The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer […]
Imperative Care raises $85m
Neurovascular device company Imperative Care (Campbell, Calif.) said today that it has completed the initial closing of an $85 million Series C financing round to support the commercial launch of its portfolio. The round was co-led by new investors Ally Bridge Group and Bain Capital Life Sciences. Existing investors Ascension Ventures, Delos Capital, Rock Springs […]
Peregrine Ventures raises $115m
Peregrine Ventures said today that it has raised $115 million for its fourth medtech fund. The raise brings the Israel-based VC firm’s total managed funds and co-invest capital to $400 million, the company noted. Peregrine 4 will continue to invest in early-stage and late-stage rounds of medical technology startups, the company said in a news […]
FDA details framework for abbreviated 510(k) medical device review pathway
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published a high-level framework for its Safety and Performance Based Pathway, an expedited 510(k) premarket review process for qualifying medical devices announced earlier in 2019. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
GenapSys secures $90 million in bid to upend sequencing
Following the raising of a $90 million Series C, privately held GenapSys will begin rolling out a line of low cost electronic-based genetic sequencing machines that it says could upend the research and clinical testing industries. CEO Hesaam Esfandyarpour says the Redwood City, Calif.–based company’s Sequencer, a table-top device that carries a price tag that’s […]
Making your GCP questions easier
Toni Hegyi, Manager, Quality Assurance at IMARC Research, Inc. No matter where you land on the clinical research spectrum, chances are you have encountered some challenges with interpreting and/or implementing Good Clinical Practice (GCP) guidelines. With so many trial designs and research settings, it can be difficult to know how to appropriately apply GCP and […]
Indian CDSCO announces medical device, IVD regulatory updates
By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic products. 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 reflect those […]
EU regulators clarify Notified Body requirements ahead of MDR
By Stewart Eisenhart, Emergo Group The European Medical Device Coordinating Group (MDCG) has updated a Question and Answer resource document covering compliance requirements related to Notified Bodies and joint assessments under the upcoming Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Get the full story here at the Emergo Group’s blog. The […]
EU MDCG weighs in on medical device certification issues
By Ronald Boumans, Emergo Group On October 4, the Medical Devices Coordination Group (MDCG) issued a guidance document on the validity of certificates issued under the (Active Implantable) Medical Devices Directive (AIMDD), following the Date of Application of the Medical Devices Regulation (EU) 2017/745 (MDR). These so-called “legacy devices” can be placed on the market […]
How to improve usability for wearable injector devices
By Andrew Micek, Emergo Group A new article provides step-by-step tips to help wearable injector medical device manufacturers improve design and reduce common use errors. 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 reflect those of MassDevice.com or […]
DEKRA appointed first Notified Body to European IVDR
By Ronald Boumans, Emergo Group It had already been hinted at the MDCG Stakeholders meeting of September 30th, 2019, but now it is official: DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Get the full story here at the […]
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