Posts by cstephenson@legacymedsearch.com
Viseon, Inc. Announces US FDA Clearance and Clinical Use of its Advanced High-Definition Real Time Imaging Technology for Minimally Invasive Spine Surgery
Viseon, Inc. today announced US FDA clearance and initial clinical use of their Voyant System, integrating minimally invasive surgical (MIS) access with real time high definition imaging technology for more efficient procedural workflow, which enhances a clinician’s intraoperative visualization, providing a more accurate, precise and unimpeded view of the operative field. The Viseon technology offers…
Read MoreBiotronik First to Land MDR Certification for a High-Risk Device
Biotronik said that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. The newly certified device is Biotronik’s Renamic programmer software, which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchronization therapy systems, according to…
Read MoreMinimally Invasive Biopsies Provide Maximum Pathology Data
Current pathology techniques for analyzing biopsy tissues are lacking in their ability to detect cancer in small samples. Being able to rapidly study the distribution of protein expression within cells, gathered from minuscule samples, could be an important tool for early diagnosis and monitoring of cancer. Now, researchers at National University of Singapore have reported…
Read MoreSaranas Launches Early Bird® Bleed Monitoring System in the U.S.
Saranas, Inc. announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors. Saranas will demonstrate the device in Booth 1755 at the Transcatheter Cardiovascular Therapeutics (TCT) Conference…
Read MoreFDA Phase 1 Trial Shows Hydrogel to Repair Heart Is Safe to Inject in Humans—A First
Ventrix, a University of California San Diego spin-off company, has successfully conducted a first-in-human, FDA-approved Phase 1 clinical trial of an injectable hydrogel that aims to repair damage and restore cardiac function in heart failure patients who previously suffered a heart attack. The trial is the first to test a hydrogel designed to repair cardiac…
Read MoreCMR Surgical Raises $240M for Versius Surgical Robot
Cambridge, U.K.-based CMR Surgical raised a $240 million Series C round for its Versius surgical robot. CMR Surgical said it will use the funding to launch the Versius surgical robot “imminently” in Europe and Asia, with “further international expansion expected thereafter.” The Series C round included existing backers LGT Lightstone, Escala Capital Investments, Cambridge Innovation Capital, Watrium,…
Read MoreAbbott Wins CE Mark for Pediatric Heart Devices
Abbott said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder. The Masters HP is the world’s smallest mechanical heart valve (15mm) and is designed for implantation in the mitral or aortic position to mimic a healthy heart valve by opening and closing to facilitate blood…
Read MoreFDA Clears ARTIS icono Family of Angiography Systems From Siemens Healthineers
The U.S. Food and Drug Administration (FDA) has cleared the ARTIS icono, a high-precision family of angiography systems from Siemens Healthineers that permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal utilization in neuroradiology and abdominal imaging, while the…
Read MoreFDA Clarifies Refuse-to-Accept Policy for 510(k) Applications
The FDA has updated its final guidance on its “refuse-to-accept” policy for 510(k) submissions. The guidance includes detailed checklists for devices that applicants want to be considered for traditional, abbreviated or special 510(k) clearance. The agency said it will respond to applications within 15 calendar days from submission and will notify applicants if information is missing. When…
Read MoreUltrasound Sensor Aids Diagnosis of Middle-ear Infection
A new type of ultrasound transducer from Fraunhofer should soon be delivering a fast and reliable diagnosis of infection of the middle ear. A U.S. company and the Fraunhofer Institute for Photonic Microsystems IPMS are collaborating on the development and application of this technology. The transducer is integrated in an otoscope and helps physicians decide…
Read More