Stat Surgical Supply

02/18/2026

New FDA labeling changes for menopausal hormone therapy could reshape conversations around menopause treatment.

The agency has eased certain boxed warnings after reviewing newer scientific data, signaling a more nuanced approach to risk communication in women’s health. Safety information remains, but guidance now reflects updated evidence and individualized care considerations.

This shift may influence clinical decisions, patient education, and pharmaceutical market dynamics in the years ahead.

https://www.statsurgicalsupply.com/news/fda-approves-labeling-changes-for-menopausal-hormone-therapy-easing-decades-old-boxed-warnings

On February 12, 2026, the U.S. Food and Drug Administration (FDA) approved significant labeling updates for several menopausal hormone therapy (MHT) products, r...

02/16/2026

New FDA alerts are highlighting an increase in high-risk medical device recalls across several surgical and clinical categories.

From anesthesia supplies and implants to monitoring sensors and wound care products, hospitals must act quickly to identify affected inventory and maintain safe clinical workflows.

Proactive supply-chain management is becoming essential to prevent disruptions and ensure patient safety.

Discover the key implications and recommended actions for healthcare organizations in our latest update.

https://www.statsurgicalsupply.com/news/fda-flags-new-wave-of-high-risk-device-actions-what-u-s-or-supply-chains-must-do-next

02/11/2026

Artificial intelligence is reshaping modern healthcare but it also brings new challenges.

Recent reports link AI enhanced medical devices to increasing safety concerns in surgery and imaging. Experts are now calling for stronger oversight, better validation, and more careful clinical adoption to ensure patient safety remains the priority.

If you work in healthcare, medical supply, or clinical operations, this is an important development to watch.

👉 Read the full story and stay informed about how AI is changing medical technology.

https://www.statsurgicalsupply.com/news/surgeons-regulators-sound-alarm-as-ai-enhanced-medical-devices-linked-to-rising-reports-of-surgical-mishaps

Surgeons, Regulators Sound Alarm as AI-Enhanced Medical Devices Linked to Rising Reports of Surgical Mishaps A major Reuters investigation published today revea...

02/06/2026

A new milestone in breast cancer surgery is here.

Robot-assisted nipple-sparing mastectomy has now received FDA approval and is being introduced in clinical practice — offering the potential for smaller incisions, improved precision, and better cosmetic outcomes for certain patients.

But beyond the clinical benefits, this also signals how robotic technology is transforming modern surgery and hospital care.

We explain what this means for patients, hospitals, and the future of surgical innovation.

👉 Read the full story on our latest news update:
https://www.statsurgicalsupply.com/news/mayo-clinic-introduces-fda-approved-robotic-nipple-sparing-mastectomy-a-milestone-in-breast-surgery-innovation

January 2026 — United States Mayo Clinic has begun offering a newly FDA-approved robot-assisted nipple-sparing mastectomy (RNSM), marking a significant advancem...

02/04/2026

🦾 Surgical robots are getting more portable.

Stryker has started clinical use of a handheld robotic tool within its Mako platform — designed to bring robotic precision to more orthopedic procedures without the footprint of large systems.

This could open the door for:
✔ More hospitals and ASCs to adopt robotics
✔ Faster OR setup and workflow flexibility
✔ Expanded access to precision joint surgery

The shift toward smaller, smarter robotic tools is changing how orthopedic care is delivered.

👉 Read the full story and what it means for hospitals:
https://www.statsurgicalsupply.com/news/stryker-introduces-handheld-orthopedic-robotic-tool-in-clinical-settings-as-adoption-grows

January 30, 2026 — United States — Stryker Corporation, a major global player in orthopedics and surgical technologies, has begun clinical use of a newly develo...

01/16/2026

Please note that our offices will be closed on Monday, January 19th in observance of Martin Luther King Jr. Day.

We want to take this moment to thank our customers, partners, and team for your continued trust and collaboration.

We look forward to connecting with you later in the week.

01/09/2026

🩹 New FDA-Cleared Option for Treating Complex Wounds

The FDA has cleared Theracor™, a new wound care device made from human umbilical cord tissue, designed to support healing in difficult wounds.

Unlike traditional dressings, Theracor™ comes in a sheet format that provides continuous coverage — making it useful for surgical wounds, diabetic ulcers, pressure injuries, and trauma-related skin damage.

This approval expands treatment options for clinicians and may help improve outcomes for patients with chronic or hard-to-heal wounds.

