Zephyrnet Logo

Tag: MDD

Vienna-based Syntropic secures seven-figure funding to develop new treatment for Major Depressive Disorder | EU-Startups

Syntropic Medical, a medical device company spun out of the Institute of Science and Technology Austria (ISTA) by Mark Caffrey, Jack O’Keeffe, Dr. Alessandro...

Top News

Neurolief’s Relivion® Secures Regulatory Approval in Japan, Pioneering At-Home Migraine Treatment | BioSpace

TAMPA, Fla., Jan. 9, 2024 /PRNewswire/ -- Neurolief, a global leader in medical devices delivering groundbreaking neurotechnology innovations for the treatment of Neurological and...

TGA Guidance on Evidence from Comparable Regulators: Inclusion in the ARTG | RegDesk

The new article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register...

Complaints handling mistakes – Why?

Complaints handling mistakes, medical device reporting, and CAPA are the most common reasons for FDA 483 inspection observations, but why? Reasons for FDA 483s related...

RF Medical Completed the Transition to European Medical Device Regulations (MDR) for Class IIb Medical Devices | BioSpace

SEOUL, South Korea, Oct. 24, 2023 /PRNewswire/ -- RF Medical, specializing in the treatment of tumors and veins with various radiofrequency ablation products, announced today...

MHRA Guidance on Registration Reliant on Expiring CE Certificates: Overview – RegDesk

The article provides a general overview of the regulatory requirements for the registration of new medical devices relying...

Trying Shrooms Once Can Get Rid of Depression for Weeks Says New Medical Study

Just One Magic Mushroom Dose Enough To Treat Depression For Weeks, Says New Study Depression affects millions of people worldwide. Some people who experience...

MDR Extension Timeline for Implementation

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

MDR Extension According to Regulation 2023/607

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

Variations Between FDA and EU MDR Requirements for Clinical Investigations

Clinical investigations are defined within both FDA and EU MDR as the systematic investigation involving one or more human subjects, undertaken to collect data...

Psilocybin treats symptoms of major depression after just one dose, study shows – leafie

A study published in the Journal of American Medicine suggests that one dose of psilocybin, the active ingredient in magic mushrooms, can have a...

Reflecting on the Second Anniversary of the EU Medical Device Regulation

As we reach the second anniversary of the date of application of the EU’s MDR, it’s an excellent opportunity to reflect on the journey...

IFUcare: its history, evolution of eIFU regulations and the road ahead

<!----> IFUcare’s journey started way back in 2007. Its inception coincided with the publication of MEDDEV. 2.14/3 rev.1,...

Latest Intelligence

spot_img
spot_img