Varex Imaging (NSDQ:VREX) last week announced that it is closing its Santa Clara, Calif. facility. The closure of the company’s Santa Clara facility is part of an ongoing integration of business acquired from PerkinElmer in May 2017. The Salt Lake City-based company expects operations at the Santa Clara facility to completely stop by the end of […]
How human factors validation investigators identify user groups and populations
By Ella Engels, Emergo Group Imagine you are preparing for a human factors (HF) validation study to bring your medical device to market, and the market research recruiters inform you that it will be very challenging, if not unfeasible, to recruit the required 15 participants per user group. What do you do? Get the full […]
FDA clears RaySearch’s RayStation 8B
RaySearch yesterday announced it received FDA 510(k) clearance for its RayStation 8B treatment planning system. The RayStation 8B is a machine learning treatment planning system for the radiation oncology market. The system uses deep neural networks and is designed for automated treatment planning and automated organ segmentation to improve efficiency and consistency. The framework of […]
Nemaura bids for de novo clearance from FDA for SugarBEAT glucose monitor
Nemaura Medical (NSDQ:NMRD) this week said it submitted a De Novo medical device applications to the FDA for its SugarBEAT non-invasive glucose monitor. The Loughborough, England-based company recently successfully completed clinical studies and two summative human factors usability studies needed to support De Novo submission. Get the full story on our sister site, Drug Delivery Business.
European Commission publishes guidance on responsible person requirements under MDR, IVDR
By Stewart Eisenhart, Emergo Group European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). 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 […]
Procyrion raises $30m Series D for Aortix heart pump
Procyrion said this week that it closed a $30 million Series D round for its Aortix percutaneous blood pump. The Aortix blood pump is designed to treat patients with heart failure and worsening kidney function. The pump is thinner than a pencil and can be placed in less than 10 minutes during a cath-lab procedure. […]
China NMPA releases new eRPS medical device registration system details
By Stewart Eisenhart, Emergo Group Emergo by UL has learned additional details regarding the China National Medical Product Administration’s (NMPA) new electronic medical device registration management (eRPS) system. 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 […]
Teleflex touts large real-world UroLift study
Teleflex (NYSE:TFX) yesterday touted results from a real-world study of its UroLift system for treating prostate disease. The UroLift implant is designed to treat lower urinary tract symptoms from benign prostatic hyperplasia. Wayne, Pa.-based Teleflex paid $1 billion to acquire NeoTract, which developed UroLift, in October 2017. The 1,413-patient retrospective study was designed to evaluate UroLift’s […]
DHS warns on GE Aestiva and Aespire anesthesia devices
The U.S. Homeland Security Dept. yesterday warned of cybersecurity vulnerabilities with the GE Aestiva and Aespire anesthesia devices. The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses discovered by researchers at CyberMDX, said the vulnerabilities could allow an attacker to remotely modify GE Healthcare anesthesia device parameters. The vulnerability comes from a […]
FDA issues final rule for appealing medical device regulatory decisions
By Stewart Eisenhart, Emergo Group A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
5 Wearable Technologies Conference exhibitors you should know
The 34th edition of the Wearable Technologies Conferenceseries is taking place today and tomorrow in San Francisco. Co-located with Semicon West, the Wearable Technologies Conference offers a number of panels to discuss wearables in healthcare and IoT, as well as conference exhibitors and networking opportunities. Here are five companies touting their latest wearable technologies at this […]
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