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FDA hopes new disruptive wearables will lead to ‘universal digital future in healthcare’

The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery”.


FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.


FDA probes paclitaxel-eluting stents, balloons

The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.


Surgical staplers and staples linked to 41K+ injury or malfunction reports

FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.


When should you involve the FDA in your clinical trial planning?

When should you involve the FDA in your clinical trial planning?


FDA Issues Guidance for New Breakthrough Devices Program

The FDA released draft guidance on a new program aimed at expediting access to breakthrough medical devices.


Medical Device Reimbursement & Market Access - Think Ahead

When being introduced to the world of market access and health economics, the staggering number of abbreviations can be overwhelming: HTA, QALY, DRG... What should we make of all these terms and how should we interpret them? Download this white paper and discover reimbursement and market access in key markets, success factors, the decision makers, and differences in payment systems.


FDA sets March dates for microbiology, neurology device panel meetings

The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases.


FDA launches pilot to shorten some 510(k) approval times

The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets.


FDA to revamp medtech cybersecurity - with your help

FDA recently announced that it is taking additional steps to boost medtech cybersecurity, and it’s seeking outside help to do so.