Aerin Medical announced today that a study of its RhinAer technology demonstrated success in treating chronic rhinitis patients. Sunnyvale, California–based Aerin Medical — one of MassDevice’s 20 medical device startups you need to know in 2020 — designed its RhinAer temperature-controlled radiofrequency (RF) technology to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny […]
Imaging
Accuray partners with Limbus AI on adaptive radiotherapy
Accuray (Nasdaq:ARAY) and Limbus AI announced today that they are partnering to augment Accuray’s adaptive radiotherapy capabilities. The partnership aims to leverage Limbus’ artificial intelligence (AI)-driven auto contouring algorithms to enable a streamlined treatment planning process. Sunnyvale, California-based Accuray and Saskatchewan, Canada-based Limbus AI anticipate an integrated offering will be made available beginning in 2023, […]
GE Healthcare says recovery in supply of contrast media is on the way
GE Healthcare (NYSE:GE) announced today that it is on the way toward restabilizing its global supply of iodinated contrast media — a vital imaging agent. The company said its Shanghai facility, previously closed amid COVID-19 restrictions in China, will be close to 100% production capacity by next week. Said GE: “We will continue to work […]
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]
inHeart wins FDA clearance for 3D cardiac modeling software
inHeart announced today that it received FDA 510(k) clearance for its inHeart Models software suite for cardiac modeling. France-based inHeart designed its inHeart Models software to enable the 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use. FDA clearance allows for the expansion of the company’s commercial footprint in the U.S. […]
MedTrace Pharma moves forward on 15 O-water imaging tech
MedTrace Pharma announced the first person scanned in its Rapid-Water-Flow Phase 3 clinical trial, further testing its tech to bring 15 O-water to imaging. The first subject scan took place at Aarhus University Hospital in Denmark, using 15 O-water produced, dosed and injected through MedTrace’s P3 automated delivery system. The clinical trial aims to evaluate […]
HistoSonics, GE Healthcare agree to integrate ultrasound into sonic beam liver therapy
HistoSonics announced today that it agreed with GE Healthcare to use its ultrasound imaging to power novel sonic beam therapy. Minneapolis-based HistoSonics’ agreement formalizes ongoing efforts to use GE Healthcare’s Logiq E10 Series ultrasound imaging platform to power the real-time visualization features of HistoSonics’ sonic beam liver therapy platform. Under the agreement — and upon […]
Globus Medical announces first surgeries with Excelsius3D
Globus Medical (NYSE:GMED) announced today that the first surgeries were performed with its Excelsius3D imaging platform. Audobon, Pennsylvania-based Globus Medical designed its intelligent, intraoperative 3-in-1 imaging platform as a mobile X-ray system for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients. Its indication covers where a physician benefits from 2D […]
OncoRes Medical raises another $12.5M
OncoRes Medical announced that it raised $12.5 million for its handheld imaging device for identifying cancer cells. Perth, Western Australia-based OncoRes designed its imaging system to facilitate real-time tumor assessment, helping surgeons more accurately identify and remove cancerous tissue, including for breast cancer. The company won FDA breakthrough device designation in October 2020 for the […]
New FDA clearance expands indications for Xact Robotics’ ablation system
Xact Robotics announced today that it received FDA clearance for a modification to its Xact Ace robotic system for ablation procedures. Hingham, Massachusetts-based Xact Robotics’ FDA clearance allows for a modification to the already-cleared Xact Ace system, expanding the indication for CT-guided percutaneous procedures for the system designed to support robotic insertion and steering of […]
GE Healthcare to invest $50M in Pulsenmore to enter homecare segment
GE Healthcare (NYSE:GE) announced today that it entered into an agreement to invest up to $50 million toward homecare ultrasound technology. Chicago-based GE Healthcare’s investment in Israel-based startup Pulsenmore aims to accelerate the global adoption of Pulsenmore’s homecare ultrasound solutions and will also back the company’s efforts to garner FDA clearance and expand commercially. On […]