What you might have missed
Here are some of the latest news from the world of health.
FDA Recalls ICU Medical ChemoLock Vial Spikes and Philips CT 5300 Scanners Over Safety Risks, Impacting Oncology and Surgical 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 surgical consumables and diagnostic imaging systems. The recalls, announced on October 27, 2025,...
FDA Tightens Biocompatibility and Particulate Standards for Medical Devices, Raising Compliance Demands for Manufacturers and Hospitals
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 (ISO 10993-1) and particulate control for implantable and intravascular products. Industry re...
FDA Warns of Severe Injuries Linked to RF Microneedling Devices, Urging Hospitals to Strengthen Procurement and Training Protocols
FDA Issues Safety Warning on RF Microneedling Devices: Surgical Risk Signals New Procurement Imperatives October 15, 2025 The U.S. Food and Drug Administration (FDA) issued a public Safety Communication on October 15, 2025, warning of serious compli...
FDA Issues Class I Cybersecurity Correction for Abiomed Impella Controllers to Prevent Unauthorized Access Risks
October 10, 2025 The U.S. Food and Drug Administration (FDA) has issued a cybersecurity correction notice involving specific models of Abiomed’s Automated Impella Controllers (AICs) after identifying vulnerabilities that could allow unauthorized acc...
Trividia Health Recalls TRUE METRIX® Blood Glucose Meters Due to Display Defect Affecting Reading Accuracy
October 7, 2025 Trividia Health, Inc. has initiated a voluntary recall of a limited number of its TRUE METRIX® self-monitoring blood glucose meters after detecting potential defects in their LCD displays that could impair accurate reading. The recall...
FDA Opens Public Consultation on Oversight of AI-Enabled Medical Devices, Seeking Input on Real-World Performance and Safety
October 6, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has launched a formal public consultation to gather feedback on how artificial intelligence-enabled medical devices (AIMDs) should be monitored and evaluated across their ...
Biomea Fusion’s Icovamenib Shows Promising Mid-Stage Results in Type 2 Diabetes, Offering Hope for GLP-1 Nonresponders
October 6, 2025 Biomea Fusion, a clinical-stage biotechnology company, has unveiled encouraging mid-stage data for its investigational compound icovamenib (BMF-219), particularly in patients with type 2 diabetes who appear to be less responsive to G...
FDA Expands Medical Device Recall Alerts to All Devices, Urging Hospitals and Manufacturers to Strengthen Safety Systems
September 29, 2025 | Silver Spring, MD — The U.S. Food and Drug Administration (FDA) announced today a major regulatory shift that broadens its Medical Device Recall Communications Program to include all classes of medical devices, effective immediat...
OLYMPUS ISSUES GLOBAL RECALL OF VIZISHOT 2 FLEX NEEDLES AFTER PATIENT DEATH: CRITICAL ALERT FOR PULMONARY AND SURGICAL TEAMS
OLYMPUS ISSUES GLOBAL RECALL OF VIZISHOT 2 FLEX NEEDLES AFTER PATIENT DEATH: CRITICAL ALERT FOR PULMONARY AND SURGICAL TEAMS September 29, 2025 | Washington, D.C. — Olympus Corporation has announced a voluntary global recall of specific lots of its V...
FDA Issues Early Alert on Medline Kits Containing Recalled Medtronic Cardiac Cannulas
Potential Cross-Distribution Risk Raises Concerns in Cardiac Surgery Supply Chain The U.S. Food and Drug Administration (FDA) has issued an early safety alert dated September 16, 2025, warning that certain Medline surgical kits may inadvertently cont...
FDA Issues Nationwide Recall of Frontier Devices’ 14 mm Distraction Pins Over Unvalidated Shelf Life
Folsom Metal Products Faces Class II Recall Affecting Orthopedic Device Distribution Across 9 States The U.S. Food and Drug Administration (FDA) has issued a Class II device recall concerning a widely distributed orthopedic surgical tool: the 14 mm D...
FDA Issues Urgent Class I Recall of Boston Scientific Defibrillation Leads After Reports of Deaths and Serious Injuries
September 15, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most serious type of safety notice, for a series of Boston Scientific defibrillation leads used in implantable cardioverter defibrillat...
FDA Issues Correction for Tandem Diabetes Care t:slim X2 Insulin Pumps Over Speaker Wiring Defect
September 15, 2025 — Washington, D.C. The U.S. Food and Drug Administration (FDA) has announced a Class II device correction for the t:slim X2 insulin pump, a widely used device manufactured by Tandem Diabetes Care. The action follows reports of impr...
Body Contouring Boom: Drugs Are Reshaping Aesthetic Surgery Demand
September 2025 – The rapid rise of GLP-1 receptor agonists, including Ozempic (semaglutide), Wegovy (semaglutide), and Mounjaro (tirzepatide), has transformed how obesity and type 2 diabetes are managed in the United States. While these medications a...
FDA Clears Microbot Medical’s LIBERTY® Endovascular Robotic System: A New Era in Vascular Intervention
September 2025 – Washington, D.C. — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Microbot Medical’s LIBERTY® Endovascular Robotic System, making it the first fully disposable, remotely operated robotic system authorized...
FDA Flags Hamilton Medical Ventilators and Breathing Circuits Over Serious Safety Risks
Class I recall and correction highlight vulnerabilities in anesthesia and respiratory care equipment The U.S. Food and Drug Administration (FDA) has issued multiple Class I safety actions against products manufactured by Hamilton Medical, a leading s...
