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🌍 Advancing Women’s Health Through Global CollaborationMount Sinai has joined the Milken Institute’s Women’s Health Netw...
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

🩺 FDA Clears New Technology to Improve Breast Cancer SurgeryThe FDA has cleared MarginProbe® 2, a surgical tool that hel...
12/16/2025

đź©ş 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

⚠️ Medline Sterile Kit Recall Still Active, FDA ConfirmsThe FDA has announced that the recall affecting several Medline ...
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

⚠️ FDA Issues Urgent Safety Alert for Siemens 3T MRI SystemsSeveral Siemens 3-Tesla MRI models may have blocked helium v...
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

🔥 New Weight-Loss Drug Shows Up to 20% Reduction in Phase 2!Eli Lilly’s new drug eloralintide has delivered impressive r...
11/20/2025

🔥 New Weight-Loss Drug Shows Up to 20% Reduction in Phase 2!

Eli Lilly’s new drug eloralintide has delivered impressive results — up to 20.1% weight loss at 48 weeks in a major Phase 2 trial. This could be a breakthrough option for people who don’t respond well to GLP-1 medications.

Key highlights:
âś” Weekly injections
âś” Multiple dose options
âś” Strong dose-response
âś” Tolerability improves with slower escalation
âś” Phase 3 trials starting soon

Hospitals, clinics, and obesity specialists are already preparing for what this could mean in 2026.

👉 Full story here: https://www.statsurgicalsupply.com/news/eloralintide-shows-up-to-20-1-weight-loss-in-phase-2-trial-what-this-means-for-the-future-of-obesity-treatment

November 2025 — In a major step forward for obesity therapeutics, Eli Lilly and Company has reported highly positive Phase 2 results for eloralintide, a once-we

Major Update in Robotic Knee Surgery!The FDA has officially cleared Zimmer Biomet’s ROSA® Knee with OptimiZe™, bringing ...
11/19/2025

Major Update in Robotic Knee Surgery!
The FDA has officially cleared Zimmer Biomet’s ROSA® Knee with OptimiZe™, bringing new precision and personalization to total knee replacement procedures.

This upgraded robotic system helps surgeons improve implant alignment, streamline workflow, and personalize the surgery to each patient — potentially improving recovery and long-term outcomes.

Hospitals and surgical centers may see big changes in:
🏥 OR integration
📦 Supply-chain planning
🦴 Orthopedic surgery workflows
🧑‍⚕️ Surgeon personalization & efficiency

👉 Read the full breakdown of what this means for orthopedic care and hospital operations: https://www.statsurgicalsupply.com/news/zimmer-biomet-s-rosa-knee-with-optimize-gains-fda-clearance-promises-next-level-surgical-personalization

Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of its R

🚨 FDA Issues Critical Labeling Update for Olympus BronchoscopesOlympus has released new global safety labeling after rep...
11/13/2025

🚨 FDA Issues Critical Labeling Update for Olympus Bronchoscopes
Olympus has released new global safety labeling after reports of endobronchial combustion linked to laser therapy, APC, and cautery during bronchoscopy — including at least one fatal case.

Hospitals, ASCs, and pulmonary teams must now:
âś” Review affected bronchoscope models
âś” Update staff training
âś” Ensure all revised labeling is implemented across units
âś” Reassess energy-device use in high-oxygen environments

This update isn’t just procedural — it impacts patient safety, device workflows, and compliance across pulmonary and surgical services.

👉 Read the full analysis here: https://www.statsurgicalsupply.com/news/olympus-issues-voluntary-labeling-update-for-bronchoscopes-following-endobronchial-combustion-repors

Olympus Corporation has issued a voluntary global labeling update for several of its bronchoscopic devices following serious safety concerns, including reports

🚨 FDA Issues Warning Letter to Philips Over Quality System DeficienciesThe FDA has formally cited Philips for regulatory...
11/10/2025

🚨 FDA Issues Warning Letter to Philips Over Quality System Deficiencies
The FDA has formally cited Philips for regulatory noncompliance across three manufacturing sites in the U.S. and Europe, following major inspections revealing quality-system regulation (QSR) violations.

🏥 Why this matters:
➡️ Hospitals and surgical centers must review procurement and service contracts involving Philips imaging, monitoring, and surgical devices.
➡️ Biomedical and supply-chain teams should prepare for potential supply disruptions, service delays, or part shortages.
➡️ Vendor compliance now directly affects clinical continuity and operational safety.

