China FDA accepting MDCO certificates from Hong Kong-based medical device registration applicants

By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) has begun recognizing certain certifications issued by the Hong Kong Medical Device Control Office (MDCO) for country-of-origin requirements. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily

Medtronic warns on connectivity issue with Guardian Connect app

Medtronic (NYSE:MDT) this month issued a letter to physicians warning them of a potential connectivity issue with the Guardian Connect mobile app. The medtech giant warned that people using the Guardian Connect system to keep track of their blood sugar levels should update to the latest version of the mobile app as soon as possible. Get

Swiss regulators to overhaul export certification system

By Stewart Eisenhart, Emergo Group Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

National Guideline Clearinghouse to live on despite feds bowing out

The nonprofit that has run the recently shuttered National Guideline Clearinghouse (NGC) for 20 years plans to replace the website and run it privately. Funding to support the federal Agency for Healthcare Research and Quality’s (AHRQ) clinical practice guideline website ended on July 16. ECRI Institute, which developed and maintained NGC since its inception in

Proposed medical device regulatory changes to Order No. 650 in China

By Teemo Chang and Stewart Eisenhart, Emergo Group The Chinese government has issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not

Avinger receives FDA clearance for Pantheris altherectomy device

Avinger (Redwood City, Calif.) recently received FDA clearance for its Pantheris image guided altherectomy device that is designed to treat peripheral artery disease (PAD). Pantheris is the first medical device to be cleared for diagnostics and treatment of PAD. The device lets doctors see inside arteries to treat blockages. It features a built-in camera and

How medtech can prepare for the consequences of a ‘Hard Brexit’

Ronald Boumans, Emergo Group On July 5, the Dutch Ministry of Health organized an informative meeting for the medical field about the possible impact the U.K.’s exit from the European Union (EU), Brexit, might have. This is considered a very important issue that may impact many aspects of the Dutch – and European – economy

9 trends in medical device user interface design

By Valerie Ng and Jon Tilliss, Emergo Group As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Here are the top 5 medtech stories of mid-2018

A growing U.S. trade war with China and other countries casts a pall on medtech — and U.S. business in general — in mid-2018. The landscape of the medical device industry continues to evolve, though. There’s a major corporate spinout in the works, as well as a mega-merger that apparently was not to be. Read

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Medtech stories we missed this week: July 13, 2018

From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump

Who’s afraid of the big, bad PMAs?

PMAs at FDA are often a scary process for medical devices developers. But that doesn’t have to be the case, according to Michael Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA. There are many myths around premarket approval, such as the idea that PMAs always require

South Korea changes guidelines for medical device cybersecurity management

By Stewart Eisenhart, Emergo Group In a sign that medical device market regulators are moving toward a uniform approach to cybersecurity risk management, the South Korean government has published new guidelines referencing the UL 2900 cybersecurity standard as well as US Food and Drug Administration recommendations. Get the full story here at the Emergo Group’s

Key questions for the role of post-market surveillance in European MDR

By Mark Leimbeck, Emergo Group Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily

MDR and IVDR publication requirements for user information on medical device manufacturer websites

By Ronald Boumans, Emergo Group Section 23.1 of Annex I of the Medical Devices Regulation (EU) 745/2017 (MDR) and section 20.1 of Annex I of the In-Vitro Diagnostic Medical Devices Regulation (EU) 746/2017 (IVDR) pertain to requirements that looks quite simple: If the manufacturer has a website, it must publish the user information (label, instructions

Medtech stories we missed this week: July 6, 2018

From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Zetta wins FDA clearance for Zoom MRI software Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as