding Series W warrants in half. Each of the New York-based company’s outstanding warrants is currently exercisable at $5.00 apiece for one share of common stock. After Pavmed files tender offer materials, each warrant will have an exercise price of $2.50 per share. The company said it expects the offer will be good for 20 business days, but it could decide to extend the deal. “Pavmed is providing this opportunity to exercise warrants at a reduced price in order to encourage holders to exercise a meaningful p...
Source: Mass Device - Category: Medical Devices Authors: Tags: Funding Roundup Pain Management Wall Street Beat Pavmed Source Type: news
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