As a result of the new EU Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark under the previous Medical Devices Directive (MDD), will need to be re-certified.
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So far Sam Barnum has created 30 blog entries.
We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health care system. In this issue, we will discuss another industry sector that may benefit from this global pandemic, digital health.
Browse a variety of recent webinars presented by the team at Boston Healthcare Associates. We will regularly update this library of free life science webinars as we continue to produce them throughout 2020.
The Food and Drug Administration recently published final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists several key considerations for companion diagnostic manufacturers.
At its core, the VALID Act would explicitly grant the FDA authority to regulate LDTs through a risk-based framework that categorizes LDTs as high risk or low risk, with high-risk tests facing approval requirements that are comparable to existing medical device regulations.
COVID-19 is on the verge of becoming a pandemic. Here we highlight Chinese infectious disease management and the regulatory mechanism for clinical diagnostics.
The introduced reimbursement of digital health apps in Germany provides many chances for manufacturers of innovative digital health solutions.
While establishing payment mechanisms is an important part of the DTx value realization chain, creating a clear and differentiated value proposition and an effective value communication strategy are critical, precursive steps to value monetization.
An official statistical report of the 2018 national social health insurance fund, which provides high-level data for an outsider to try to grasp the essential characteristics of China’s healthcare funding and delivery system and understand the challenges an industry player as well as the Chinese government payer are facing...
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA evaluated a total of 166 Dossiers - 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations.