medical devices

By Dave Muoio 02:50 pm September 26, 2019
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-...

Credit: ECRI Institute

By Dean Koh 12:17 am April 2, 2019
Last week, ECRI Institute, a nonprofit that focuses on healthcare quality, announced that it will be launching its first medical device evaluation laboratory outside the US. The independent lab, located in Selangor, Malaysia, will evaluate medical devices used across all care settings in Europe and Asia. ECRI Institute established its Asia-Pacific office more than twenty years ago to support...
By Leontina Postelnicu 11:12 am February 18, 2019
Paris-headquartered URGO Group has opened applications for its annual mentorship programme, which aims to support and speed up the growth of a European medtech startup through one year of tailored coaching. The business that will be selected will benefit from support ranging from marketing to clinical trial design or product registration, and URGO Group says they could work together to form “...
By Dave Muoio 12:17 pm February 13, 2019
The aging population’s caregiving needs are growing as quickly as the demographic, and a slew of new tech-based products for seniors, their families and providers are cropping up each day in response. But despite the potential voice-first interfaces and inconspicuous sensor-equipped wearables, analysts discussing the senior care technology market at HIMSS19 noted that long-term adoption is...
By Tammy Lovell 10:55 am February 7, 2019
The Association of British HealthTech Industries (ABHI) has reassured its members that a UK product safety mark to replace the CE mark in the event of a no-deal Brexit will not apply to medical devices. In the UK, all medical devices are subject to EU legislation, which requires manufacturers to place CE marks on their products to show compliance to applicable standards. Earlier this week, the...
By Laura Lovett 02:17 pm January 23, 2019
Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway.  The biggest change to the 510(k) program is that instead of testing a new device in comparison to what is already on the market, new technology seeking clearance can be measured against a set of “objective, transparent and well...