Healthcare Press Releases

Hyperfine, Inc. the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced FDA clearance of its most significant technological advancement to date. The clearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™ software.

GE HealthCare announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer.

Atia Vision, Inc., a Shifamed portfolio company, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a traditional feasibility clinical study of its OmniVu™ Lens System. This novel intraocular lens is designed to restore dynamic range of vision following cataract surgery, going beyond the capabilities of current presbyopia-correcting lenses.

Stryker a global leader in medical technologies, announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) received 510(k) clearance from the U.S. Food and Drug Administration. OptaBlate BVNA is used in a targeted minimally invasive procedure providing long-lasting† vertebrogenic pain relief1.

Boston Scientific Corporation announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and adjunctive use of the FARAPOINT™ PFA Catheter in patients with persistent atrial fibrillation (AF).  Key findings from the study were presented at the second annual PFA Live Case Summit in San Diego and simultaneously published in Circulation.

SonoMotion, a medical device company developing noninvasive solutions for kidney stones, announced it has been awarded a $2.2 million NIH grant and successfully completed patient enrollment in the SOUND Break Wave pivotal clinical trial.

Medline UNITE, a leader in the foot and ankle surgery market, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest implant family, the REFLEX® HYBRID Nitinol Implant System. 

SWS Medical, a leading blood purification solution provider in China. For over two decades, SWS has cemented itself as a key player in dialysis, exporting to over 80 countries and securing 200 patents. It leads domestic dialysis machine brands in China with a 15.9% market share in 2024, rising to 27.11% in Feb 2025.

4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary TRUSS Implant Technology™, announced that the company has surpassed the 100,000 spine procedure milestone, showing widespread adoption due to the technology's unique benefits. 4WEB has the distinction of being the first company to achieve 510(k) clearance for a spine implant manufactured with 3D printing technology.

Exactech, a global medical technology leader, announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent 12,239,384, further expanding its intellectual property portfolio around the Newton® soft tissue balancing technology. This newly granted patent originates from a series of dedicated patent applications that enable the software-driven evolution of the Newton technology, marking a significant advancement toward autonomous, personalized surgical planning.