medical device guru

Cardiovascular / Cardiology

FDA 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...

September 18, 2019

Surgery and Surgical Robotics

CMR 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...

September 18, 2019

Cardiovascular / Cardiology

Abbott 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...

September 17, 2019

Imaging Visualization & Navigation

FDA 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...

September 17, 2019

Diagnostics & Healthcare News

FDA 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...

September 16, 2019

Diagnostics & Healthcare News

Ultrasound 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...

September 16, 2019

Diagnostics & Healthcare News

Cochlear and GN Hearing Become World’s First to Support Direct Android Streaming to Hearing Devices Using Bluetooth Low Energy 

Collaboration with Google on hearing aid specification now officially brings direct streaming of music, phone calls and other sound to people with hearing loss. For the first time, people can stream sound from their compatible Android devices to their hearing...

September 12, 2019

Imaging Visualization & Navigation

GE Healthcare Receives FDA Clearance of First Artificial Intelligence Algorithms Embedded On-Device to Prioritize Critical Chest X-ray Review 

GE Healthcare today announced the Food and Drug Administration’s 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s...

September 12, 2019

Cardiovascular / Cardiology

FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System 

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart...

September 11, 2019