A high-resolution pediatric female whole-body numerical model with comparison to a male model - Ntolkeras G, Jeong H, Zollei L, Dmytriw AA, Purvaziri A, Lev MH, Grant PE, Bonmassar G.
OBJECTIVE. Numerical models are central in designing and testing novel medical devices and in studying how different anatomical changes may affect physiology. Despite the numerous adult models available, there are only a few whole-body pediatric numerical ... (Source: SafetyLit)
Source: SafetyLit - January 27, 2023 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news

Butchertown Clinical Trials helps bring new medical device to market
A medical device has received approval from the Food and Drug Administration after undergoing trials at a Louisville medical facility. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - January 26, 2023 Category: Pharmaceuticals Authors: Laurel Deppen Source Type: news

Follow-up on the IMMDS report and the government's response
This report states that ministers must act urgently to enable women and children avoidably harmed by medical intervention to receive compensation and care. The report finds that families have waited too long for redress or compensation because litigation through the courts was the only option open to them. Ministers had rejected an alternative approach recommended by the Independent Medicines and Medical Devices Safety (IMMDS) independent review more than two years ago ( 2 External 0 0 0 First do no harm Read the review false https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fkingsfundmail.org.uk%2F21A8-86F...
Source: Current Awareness Service for Health (CASH) - January 25, 2023 Category: Consumer Health News Source Type: news

FDA Agrees to Expanded Access Program for the BioVentrix(R) Revivent TC(R) System for the Treatment of Ischemic Heart Failure
Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US SAN RAMON, Calif., Jan. 24, 2023 -- (Healthcare Sales & Marketing Network) -- BioVentrix®, Inc., a privately held medical device company focused on the development of les... Devices, Cardiology, FDA BioVentrix, Revivent TC System, heart failure (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 24, 2023 Category: Pharmaceuticals Source Type: news

Follow-up on the Independent Medicines and Medical Devices Safety (IMMDS) report and the Government's response
This report raises concerns over the government ' s failure to collect data on the number of women who experience complications following surgical mesh surgery or sodium valproate exposure during pregnancy, despite agreeing to these recommendations. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - January 23, 2023 Category: Consumer Health News Source Type: news

FDA: Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration has issued an Emergency Use Authorization for certain medical devices related to the COVID-19 pandemic. These authorizations are effective on their date of issuance. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - January 23, 2023 Category: Rural Health Source Type: news

Loophole enables FDA approval of unsafe medical devices, Yale study finds
Manufacturers, through a loophole in the law, can use an unsafe medical device as a basis for FDA authorization to bring it to market. (Source: Yale Science and Health News)
Source: Yale Science and Health News - January 19, 2023 Category: Universities & Medical Training Source Type: news

India targeting global arena with high value pharma, med-tech products, says Mandaviya
Mandaviya said the union government is promoting an enabling ecosystem for innovation in the pharma-medtech sector to become a leader in drug discovery and innovative medical devices. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 18, 2023 Category: Pharmaceuticals Source Type: news

' Normalization' Of Emergency Use Authorizations Concerns Health Experts | ZeroHedge
'Normalization' Of Emergency Use Authorizations Concerns Health Experts Authored by Marina Zhang via The Epoch Times (emphasis ours), The Food and Drug Administration (FDA) has approved an unprecedented number of emergency use authorizations (EUAs) for drugs, tests, and medical devices since theā€¦#pfizereua #financially #clinicians #mrna #joeraedlegettyimages #fla #nurphoto #pdfua #cdc #aneua (Source: Reuters: Health)
Source: Reuters: Health - January 14, 2023 Category: Consumer Health News Source Type: news

Lab Notes: Neuronetics resolves lawsuit; Harmony CEO departs; Ocugen issues results of Covaxin study
This week's local life sciences industry news includes details on a medical device company's legal settlement, a CEO change at one local firm and a management team expansion at another, a new product launch, and more. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - January 13, 2023 Category: Biotechnology Authors: John George Source Type: news

San Fernando Valley Man Pleads Guilty to Selling Used and Counterfeit Medical Devices Used for Skin Tightening and Fat Burning
FDA OCI, Kambiz Youabian, Tarzana, CA, guilty plea, $6 million, scheme, misbranded, counterfeit, device, skin tightening, fat burning, laser, mail fraud, MSY Technologies, Thermagen, Global Electronic Supplies, GES, transducers, dermatology, remanufacture, depleted, PAC keys, (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - January 12, 2023 Category: Medical Law Authors: DOJ Source Type: news

Tap water isn't safe to use in neti pots and other home medical devices. Here's what to do instead
Tap water is not sterile, and using it in home medical devices can result in serious and even deadly infections. But in a study published Wednesday in the journal Emerging Infectious Diseases, one-third of respondents to a survey incorrectly answered that tap water does not contain bacteria or other living organisms. (Source: CNN.com - Health)
Source: CNN.com - Health - January 11, 2023 Category: Consumer Health News Source Type: news

Canon inks partnership with ScImage
Canon Medical Systems USA has signed a strategic partnership deal with enterpris...Read more on AuntMinnie.comRelated Reading: Canon highlights U.S. subsidiary, new products at RSNA 2022 Canon sees rebound in medical equipment sales in Q2 Canon buys NXC to expand Midwest distribution ScImage partners with DiA Imaging Analysis ScImage leverages Microsoft Azure for cloud platform ScImage integrates with U.S. military's EHR software (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 11, 2023 Category: Radiology Source Type: news

Budget 2023: Healthcare tech industry body seeks cut in customs duty, removal of health cess on medical devices
MTaI Chairman and Director General Pavan Choudary said the customs duties and taxes levied on medical devices in India are one of the highest in the world and highest among the neighbouring countries which directly impacts patients' affordability. "As the preparation for the Union Budget 2023 gets underway, we expect a correction in the customs duties and taxes levied on medical devices," Choudary said. (Source: The Economic Times)
Source: The Economic Times - January 11, 2023 Category: Consumer Health News Source Type: news

Jet Medical and Related Companies Agree to Pay More Than $700,000 to Resolve Medical Device Allegations
FDA OCI, JMedComp, Martech, et Medical, criminal, allegations, resolve, civil settlement, device, misbranded, no approval, no clearance, Allevio, SPG Nerve Block Catheter, migraine, headaches, sphenopalatine ganglion, qui tam, whistleblower, false claims, (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - January 9, 2023 Category: Medical Law Authors: DOJ Source Type: news