Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers. The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated tho hit the U.S. market in “early summer,” Medtronic said. In February the company said it had won CE […]
Imaging
CurveBeam wins FDA 510(k) for InReach extremity cone beam CT
Medical imaging device developer CurveBeam said today it won FDA 510(k) clearance for the InReach cone beam CT imaging system. The Warrington, Penn.-based company’s InReach is an ultra-compact CT scanner designed to provide high-contrast 3D datasets of bony anatomy. The system is designed primarily for the hand, wrist, elbow and lower extremities in non-weight bearing […]
Check-Cap, GE Healthcare hit X-ray capsule milestone, Check-Cap posts Street-beating Q1
Check-Cap (NSDQ:CHEK) said today that it and its collaborative partner GE Healthcare (NYSE:GE) have reached an initial milestone in their X-ray capsule manufacturing capabilities. Check-Cap also saw shares rise after it released 1st quarter earnings that topped the Street. Israel-based Check-Cap said that X-ray sources produced at GE using custom manufacturing methods passed all tests required for compliance […]
Crospon wins FDA 510(k) for next-gen Endoflip system
Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy. The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based […]
7 medtech stories we missed this week: May 5, 2017
From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Biomerics opening new corporate HQ Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The […]
Scopis launches mixed reality spinal surgery navigator with Microsoft’s HoloLens
Scopis Medical said today it launched the Holographic Navigation Platform, a system for spinal surgeries which incorporates Microsoft‘s (NSDQ:MSFT) HoloLens mixed reality system. To use the system, the operating suergon wears the Microsoft HoloLens glasses which communicates wirelessly with Scopis’ Navigation Platform. The system overlays the planned position of the pedicle screws onto the patient […]
Louisiana medical facility sues Philips over MRI scanner issues
A Louisiana medical facility is suing Royal Philips (NYSE:PHG), claiming that an MRI package it received from the company isn’t functioning years after it was initially installed. In the suit, NAZ LLC claims that it expanded its medical facility to include a Philips Ingenia 3.0 Tesla Omega MRI as part of a new neuroscience and […]
Philips touts consistency, reproducibility in HeartModel AI 3DE imaging study
Royal Philips (NYSE:PHG) today released data from a study of automated 3D echocardiogram analyses with its HeartModel A.I. ultrasound software, touting it as an accurate alternative to conventional methodology. Results from the study were published in the European Heart Journal. The study aimed to explore the accuracy and reproducibility of left atrial volume, left ventricular […]
Olympus to acquire Image Stream Medical
Olympus (TYO:7733) said today that its American subsidiary plans to acquire Image Stream Medical for an undisclosed amount. Littleton, Mass.-based Image Stream makes software designed to connect hospital imaging equipment and systems. Center Valley, Pa.-based Olympus Corp. of the Americas said it aims to build a global systems integration platform using the Image Stream tech. “We are very […]
Rivanna wins Health Canada nod for Accuro spinal navigation system
Rivanna Medical said today it won Health Canada approval for its Accuro automatic spinal navigation system for epidural and neuroaxial anesthesia guidance. The Accuro system is a pocket-sized, portable ultrasound guidance device which provides 3D navigation for needle insertions to improve clinician accuracy in placement, the Charlottesville, Va.-based company said. “Accurate needle placement for epidural and […]
GE Healthcare, Lantheus ink PET imaging agent development deal
GE Healthcare (NYSE:GE) and Lantheus Holdings(NSDQ:LNTH) said today they inked a definitive license agreement to continue the Phase III development and commercialization of the investigational flurpiridaz F 18 imaging agent. The imaging agent is designed as a positron emission tomography myocardial perfusion imaging agent that the companies say may improve the diagnosis of coronary artery disease. […]