HIMA urges third-party review system
The Health Industry Manufacturers Association is urging medical device companies to take increasing advantage of a third-party review system within the Food and Drug Administration to gain quicker approval for their products.Last month HIMA passed a
The Health Industry Manufacturers Association is urging medical device companies to take increasing advantage of a third-party review system within the Food and Drug Administration to gain quicker approval for their products.
Last month HIMA passed a resolution reminding companies to use the third-party review system. HIMA represents more than 800 manufacturers of medical devices, diagnostic products, and medical information systems.
The Food and Drug Administration Modernization Act, passed three years ago, devised the third-party system in response to a growing backlog of FDA applications and a dearth of personnel to complete the reviews. The act created a group of scientific and industry experts qualified to grant FDA approval for medical devices, said Linda Ruckel, HIMA spokeswoman.
HIMA members may be hesitant to use the third-party review system for product approval because they arent used to it, Ruckel said.
We believe its a good thing. A lot of times (members) will go for the old tried and true way rather than a new format, Ruckel said. We know its out there and we want to encourage (companies) to use it more.
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
SNMMI: Botox May Facilitate Relief from Dry Mouth Side Effect of PSMA-Targeted Radiopharmaceuticals
June 25th 2025For patients being treated with radiopharmaceutical agents for metastatic prostate cancer, the combination of botulinum toxin and an anti-nausea patch led to a 30 percent reduction in PSMA uptake in the salivary glands, according to preliminary research findings presented at the SNMMI conference.
