FDA Clears BrainSpace Intellidrop, an automated neuro device that addresses ICU nursing shortages and builds training data for Physical AI
SEATTLE, Jan. 2, 2026 /PRNewswire/ — BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop, an automated brain fluid... Read More →
Nitinotes Announces First Patient Treated in Pivotal EASE™ Clinical Trial Evaluating the EndoZip™ Automated Suturing System for ESG
CAESAREA, Israel, Dec. 10, 2025 /PRNewswire/ — Nitinotes Ltd., an early commercial stage medical technology company developing fully automated endoluminal suturing solutions for obesity treatment, today announced that the first patient has been treated in its U.S. Investigational Device Exemption... Read More →
Breast Cancer Survivor Finally Heals With BLOOM⁴³
Patient Stories: How MedTech Innovator alumni are transforming lives At MedTech Innovator, we empower healthtech companies to bring groundbreaking solutions to patients in need. Our Patient Stories series highlights the real-world clinical impact of the companies we support—showcasing how their... Read More →
Moon Surgical adds 5G and Wi-Fi to Maestro robots for cloud-based AI
Targeting a soft-tissue market led by Intuitive Surgical, Moon has invested in digital capabilities to try to differentiate its robots from the competition. AI hardware leader Nvidia co-led Moon’s $55.4 million financing round in 2023. Moon received Food and Drug... Read More →
NeuroBionics Announces Oversubscribed $10M Seed Round with Second Close Led by Future Ventures
Financing strengthens momentum as the company advances its endovascular neuromodulation platform toward first-in-human studies. NeuroBionics today announced the completion of its oversubscribed seed round, marking significant momentum as the company advances its endovascular neuromodulation platform toward first-in-human studies. The second... Read More →
AeviceMD Achieves Australia TGA Certification
Singapore, 16 Dec 2025 — AeviceMD Monitoring System, a non-invasive wearable respiratory monitoring solution developed by Aevice Health, has been included in the Australian Register of Therapeutic Goods (ARTG) as a Class IIa medical device. This milestone marks an important... Read More →
RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit
CHARLOTTESVILLE, Va., Dec. 16, 2025 /PRNewswire/ — RIVANNA®, developer of world-first imaging-based medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Accuro® 3S Needle Guide Kit consumables. This clearance marks a... Read More →
Teal Health Partners with Thatch Marketplace to Increase Employee Access to At-Home Cervical Cancer Screening
SAN FRANCISCO, Dec. 16, 2025 /PRNewswire/ — Teal Health, a virtual women’s health platform and the creators of the first and only FDA-authorized self-collection device for at-home cervical cancer screening, today announced the availability of their services on the Thatch... Read More →
Leucid Bio and Syenex Announce Strategic Collaboration for In Vivo CAR-T Cell Engineering
London, UK and Chicago, IL – 15 December 2025 – Leucid Bio (“Leucid” or the “Company”), a privately-held biotechnology company developing innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using its proprietary lateral CAR platform, and Syenex, an open-science genetic medicines... Read More →
FDA Approves the Zenflow Spring® Implant and Delivery System for First-Line Interventional Therapy of Patients with Benign Prostatic Hyperplasia (BPH)
Long-Term Data Supports Three-Year Durability Innovative Design Allows for Only Tailored BPH Approach that Preserves Natural Anatomy SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Zenflow, Inc. announced today the U.S. Food and Drug Administration (FDA) approval of... Read More →