Glaukos Corp. reported 12-month results from the pivotal IDE trial of its Istent Infinite trabecular micro-bypass system, showing substantial reduction in mean diurnal intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medication. The company is targeting U.S. FDA approval of the device for standalone moderate-to-severe glaucoma in late 2021.

Neuros Medical Inc., a company developing neuromodulation technology to treat intractable post-amputation pain, has raised $38.5 million in a series BB financing. The funds will be used to complete enrollment in its pivotal QUEST clinical trial and to submit a premarket approval application to the U.S. FDA. New investors Amzak Health and Sectoral Asset Management co-led the round.

With uncertainty continuing to surround the ongoing pandemic, Biointellisense Inc. has revealed that it is teaming up with the American College of Cardiology (ACC) to advance remote patient monitoring programs for cardiac care. In addition, the ACC plans to offer the company's Biobutton COVID-19 Screening Solution at the 70th Annual Scientific Session & Expo, scheduled for May 15-17 in Atlanta.

Much of the noise surrounding transcatheter aortic valve replacement (TAVR) vs. its surgical counterpart has to do with residual paravalvular leak. However, a new paper in the Journal of the American College of Cardiology (JACC) seems to have overwritten that consideration. The underlying registry study indicates that procedural success and outcomes at one year are superior in TAVR to in SAVR – yet another piece of evidence that seemingly tips the scales even more toward TAVR devices.

A new imaging technology that uses transmission ultrasound to provide a 3D image of breast tissue outperformed traditional digital mammography in a recent retrospective analysis. The study findings could set the stage for the U.S. FDA to clear the technology for breast cancer screening in young, high-risk women.

Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical.

A new $23 million in funds gives Brainbox Solutions Inc. a head start as it begins enrollment in the pivotal clinical trial of its mild traumatic brain injury (TBI) diagnostic and prognostic test. Bioventures Investors took the lead in the series A financing. The Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, and Astia Angels participated in the fundraising round along with qualified investors including the Cleveland Cavaliers' Kevin Love, a mental health advocate.

Emboline Inc., which is developing technology to reduce the chance of stroke during transcatheter heart procedures, completed a $10 million series C financing. The funds are earmarked to gain initial commercial approval of the company’s Emboliner device and to launch a U.S. pivotal study. The round, which included new and existing investors, follows a $5 million bridge round of financing that closed last January.

Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.

While several companies are looking to help recurrent glioblastoma patients, Carthera SAS has taken a step forward by bringing its Sonocloud-9 device into a phase I/II clinical trial. Northwestern University in Chicago will collaborate with the company in the trial, which is expected to enroll up to 39 patients. The first patient already has been treated.