Pavmed plans safety study for CarpX following FDA meeting
After a meeting with the FDA, Pavmed (NSDQ:PAVM) said that the agency wants to see more clinical testing for the CarpX device before it can make a decision on whether or not to approve the product.
In August last year, the FDA group reviewing Pavmed’s 510(k) application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period.
The hangup, according to an SEC filing, is that the group is “focused on protection of important structures during the procedure. [The FDA] recommended clinical testing to definitively document pr...
Source: Mass Device - January 11, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Food & Drug Administration (FDA) Wall Street Beat Pavmed Source Type: news
Carpal tunnel syndrome: Mayo Clinic Radio Health Minute
Carpal tunnel syndrome develops when one of the tree nerves that runs through your wrist gets squeezed or compressed. In this Mayo Clinic Radio Health Minute,Dr. Alexander Shin, an orthopedic surgeon at Mayo Clinic, outlines treatment options for?carpal tunnel syndrome. To listen, click the link below. Carpal tunnel syndrome (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - January 10, 2019 Category: Databases & Libraries Source Type: news
Carpal Tunnel Syndrome
(Source: eMedicineHealth.com)
Source: eMedicineHealth.com - January 9, 2019 Category: General Medicine Source Type: news
Pavmed raises $7m in private placement
Pavmed (NSDQ:PAVM) said this week that it inked a deal to sell a senior secured convertible note of $7.8 million to an institutional investor.
The note was sold with an issue discount of $725,000, for gross proceeds to Pavmed of $7 million. Maxim Group, which acted as the placement agent for the transaction, received a 6.5% fee, according to a report filed with the SEC.
The company said that after it consummated the sale of its convertible note, Pavmed repaid the outstanding principal balance and all accrued interest on a senior secured note held by an existing lender. Pavmed dealt a cash payment of $5 million to Scopia H...
Source: Mass Device - December 28, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Featured Funding Roundup Wall Street Beat Pavmed Source Type: news
Doctor warns of the rise in cases of 'selfie wrist'
A San Francisco-based orthopedic surgeon says our obsessive need to take selfies is causing a condition known as 'selfie wrist', a form of carpal tunnel syndrome, due to constant hyperflexing. (Source: the Mail online | Health)
Source: the Mail online | Health - December 27, 2018 Category: Consumer Health News Source Type: news
Health Tip: Warning Signs of Carpal Tunnel Syndrome
-- Carpal tunnel syndrome occurs when the nerve that runs from the forearm to the wrist becomes squeezed or compressed.
The condition can be caused by an injury to the wrist, stress to the joint, rheumatoid arthritis, or repetitive motion of the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 9, 2018 Category: General Medicine Source Type: news
Carpal Tunnel Surgery a Chance to Catch Amyloid Heart Disease
(MedPage Today) -- Need for cardiac imaging may be flagged by tenosynovial tissue biopsy (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - October 15, 2018 Category: Neurology Source Type: news
A light at the end of the carpal tunnel? CDC finds jobs most at risk for syndrome
A new report from the Centers for Disease Control and Prevention released on Thursday shows there are far more jobs that put workers at risk for the carpal tunnel. (Source: ABC News: Health)
Source: ABC News: Health - October 5, 2018 Category: Consumer Health News Tags: Health Source Type: news
Rates of Carpal Tunnel Syndrome in a State Workers' Compensation Information System, by Industry and Occupation --- California, 2007--2014
Occupational risk factors for carpal tunnel syndrome were assessed in various industries in California to determine where the highest need for mitigation lies. (Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - October 4, 2018 Category: American Health Tags: Anxiety Arthritis Depression Health Education Infant Health Mental Health MMWR Morbidity & Mortality Weekly Report Occupational Health Statistics Occupational Safety Physical Activity Pregnancy Sexually Transmitted Diseases (ST Source Type: news
Ask Is Carpal Tunnel Curable
Is Carpal Tunnel Curable? (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - September 10, 2018 Category: General Medicine Source Type: news
Ask How Do You Know Carpal Tunnel Syndrome
How Do You Know When You Have Carpal Tunnel Syndrome? (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - September 10, 2018 Category: General Medicine Source Type: news
Medical News Today: Why do my arms go numb at night?
A feeling of the arms falling asleep can occur at any time of the day or night. If a person experiences this frequently at night, it may be a symptom of an underlying issue, such as carpal tunnel syndrome, vitamin B deficiency, or diabetes. Here, learn more about the causes and prevention of this sensation. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - September 3, 2018 Category: Consumer Health News Tags: Neurology / Neuroscience Source Type: news
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 compr...
Source: Mass Device - August 23, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Food & Drug Administration (FDA) Pain Management Regulatory/Compliance Pavmed Source Type: news
Video: Carpal tunnel syndrome & mdash; results of surgery
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - July 14, 2018 Category: Consumer Health News Source Type: news
Video: Carpal tunnel symptoms & mdash; nonsurgical treatment
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - July 14, 2018 Category: Consumer Health News Source Type: news
