Regulatory

Ethicon Receives FDA 510(k) Clearance for VISTASEAL Open and Laparoscopic Dual Applicator Devices

VISTASEAL Dual Applicator is the first product to emerge from recent strategic partnership between Ethicon and Grifols.

Johnson & Johnson Medical Devices Companies 06.19.19

Cardiovascular | Surgical

Cook Recalls PTA Balloon Catheters Due to Balloons Bursting

Multiple complaints were received for balloons in Cook's Advance Enforcer 35 Focal Force PTA Balloon Catheter bursting below the rated burst pressure.

U.S. Food and Drug Administration 06.19.19

Patient Monitoring

FDA OKs Murata Vios' Second-Gen Wireless Monitoring Platform

Second-generation platform collects 7-leads of ECG, heart rate, respiratory rate, SpO2, blood pressure, temperature, pulse rate, patient posture, and activity.

Business Wire 06.19.19

Cardiovascular

FDA Approves Philips' HeartStart OnSite and HeartStart Home Defibrillators

These are the only over-the-counter automated external defibrillators (AEDs) available to consumers in the U.S.

GlobeNewswire 06.19.19

Cardiovascular

SentreHEART Receives CE Mark for LARIAT-RS 50mm

Company also is awarded an expanded indication for left atrial appendage exclusion.

Business Wire 06.18.19

gel-e's Life Foam Expanding Injectable Hemostat Gains Breakthrough Status

Accelerated regulatory pathway for first internal use product.

PR Newswire 06.18.19

Diagnostics | Neurological | Software & IT

FDA OKs Canon Medical's Deep Convolutional Neural Network Image Reconstruction

Advanced intelligent Clear-IQ Engine (AiCE) delivers high spatial resolution 3-5x faster than MBIR.

PR Newswire 06.18.19

Diagnostics

Bio-Techne's ExoDx Prostate IntelliScore Test Wins Breakthrough Status

ExoDx Prostate IntelliScore is the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation.

PR Newswire 06.18.19

Diagnostics | Neurological

Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts

Health Providers subscribed to the "all-in-one" AI1 package can now benefit from an additional important alert—for intracranial hemorrhage (brain bleeds).

PR Newswire 06.18.19

LENSAR Laser System Receives FDA Clearance to Perform Micro Radial Incisions

Indication allows surgeons to treat additional corneal conditions post cataract surgery.

Business Wire 06.17.19

Electronics | Software & IT | Surgical

FDA OKs MRI-Safe Cochlear Implant with Android Connectivity

Cochlear delivers Nucleus Profile Plus Implant, first cochlear implant manufacturer to enable Android direct connectivity with the Nucleus 7 Sound Processor.

PR Newswire 06.17.19

Surgical