Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines' Initial Release

USA – Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines’ Initial Release

Xcertia — an mHealth app collaborative founded by the American Medical Association (AMA), American Heart Association (AHA), DHX Group, and Healthcare Information and Management...
MDIC Works to Standardize Oversight of NGS-based Assays

USA – MDIC Works to Standardize Oversight of NGS-based Assays

To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday...
CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

USA – FDA proposes exempting some flow cytometers from 510(k) requirements

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to...
FDA Promises Flexibility for Stem Cell Trials

USA – CDRH Classifies Software App for Contraception into Class II

Following the 2018 US Food and Drug Administration (FDA) approval of the country’s first mobile medical application indicated for contraceptive use, the agency issued...
Gottlieb to Resign as FDA Commissioner

USA – Gottlieb to Resign as FDA Commissioner

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb unexpectedly announced Tuesday that he will resign in one month. In his resignation letter (read it...
Capturing Device Identifiers for Non-Sterile Orthopedic Implants at Point of Care

USA – Capturing Device Identifiers for Non-Sterile Orthopedic Implants at Point of Care

Orthopedic surgeries can be life-changing—enhanced patient mobility and quality of life are often expected outcomes. With so much at stake, best practices to document...
FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

USA – FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has...
Notification pathway for Class I devices nearing publication in Brazil

Brazil – Notification pathway for Class I devices nearing publication in Brazil

Publication of Brazil’s regulation on notification market pathway for Class I devices expected soon. Qualifying low-risk medical devices will not undergo full ANVISA...
FDA warns consumers to avoid using thermography devices to detect breast cancer

USA – FDA warns consumers to avoid using thermography devices to detect breast cancer

The U.S. Food and Drug Administration has issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda...
FDA Unveils 5 Guidances on Broadening Cancer Clinical Trial Eligibility

USA – CDRH Issues Guidance on Brain-computer Interface Devices

Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center...

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