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...