Home » Topics » Medical Devices » Submissions and Approvals

Submissions and Approvals
RSS

VivaLNK Wearable ECG Sensor Platform Cleared

January 24, 2020

The software development kit also integrates with the previously cleared VivaLNK temperature sensor. Read More

STRATA Gains 510(k) Clearance for XTRAC Momentum Laser Platform

January 23, 2020

The new platform includes an increased power range and an enhanced database for managing patient information. Read More

AIROS Compression Device Cleared for Breast Cancer Patients

January 22, 2020

The compression device is also available for use with leg and arm garments. Read More

SoundBite System Nabs 510(k) Clearance

January 22, 2020

The company plans to launch the product in the U.S. market for treatment of “patients suffering from difficult-to-treat calcific peripheral artery disease.” Read More

RA Medical Receives Investigational Device Exemption

January 21, 2020

The multicenter trial will enroll up to 100 patients. Read More

Axonics Programmer Nabs Premarket Approval

January 21, 2020

The wireless system reduces surgery time and simplifies post-implant device programming. Read More

FDA Schedules Workshop on Virtual and Augmented Reality in Medicine

January 20, 2020

The agency aims to promote development of evaluation techniques for extended reality devices. Read More

FDA Calls on Duodenoscope Makers to Shift to Newer Designs

January 16, 2020

The agency cleared the first fully disposable duodenoscope in December. Read More

Pentax Medical Nabs FDA Clearance for Endoscopy Platform

January 16, 2020

The device features LED lights that eliminate the need for periodic bulb replacements. Read More

TransEnterix Files 510(k) Submission for Senhance Surgical System Addition

January 16, 2020

The addon would improve the system’s eye-tracking camera control. Read More

FDA Clears BioCardia’s Guide Catheter for Biotherapeutic Delivery System

January 16, 2020

The guide catheter improves the use of the Helix system while cell therapy is being delivered. Read More

Cleveland Clinics’ Patient-Specific Airway Stents Cleared

January 15, 2020

The company said its airway stents “have the potential to be more tolerable than traditional silicone stents.” Read More

Upcoming Events

New!

17th Medical Device Quality Congress

Learn More Here

Submissions and Approvals
RSS

VivaLNK Wearable ECG Sensor Platform Cleared

STRATA Gains 510(k) Clearance for XTRAC Momentum Laser Platform

AIROS Compression Device Cleared for Breast Cancer Patients

SoundBite System Nabs 510(k) Clearance

RA Medical Receives Investigational Device Exemption

Axonics Programmer Nabs Premarket Approval

FDA Schedules Workshop on Virtual and Augmented Reality in Medicine

FDA Calls on Duodenoscope Makers to Shift to Newer Designs

Pentax Medical Nabs FDA Clearance for Endoscopy Platform

TransEnterix Files 510(k) Submission for Senhance Surgical System Addition

FDA Clears BioCardia’s Guide Catheter for Biotherapeutic Delivery System

Cleveland Clinics’ Patient-Specific Airway Stents Cleared

Upcoming Events

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

SOPs and Policies for the 21st Century: Why Less is More

17th Annual Medical Device Quality Congress

Featured Products

Biological Risk Evaluation and Management for Medical Devices

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

CDER Launches Program to Tackle Controlled Substance Abuse

Dexcom’s Continuous Glucose Monitoring System Grabs CE Mark

Janssen to Work with HHS on Coronavirus Vaccine, Vows to Manufacture It

Canon Receives 510(k) Clearance for AI-Assisted CT System

New!

17th Medical Device Quality Congress

Submissions and Approvals RSS

New!

17th Medical Device Quality Congress

Submissions and Approvals
RSS