Motus GI Holdings Inc. received FDA 510(k) clearance to use its Pure-Vu system in upper gastrointestinal endoscopies, expanding the system’s indications from use only in colonoscopies. Pure-Vu removes blood, blood clots and debris from the GI tract, allowing endoscopists to see sources of bleeding and other issues while leaving the endoscope's working channel available for other uses.

While the founder of Woebot Health says that the app is not intended to replace human therapists, for the majority of the world who cannot locate an available psychologist or afford one once found, Woebot aims to offer a “radically accessible” option for mental health care.

Restor3d Inc. added a new dimension to its offerings with its merger with Kinos Medical Inc. The combination will increase Restor3d’s presence in the foot and ankle repair and replacement market by adding the Kinos Axiom total ankle system to its portfolio of 3D-printed implants using biomedical materials in a variety of applications.

While saying "white rabbit, white rabbit" on the first of the month may be a luck-bringing superstition, Whiterabbit.ai aims to take luck out of the equation in identifying early breast malignancies. The Santa Clara, Calif.-based company emerged from stealth mode with FDA clearance for its Wrdensity tool, two other products, and more than $49 million in funding to date.

In the last decade, responsive neurostimulation (RNS) has become a mainstay of treatment for refractory focal epilepsy, but challenges with the technology remain. Researchers at Columbia University in New York appear to have overcome some of the major limitations through development of a compact, flexible, high performance implantable device that permits reading and manipulation of brain circuits.

Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.

Avenda Health Inc. has taken a page out of the breast cancer book with a new technology that offers very localized treatment of prostate tumors in a procedure the company refers to as a prostate cancer lumpectomy. The FDA granted breakthrough device designation to the product based on its potential to transform care for one of the most common cancers.

Almost 11 years to the day after first gaining FDA clearance, the Sonarmed airway monitoring system finally launched on a commercial scale in the U.S. The new rollout appears likely to revive the product’s prospects as it comes with significantly increased financial backing and deep connections to hospitals as a result of Sonarmed’s acquisition by Medtronic plc in December 2020. The system, which uses acoustic technology to identify endotracheal tube obstruction and verify proper tube positioning in neonates and infants who require invasive mechanical ventilation, has been implemented in a small number of hospitals to date.

Across the world, rates of depression have reached alarming new heights as a result of the grief, uncertainty and isolation experienced through the pandemic. Despite the high prevalence of depression, its treatment remains a hit-or-miss affair. Up to two-thirds of patients fail to respond to the first antidepressant prescribed and many of them never return to try another. Tel Aviv-based Taliaz Ltd. has developed an artificial intelligence-driven tool to help psychiatrists and other prescribers get it right the first time.

Neuroelectrics Inc. garnered $17.5 million in a series A fundraising round led by the Morningside Group of Hong Kong. The Cambridge, Mass. and Barcelona-based brain stimulation company plans to use the funds primarily to advance its pivotal trial of the Starstim system in refractory focal epilepsy and its at-home feasibility study in refractory major depressive disorder and related infrastructure, Neuroelectrics co-founder and CEO Ana Maiques told BioWorld. Supportive infrastructures for the trials include brain modeling, the platform for remote montage delivery, and clinical and regulatory resources.