Hologic (NSDQ:HOLX) said today it won FDA premarket approval to add Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology to its 3Dimensions breast tomosynthesis machines. With the new approval, the Marlborough, Mass.-based company said its system provides enhanced resolution 3D imaging which it touts as the industry’s fastest, highest resolution 3D images. Images through the […]
Imaging
This new technology could help surgeons clear out leftover cancer cells
In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew Claney] After his wife died of breast cancer in 2003, David Lee stepped away from […]
Philips launches tele-ultrasound system for Lumify platform
Royal Philips (NYSE:PHG) said today it launched a tele-ultrasound equipped version of its Lumify portable ultrasound designed to work with compatible smart devices and developed through a partnership with Innovative Imaging Technologies. The system is powered by IIT’s Reacts collaborative platform, and is designed to allow remote clinicians to connect through the Lumify system, streaming audio, video […]
Samsung wins FDA nod for next-gen RS85A ultrasound
Samsung Electronics (LON:BC94) subsidiary Samsung NeuroLogica said today it won FDA 510(k) clearance for its RS85A ultrasound device. The RS85A system features new Samsung technology including the MV-Flow feature which allows for the visualization of slow-flow micro vascularized structures and S-Shearwave Imaging technology which quantifies the elasticity of tissue or lesions. The newly cleared system also […]
7 medtech stories we missed this week: March 23, 2018
From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]
10 women medtech leaders you should know
There is a women’s leadership gap in the U.S., and women in medtech have been working to alleviate that problem. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S., but only 14.6% are CEOs, 8.1% are top earners and 4.6% are Fortune 500 CEOs. More specifically, […]
Boston Scientific touts safety, effectiveness in Rhythmia mapping system study
Boston Scientific (NYSE:BSX) today released data from the True-HD study of its Rhythmia mapping system and Intellamap Orion mapping catheter, touting it as safe and effective to support treatments of arrhythmias. Results from the trial were presented at a late-breaking clinical trial session at the European Heart Rhythm Association’s annual congress in Barcelona, Spain. The 572-patient […]
FDA tags closing Philips plant for mishandling adverse event reports
Updated to reflect that the FDA document was a Form 483, not a warning letter, and to include commentary from a Philips spokesperson. The FDA recently released a Form 483 it sent to Royal Philips (NYSE:PHG) over issues it found with a Cleveland, Ohio-based plant the company plans to close, citing numerous mishandled adverse event reports […]
Masimo expected to grow through 2025 as it branches out, analyst says
Masimo (Nasdaq: MASI) should enjoy growth through the middle of the next decade, thanks to its exploration of opportunities outside its core market that are more driven by hospital automation, according to a new equity research report out of Barclays. Masimo is on track to having 8–10% top-line growth and 12–15% earnings per share growth through […]
Exact Imaging wins CE Mark for FusionVu micro-ultrasound/MRI fusion application
Micro-ultrasound developer Exact Imaging said today it won CE Mark approval in the European Union for its Fusion Vu application designed for micro-ultrasound/MRI fusion-based targeted prostate biopsies. The newly cleared application allows urologists to perform either cognitive fusion via Cognitivie Assist or micro-ultrasound/MR fusion on a high resolution platform, which the company said provides the “highest real-time […]
7 medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]