Combination Products
This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.
The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.
The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.
The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.
Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.
Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.
The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.
The Apple Vision Pro mixed reality headset was used during several spine reconstruction surgeries along with surgical support software and mixed reality provided by eXpanded eXistence, the Orlando, FL-based startup announced on 6 February.
Insulet Corporation has recalled its Omnipod 5 App for Android smartphones due to a software error that could throw off the accuracy of insulin dosing by as much as one hundred times the intended amount.
The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.
This week, the Biden administration announced a new council on supply chain resilience that includes health care goals; an apparent enforcement surge against device fraud continued; Siemens won a $5.5m grant to develop a better sepsis test; and the FDA proposed new classifications for wound care products.
Alignment with other relevant regulations, including medtech, should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence, according to MedTech Europe’s director for international affairs.
B. Braun Medical is recalling more than 10,000 pump systems used to deliver drugs. The US FDA has labelled the recall class I, its most serious type, and reported one death associated with the recall.
Women’s health start-ups focusing on areas of high unmet need such as menopause, infertility, preventive care and post-partum care will continue to attract investors, experts say. Meanwhile, machine learning and AI, as well as next gen-treatments such as psychedelic therapy, stand to drive advancements in the space.
At RAPS Convergence in Montreal, former FDA reviewer Rita Lin discussed the ways the agency wants to see developers consider human factors.
During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry.
During a Monday webinar, interventionalists discussed the recent paclitaxel safety scare, as well as what it might say about the future of device research.
Discussing combination products, the CDRH alum bemoans the ‘handcuffs’ that prevent health authorities from making progress. ‘Industry needs to take this bull by the horns and … we have to look beyond just the mature regulators.’