đź“– Read what your hospital should do next to stay ahead of vendor risk: https://www.statsurgicalsupply.com/news/fda-issues-warning-letter-to-philips-facilities-a-supply-chain-alert-for-surgical-and-imaging-procurement

October 28, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has issued a formal warning letter to Philips following inspections at three of

💊 FDA Approves Revumenib for NPM1-Mutated AMLThe FDA has officially approved revumenib (Revuforj®) for adults and childr...
11/04/2025

đź’Š FDA Approves Revumenib for NPM1-Mutated AML
The FDA has officially approved revumenib (Revuforj®) for adults and children (≥1 year) with relapsed or refractory AML carrying an NPM1 mutation.

🏥 Why it matters:
➡️ Expands menin-inhibitor therapy to a new AML subgroup
➡️ Triggers major planning for hospital pharmacies and oncology supply chains
➡️ Requires updated formulary, procurement, and reimbursement protocols

👉 Read how hospitals, oncology centers, and procurement teams can prepare: https://www.statsurgicalsupply.com/news/fda-grants-approval-to-revumenib-for-npm1-mutated-relapsed-refractory-aml-what-hospitals-and-supply-chains-must-prepare-for

FDA Grants Approval to Revumenib for NPM1-Mutated Relapsed/Refractory AML — What Hospitals and Supply Chains Must Prepare For October 24, 2025 — Washington, D.C

⚠️ FDA Recalls ICU Medical and Philips Devices — Operational Impact AlertThe FDA has announced two major Class II recall...
10/31/2025

⚠️ FDA Recalls ICU Medical and Philips Devices — Operational Impact Alert
The FDA has announced two major Class II recalls affecting:
🧪 ICU Medical’s ChemoLock Vial Spikes (20 mm) — risk of leaks and contamination during chemotherapy preparation.
🩻 Philips CT 5300 scanners — software malfunction that can cause image misregistration or system freezing.

These recalls affect oncology infusion and intraoperative imaging services nationwide.
Hospitals and surgical centers should audit inventories, isolate affected lots, and coordinate corrective actions with the manufacturers immediately.

👉 Full details and hospital action plan: https://www.statsurgicalsupply.com/news/fda-issues-recalls-for-icu-medical-and-philips-devices-critical-impact-on-surgical-and-Imaging-operations

October 27, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has posted multiple Class II medical device recalls affecting widely used surgic

⚙️ FDA Raises the Bar for Medical Device SafetyThe FDA is tightening expectations on biocompatibility and particulate co...
10/24/2025

⚙️ FDA Raises the Bar for Medical Device Safety
The FDA is tightening expectations on biocompatibility and particulate control for implantable and intravascular devices, following updates to ISO 10993-1 and increased scrutiny of particulate contamination.

đź’ˇ Why it matters:
➡️ Manufacturers must provide new, risk-based biocompatibility justifications.
➡️ Hospitals and procurement teams must verify supplier controls.
➡️ Particulate testing and traceability are now critical for regulatory readiness.

👉 Read the full breakdown and checklist for compliance: https://www.statsurgicalsupply.com/news/fda-tightens-biocompatibility-and-particulate-expectations-what-device-makers-and-hospitals-must-do-now

October 14, 2025 The U.S. Food and Drug Administration (FDA) is signaling a step-change in how it evaluates medical devices—particularly on biocompatibility (IS

⚠️ FDA Issues Safety Warning on RF Microneedling DevicesThe FDA has released a public safety communication after receivi...
10/23/2025

⚠️ FDA Issues Safety Warning on RF Microneedling Devices
The FDA has released a public safety communication after receiving multiple reports of serious injuries related to radiofrequency (RF) microneedling systems, including burns, scarring, and nerve damage.

While these devices are mainly used for aesthetic skin treatments, the warning highlights new implications for hospitals and surgical centers, where complications may require surgical repair.

👉 Read the full story and see the FDA’s recommendations for hospitals, procurement teams, and clinicians: https://www.statsurgicalsupply.com/news/fda-issues-safety-warning-on-rf-microneedling-devices-surgical-risk-signals-new-procurement-imperatives

FDA Issues Safety Warning on RF Microneedling Devices: Surgical Risk Signals New Procurement Imperatives October 15, 2025 The U.S. Food and Drug Administration

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