Ulster University27d
Biomedical Engineering - PG Cert
The flow of data within a product lifecycle ... skills required to contribute to the development of a new medical device in an industrial setting. The module covers EU and FDA medical device ...
medtechdive6d
Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
Health Affairs26d
FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development ...
Marketplace26d
Bytes: Week in Review — Investments flow into health tech, FDA approves modifying AI medical devices, and California’s AI insurance claim law
Plus, the FDA issues final guidance for makers of AI-enabled medical devices so they can now update their software after approval. And it was a good year for health tech startups — after a not-s ...
STAT28d
FDA’s proposed ban of electric shock devices has taken too long, autism advocates say
When Eagle visited the Judge Rotenberg Educational Center in a suburb south of Boston, with her mother in the early 2000s, the 13-year-old stepped into the brick building and caught a bizarre ...
Food Safety News25d
FDA steps up enforcement of regulations for imported seafood
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from ... are listed below. Use the chart below to view import alerts. Click here to go to ...
The National Law Review26d
FDA Issues New Guidance on Cosmetic Product Registration and Listing
You are responsible for reading, understanding, and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy ...
AngioDynamics Reports Fiscal Year 2025 Second Quarter Financial Results
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding ...
Business Insider8d
Kazia Therapeutics Charts Path Forward for Paxalisib After FDA Feedback
Kazia Therapeutics has provided an update on the regulatory pathway for its drug paxalisib following a Type C meeting with the FDA. The FDA indicated that data on overall survival (OS) from the ...
FierceBiotech29d
FDA clears AngioDynamics’ NanoKnife pulsed field ablation system for prostate cancer
AngioDynamics has obtained an FDA green light for its NanoKnife prostate cancer ablation system, designed to precisely target and destroy tissue without delivering excess heat and the unintended ...
China Internet Information Center5d
China deepens comprehensive reform to strengthen drug, medical device regulation
The guideline stipulates that by 2027, the legal and regulatory frameworks for drug and medical device supervision will be more enhanced, while the quality and efficiency of review and approval ...