MedTech Business - October 16, 2019
OssDsign receives FDA clearance
The company has been granted 510(k) clearance by the US Food and Drug Administration (FDA) to market OssDsign Cranial PSI Accessories in the US. The cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of OssDsign’s patient specific cranioplasty implant already cleared by the FDA. The […]
MedTech Business - October 4, 2019
Coala Life launches in the US
The US market launch and first patients were initiated in collaboration with Dr. Jerome Dwyer, Cardiologist, President of St. Louis Cardiology Center, P.C., and Dr. Gil Vardi, Cardiologist, Partner at St. Louis Heart and Vascular. “The Coala is a unique and smart digital solution for diagnostics of palpitations, and suspected Atrial Fibrillation, with detection anytime, […]
MedTech Business - September 24, 2019
Dignitana receives TGA approval in Australia
The Therapeutic Goods Administration (TGA) has cleared DigniCap Delta for use by health care providers in Australia. The new device is the fourth generation of The DigniCap Scalp Cooling System and is indicated to prevent chemotherapy-induced hair loss in patients with solid tumors. “DigniCap Delta changes everything about the way scalp cooling is done today,” […]
New Market - September 23, 2019
Lundbeck and Takeda announce approval of Trintellix in Japan
The two companies jointly announced today that the MHLW of Japan approved Trintellix (vortioxetine) for the treatment of depression and depressed state. The NDA filing submitted to the MHLW in September 2018 included data from a phase III trial, which demonstrated statistically significant improvement in overall symptoms of depression in adults as compared to placebo. […]
New Market - June 30, 2019
Indian life science company establishes affiliate in Lund
The Indian consulting company, Wayinia, has opened an office in Medicon Village, the life science research park in Lund. The company aim is to help Scandinavian healthcare and medtech companies enter the Indian market and to support Indian companies that seek collaborative partners in Scandinavia. It intends to have five employees at their Swedish affiliate […]
MedTech Business - June 27, 2019
Dignitana receives FDA clearance
The United States Food and Drug Administration has cleared DigniCap Delta for use by U.S. health care providers. The new device is the fourth generation of The DigniCap Scalp Cooling System and is indicated to prevent chemotherapy-induced hair loss in patients with solid tumors. European installations of DigniCap Delta began last month after the device […]