👉 Learn more about what this FDA clearance means: https://www.statsurgicalsupply.com/news/fda-clears-theracor-t-m-first-human-umbilical-cord-derived-wound-care-sheet-device-expanding-options-for-complex-wounds

December 29, 2025 — United States The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Theracor™, a next-generation wound care medical d

01/08/2026

🤖 Big News in Robotic Surgery

The FDA has cleared Medtronic’s Hugo™ robotic surgery system for urologic procedures in the U.S. — marking the first major new competitor to existing robotic platforms in years.

Hospitals and surgery centers may now have more options when expanding robotic programs, potentially improving access, flexibility, and cost dynamics.

Learn what this means for surgeons, hospitals, and the future of robotic-assisted surgery:
👉 https://www.statsurgicalsupply.com/news/medtronic-s-hugo-t-m-surgical-robot-gains-fda-clearance-reshaping-the-u-s-robotic-surgery-market

Medtronic has reached a major regulatory milestone with the U.S. Food and Drug Administration (FDA) clearance of its Hugo™ Robotic-Assisted Surgery (RAS) system

12/22/2025

🌍 Advancing Women’s Health Through Global Collaboration

Mount Sinai has joined the Milken Institute’s Women’s Health Network, a global effort to strengthen research, innovation, and equity in women’s health.

This partnership aims to close gaps in care, improve outcomes, and elevate women’s health as a priority across medicine and policy.

Learn more about what this collaboration means:
https://www.statsurgicalsupply.com/news/icahn-school-of-medicine-at-mount-sinai-joins-milken-institute-s-women-s-health-network-strengthening-global-efforts-in-women-s-health-research-and-care

December 15, 2025 — New York, NY — The Icahn School of Medicine at Mount Sinai has been named an official member of the Milken Institute’s Women’s Health Networ

12/16/2025

🩺 FDA Clears New Technology to Improve Breast Cancer Surgery

The FDA has cleared MarginProbe® 2, a surgical tool that helps doctors detect cancer-positive margins during breast-conserving surgery — potentially reducing the need for repeat operations.

This technology gives surgeons real-time feedback in the operating room, helping improve precision and patient outcomes.

Learn how MarginProbe® 2 could change lumpectomy procedures and hospital workflows: https://www.statsurgicalsupply.com/news/dilon-technologies-secures-fda-approval-and-u-s-launch-of-marginorobe-advancing-intraoperative-margin-assessment-in-breast-conserving-surgery

December 15, 2025 — United States Dilon Technologies has received U.S. Food and Drug Administration (FDA) clearance for its MarginProbe® 2 system and officially

12/01/2025

⚠️ Medline Sterile Kit Recall Still Active, FDA Confirms

The FDA has announced that the recall affecting several Medline sterile surgical convenience kits is still active — and cannot be closed until Medline submits its final documentation.

No injuries have been reported, but using a non-sterile kit in surgery can lead to serious infections or complications.

If your facility uses Medline kits, be sure to:
➡️ Check inventory for the affected model numbers
➡️ Remove impacted kits immediately
➡️ Follow Medline’s return instructions
➡️ Notify your surgical and clinical teams

Read the full update here: https://www.statsurgicalsupply.com/news/medline-recall-of-sterile-convenience-kits-remains-active-as-fda-awaits-final-disposition-report

November 24, 2025 — United States. The U.S. Food and Drug Administration (FDA) has confirmed that the recall involving several sterile surgical convenience kits

11/26/2025

⚠️ FDA Issues Urgent Safety Alert for Siemens 3T MRI Systems

Several Siemens 3-Tesla MRI models may have blocked helium venting pathways — a serious issue that could cause pressure buildup or dangerous gas release during a magnet “quench.”

Siemens has issued urgent instructions:
• Remove patients immediately if the warning appears
• Do NOT reboot the scanner
• Secure and restrict access to the MRI room
• Keep emergency exits clear
• Schedule a mandatory service inspection
• Notify all imaging and clinical staff

Although the scanners may continue to operate under strict conditions, hospitals must act quickly to prevent potential harm.

👉 Read the complete breakdown: https://www.statsurgicalsupply.com/news/siemens-healthineers-faces-class-1-safety-correction-for-3-tesla-mri-systems-what-hospitals-and-imaging-departments-must-do

On November 19, 2025, the U.S. Food and Drug Administration (FDA) released an alert titled “Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI System