COVID-19 has shined a spotlight on the vast potential of digital health, from pandemic response to how clinicians protect and care for patients. Now, Israel-based venture capital firm OTV has closed a $170 million fund aimed at fueling future growth in digital health technologies. In conjunction with the closing, OTV also reported that it has changed its name from Olive Tree Ventures and named Jose Antonio Urrutia Rivas as head of Asia Pacific operations.
Livanova plc has inked an agreement with Gyrus Capital SA to divest its heart valve business. The sale has an enterprise value of €60 million (US$73 million) and is expected to wrap up in the first half of next year. The Livanova board has already given its unanimous assent for the deal. Livanova now expects to strengthen its focus on its neuromodulation and cardiovascular platforms.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Caretaker Medical, Viveve.
Keeping you up to date on recent developments in diagnostics, including: Quantum nanodiamonds could improve disease detection; Field-friendly approach could aid in malaria control; Equine encephalitis’ entry elucidated.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).
With hospitalizations rapidly rising as the COVID-19 pandemic washes across the world in a winter wave, researchers are racing to develop treatments that protect the increasing number of ventilated patients. One option focuses on protecting muscles critical to breathing.
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