New User Fees Will Expedite Med Device Reviews

Source: MassDevice (7/9/12)

"The deal boosted the user fees from $295 million over five years to $595 million in exchange for the FDA meeting performance goals."

MassDevice

President Barack Obama signed the Food & Drug Administration Safety & Innovation Act, enacting the doubling of the user fees medical device companies pay to have the FDA review their products.

President Barack Obama put his pen to the Food & Drug Administration Safety & Innovation Act today, making it the law of the land that the user fees medical device companies pay to have the FDA review their products more than doubles.

The med-tech industry and the federal watchdog agency spent months hashing out the terms of the deal, which ultimately boosted the user fees from $295 million over five years to $595 million, in exchange for the FDA meeting performance goals. . .View Full Article

Cell Pouch Co. Peer Aborts Program Using Like Device
Source: Dr. Douglas Loe (04/03/2025)

The implications for Cell Pouch, an implantable cell delivery vehicle, and the biotech behind it are positive, noted a Leede Financial Inc. report.

Regenerative Medicine Firm OK'd To Advance Trial in T1D
Source: Streetwise Reports (04/03/2025)

Sernova Biotherapeutics Inc. (SVA:TSX.V; SEOVF:OTCQB; PSH:XETRA) says the Data Safety Monitoring Board supports the ongoing evaluation of the biotech's Cell Pouch Bio-hybrid Organ in this indication.

Clean Tech Co. Achieves Record-Breaking Revenue for Exceptional Growth
Source: Streetwise Reports (04/01/2025)

BioLargo Inc. (BLGO:OTCQX) announced in its annual report that in 2024 it saw record revenues and an increase of 45% over the year before. Read why an expert and an analyst both like this clean technology company's story.

FDA OKs Trial of Cell Reservoir in Thyroid Disease
Source: Dr. Douglas Loe (03/10/2025)

In this Phase 1 study, post-thyroidectomy patients will be treated with their own thyroid cells via this implantable delivery device, noted a Leede Financial Inc. report.