Concept Medical Granted “Breakthrough Device Designation” by FDA for MagicTouch PTA Sirolimus Coated Balloon

Posted in Medical Device by Medtech[y] Staff

August 13, 2019 • 2 min read

​Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK)....

Janssen Announces European Commission Approval of Imbruvica▼(ibrutinib) for Expanded Use in Two Indications

Posted in Biotech by Medtech[y] Staff

August 13, 2019 • 2 min read

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has approved variations to broaden the use of Imbruvica® (ibrutinib) in two indications. This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia...

Georgia-based Hamilton Health Care System First in U.S. to Use New Baxter Technology in the ICU

Posted in Medical Device and Hospitals by Medtech[y] Staff

August 13, 2019 • 2 min read

Hamilton Health Care System, a top 10% national hospital provider in overall health care according to CareChex® medical quality ratings, and Baxter International Inc. (NYSE:BAX), a global leader in acute care, today announced that Hamilton is the first health system in the U.S. to use Baxter’s new PrisMax system...

Zip Surgical Skin Closure Demonstrates Superior Health Economics and Clinical Outcomes Compared to Surgical Staples in Two Recently Published Clinical Studies

Posted in Medical Device by Medtech[y] Staff

August 13, 2019 • 2 min read

ZipLine Medical, Inc. today announced publication of positive results from two significant clinical studies in two peer-reviewed journals demonstrating that use of Zip® Surgical Skin Closure leads to better clinical outcomes and healthcare cost savings than do surgical staples....