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. Read More
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. Read More
Of all the things that irritate physicians about health insurance, prior authorization might be at the top of the list. That didn’t stop the U.S. Centers for Medicare & Medicaid Service (CMS) from imposing a prior authorization requirement for the implant of spinal stimulators and for cervical fusion with disc removal in the calendar year 2021 Medicare outpatient prospective payment system, however. Read More
For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes. Read More
PARIS – Researchers at the Biomechanics and Bioengineering laboratory (BMBI), a joint venture between the Compiègne University of Technology in Oise, France, and the National Center for Scientific Research (CNRS), have designed a new implant intended for minimally invasive surgery for mitral valve repair. One of the BMBI teams has been working closely two cardiovascular surgeons from the University Hospital of Henri-Mondor to develop this new minimally invasive approach in the treatment of mitral valve regurgitation. Read More
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. Read More
Med-tech firms raising money in public or private financings, including: Everlywell, Ortho Regenerative Technologies, Progenity, Rewalk Robotics, Single Technologies, Virta Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Caretaker Medical, Viveve. Read More
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. Read More
