Cardiac Dimensions Inc. launched the Empower trial of its Carillon mitral contour system for the treatment of heart failure patients with early-stage functional mitral regurgitation. The company expects to enroll up to 300 patients at 75 sites in the international, randomized, sham-controlled trial.
Jorge Ulloa of Hancock Jaffe Laboratories Inc. presented positive results from a first-in-human trial of implantation with its Venovalve device at the Society for Vascular Surgery annual meeting in San Diego. Two years following surgery, outcomes included more than 60% improvements in reflux and disease manifestations and 93% decrease in pain in patients with chronic venous insufficiency with no safety issues or venous ulcer recurrences.
Verily Life Sciences LLC, a division of Alphabet Inc., took its first major step to fulfill its goal of transforming clinical trials with the announcement of an agreement to buy Signalpath LLC for an undisclosed sum. The deal is Verily’s first major acquisition since the company spun out of Google Inc. in 2015. It’s likely not the last deal for the company in the short-term, however, as it raised $700 million in December 2020 to fund its aggressive expansion plans.
Opya Inc., a provider of integrated autism services, secured $15.4 million in a series A fundraising round. New investors in the round included Panoramic Ventures, Softbank’s Opportunity Fund, Disability Opportunity Fund, and Raven One Ventures. Divergent Investments and Altitude Ventures added to their existing investments in the company.
Using a minimally invasive brain implant, Feinstein Institutes for Medical Research scientists produced tingling sensations in the fingers of patients who lacked the sense of touch as a result of nerve damage, according to a study published in Brain Stimulation. A second study by the team, which appeared in Frontiers in Neuroscience, used stereoelectroencephalography (SEEG) electrodes to decode neural signals to improve the hand control algorithms in brain-computer interfaces.
Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder to treat people with atrial fibrillation who are at risk of ischemic stroke about a month earlier than generally expected, given the backlog at the FDA. The dual-closure device closes the left atrial appendage during the procedure, reducing the risk of blood clots immediately and eliminating the need for blood thinners both during the healing process and longer term.
Memic Innovative Surgery Ltd. agreed to combine with Medtech Acquisition Corp. in a transaction expected to close in the fourth quarter of 2021. The deal establishes an eye-popping $1 billion pro forma valuation for the company, which received FDA clearance for its first device just four months ago.
While the increased use of virtual appointments has made care more accessible for many people during the pandemic, it has created challenges for providers who often lack a means to gather basic health data from patients. Advanced Human Imaging Ltd. (AHI), formerly Myfiziq Ltd., tackled the problem with a scanning technology that eliminates the need for basic vital sign equipment during telehealth visits by calculating blood pressure, heart and respiratory rate, and body mass index with a quick scan performed on a smartphone or webcam.
A less controversial option than aducanumab may be available soon to help individuals with mild to moderate Alzheimer’s disease-related dementia. Researchers at the Medical University of Vienna and the University of Toronto have developed a technique using ultrasound that reverses cognitive decline and they say it could be available for clinical use shortly.
Auctus Surgical Inc. took another step toward straightening out one of the most vexing problems in pediatric scoliosis with the announcement of FDA breakthrough device designation for its vertebral tethering system. The system offers a non-surgical option to correct spinal curvature without use of fusion or braces and its dynamic magnetic technology enables adjustment as a child grows, avoiding the overcorrection that plagues the only other tethering system currently available.