By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
ResMed settles kickback allegations for $37.5 million
This article has been updated with comments from ResMed. ResMed (NYSE:RMD) has agreed to pay more than $37.5 million to settle five whistleblower lawsuits claiming the company paid kickbacks to doctors, sleep labs and medical equipment suppliers to obtain customer referrals, according to the U.S. Department of Justice. Federal prosecutors alleged that San Diego-based ResMed: […]
FDA recognizes latest ISO 14971 as medical device consensus standard
By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
Senate confirms Dr. Stephen Hahn to lead FDA
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 […]
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