Start-ups in the medtech space face many challenges on the way to market, not the least of which is how to prepare for, and comply with, medical device regulations. Here are some points to consider.

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

Modern healthcare, with its dazzling technological advancements, relies heavily on a vast array of medical devices, from ...

Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...

Malaysia has made historic advancement in international regulatory collaboration with the launch of the Medical Device ...

Master market access for medical device software with our expert-led course. Navigate international regulations, understand reimbursement pathways, a ...

However, I suspect that LYRA will wait for more clarity on the regulatory pathway for non-polyp patients before raising a substantial amount.

Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the FDA’s medical device approval standards.

- Regulatory alignment with FDA confirmed, clearing path to pivotal U.S. clinical trial -- 150-page strategic business plan and advanced financial models completed -- Investor outreach launched to ...

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In the United States, the safety of prescription drugs is overseen along two parallel pathways. Federal regulation is provided by the Food and Drug Administration (FDA), which works to ensure the ...