The FDA granted breakthrough device designation to Royal Philips NV for its laser-assisted inferior vena cava (IVC) filter removal device. The Amsterdam-based company designed the device to ablate tissue for removing an IVC filter when previous methods of removal have already failed.
The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization.
On the heels of enrolling the first patient in a pivotal trial of a ventricular restoration system to treat symptomatic heart failure patients in January, Ancora Heart Inc. closed $80 million in new financing on Monday. The startup company plans to use the new funding to speed up this pivotal trial in preparation for FDA approval of its Accucinch ventricular restoration system.
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
In the largest private fundraising round for a U.S. medical device company in the past year, Imperative Care Inc. closed $260 million in a series D financing round on Thursday. The company also acquired its spinoff Truvic Medical Inc., a peripheral thrombectomy developer.
Nanodx Inc. entered into a license agreement with IBM Research to use IBM’s nanoscale sensor technology and develop diagnostic platforms for rapid and cost-effective detection of various diseases, including COVID-19 and traumatic brain injury, among others. This marks IBM’s first collaboration to allow a medical device company to use its nanoscale technology.
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
Looking to increase adoption among more tobacco users, Carrot Inc. expanded the indications for use of its smoking cessation breathalyzer with a new FDA 510(k) clearance to include the claims related to a recent study in the labeling and promotion of the sensor. The clinical trial demonstrated the Bluetooth-enabled sensor’s ability to increase a person’s motivation to quit.
Xilis Inc. closed $70 million in series A financing on July 8 to reduce drug development costs leveraging its technology, with the goal of advancing precision medicine through targeted drug discovery and development. The financing was led by Mubadala Capital with participation from new investors that include GV, formerly Google Ventures, and others.
A large health system in Minnesota recently became the first in the world to have completed a structural heart procedure, or any other surgical procedure for that matter, using any kind of 4D hologram technology. The technology was developed by venture capital-backed startup Echopixel Inc., and it is intended to improve both surgical precision and outcomes in minimally invasive procedures.