FDA Approves First Continuous Glucose Monitoring System with Fully Implantable Glucose Sensor & Compatible Mobile App The U.S. Food and Drug Administration approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days. The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor regularly...

Itamar Medical Ltd., an industry leading company that develops, manufactures, and markets sleep apnea management solutions with focus on the cardiology market, announced the launch of SleePath, the first integrated e-health sleep apnea care pathway monitoring system that allows cardiologists to monitor patients with atrial fibrillation (AF) sleep apnea management status and compliance with continuous positive airway pressure (CPAP) devices on demand. Effective management of sleep apnea is essential for improving outcomes in patients with AF, a type of irregular heartbeat that affects 6 million individuals in the United States. Sleep apnea occurs in roughly...

Australian stem cell and regenerative medicine company Cynata Therapeutics Limited is pleased to announce that it has received positive data demonstrating the efficacy of its Cymerus™ mesenchymal stem cells (MSCs) in a preclinical model of diabetic wounds (also known as diabetic ulcers). The studies were conducted independently by the Cooperative Research Centre for Cell Therapy Manufacturing (CTM CRC) and were designed to compare cells from various sources. Key Highlights: – Cymerus MSCs resulted in...

Caresyntax, a surgical data, analytics and automation company, announced it has successfully concluded its first funding round with a total of $31.9 million in collected funds. Norgine Ventures, a European business supporting innovative healthcare companies with debt-like financing, provided caresyntax with financing of up to €10 million ($11.9 million), and surgical.AI, a Berlin and Boston-based specialized healthcare artificial intelligence (AI) investor, invested $20 million. Caresyntax will use this financing to ...

In a new series of reports by iData Research, it was revealed that in 2017, the U.S. immunology market was valued at over $34 billion. A major portion of this revenue came from the biologic Humira, which accounted for over one-third of the total market value. Humira is one of the most expensive biotherapies on the market, with a typical patient cost between $1,100 and $2,600 per month. The actual drug, marketed under the brand name Humira, is called adalimumab, and was originally...

Johnson & Johnson has received an offer for its sterilization unit. The New Brunswick, NJ-based company said Fortive is seeking to acquire the business for $2.7 billion. The sterilization business is part of the Ethicon division and earned about $775 million in sales in 2017. J&J has 120 days to accept the offer and if the deal goes through it could close no later than early 2019. Fortive said it would finance the acquisition through debt or equity and with available cash. The company said it expects the deal to add to adjusted earnings in the first...