FDA Recalls Ambu SPUR II Manual Resuscitators Over Blocked Manometer Port Defect
Critical backup ventilation devices face Class I recall due to risk of inaccurate airway pressure monitoring The U.S. Food and Drug Administration (FDA) has issued a Class I recall, its most serious designation, for specific batches of Ambu SPUR II m...
B. Braun Recalls IV Fluids Due to Particulate Contamination: Hospitals Urged to Audit Inventories
August 21, 2025 Bethlehem, PA — B. Braun Medical has initiated a nationwide recall of two intravenous fluid products after identifying the presence of particulate matter in certain lots, according to a company statement and confirmation by the U.S. F...
URGENT DEVICE RECALL: Boston Scientific's Carotid WALLSTENT Monorail Under Class I FDA Recall
August 22, 2025 Washington, D.C. — The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—for Boston Scientific’s Carotid WALLSTENT Monorail Endoprosthesis due to a manufacturing defect that may pose significant...
FDA Grants Historic Approval of Precigen’s Papzimeos: First-Ever Therapy for Rare Respiratory Disease
On August 15, 2025, the U.S. Food and Drug Administration (FDA) approved Papzimeos (zopapogene imadenovec-drba), the first therapy ever approved for recurrent respiratory papillomatosis (RRP)—a rare, debilitating, and sometimes life-threatening respi...
FDA Issues Safety Alert on Boston Scientific’s Watchman Access Systems — Procedural Risks Under Review
On August 5, 2025, the U.S. Food and Drug Administration (FDA) released an early safety alert for Boston Scientific’s Watchman Access Systems, which are used in implanting the Watchman left atrial appendage occlusion (LAAO) device. The alert follows ...
FDA Confirms U.S. IV Saline Shortage Resolved — A Critical Recovery for Surgical Operations
On August 8, 2025, the U.S. Food and Drug Administration (FDA) officially declared the national shortage of intravenous (IV) saline solutions resolved. This supply disruption, which began in late 2024, had forced hospitals and ambulatory surgery cent...
New Brain Implant Brings Hope for Stroke Survivors: First U.S. Patient Treated at UW Medicine
New Brain Implant Brings Hope for Stroke Survivors: First U.S. Patient Treated at UW Medicine In a landmark step for stroke recovery and brain-computer interface technology, UW Medicine in Seattle has become the first U.S. institution to surgically i...
FDA Approves First Device to Treat Rheumatoid Arthritis Without Medication: A Paradigm Shift
In an unprecedented milestone for autoimmune disease management, the U.S. Food and Drug Administration (FDA) has officially approved the SetPoint System, a first-in-class neuroimmune modulation implant designed to treat moderately to severely active ...
FDA Issues Class I Recall of Ethicon Stapler Reloads; CMS Proposes Payment Rule Changes as ASC Market Expands
On July 25, 2025, the FDA issued a Class I recall for nearly 700,000 Endopath Echelon vascular stapler reloads due to inadvertent lock out during surgery—capable of causing bleeding, procedural delays, and death. Simultaneously, key regulatory and ec...
Biodegradable Balloon Spacer Surgery on 72-Year Old Marks Milestone for Minimally Invasive Orthopedics
In July 2025, orthopedic surgeons in India performed a rare and innovative shoulder surgery that is quickly gaining global attention. At King George’s Medical University (KGMU) in Lucknow, a 72-year-old woman became the first patient in Uttar Pradesh...
Robotic Revolution in Cardiac Care
In a landmark moment for U.S. medicine, Baylor St. Luke’s Medical Center in Houston has successfully performed the nation’s first fully robotic heart transplant, marking a transformative step in the evolution of cardiothoracic surgery. The operation,...
SRT H: Johns Hopkins’ AI-Driven Robot
In a significant advance for robotic surgery, researchers at Johns Hopkins University have introduced the SRT H (Surgical Robot Transformer–Hierarchy) system, which successfully performed eight full laparoscopic gallbladder removals on pig organs in ...
Medtronic’s Hugo Surgical Robot Achieves Breakthrough
In a major milestone for surgical robotics, Medtronic has announced that its Hugo™ Robotic-Assisted Surgery (RAS) system has successfully met all primary endpoints in a large-scale U.S. clinical trial for urologic procedures, paving the way for an an...
Catheter innovation reshaping US surgical landscape
In a week marked by breakthroughs across neuroscience, oncology, and vascular intervention, U.S. clinicians and procurement leaders face a new frontier in hybrid surgical care. Three distinct innovations ranging from neuron transplantation to immuno-...
FDA Finalizes 506J Notification
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released its final guidance titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” This landmark regulation...
Laparoscopic Device Market in 2025
The U.S. laparoscopic devices market is undergoing significant transformation in 2025, spurred by the increasing shift toward minimally invasive surgical procedures. As hospitals and ambulatory surgical centers (ASCs) continue to prioritize patient o...
FDA Warns Hemodialysis Bloodline
The U.S. Food and Drug Administration (FDA) has issued a public warning that critical shortages of hemodialysis bloodlines are expected to continue through at least early fall 2025. Hemodialysis bloodlines, which are integral components of dialysis s...
Surgical Supply Chain Management
In the realm of healthcare, surgical supply chain management is a critical aspect that directly impacts both the efficiency of medical procedures and the overall cost-effectiveness of healthcare institutions. This article delves into various strategi...
The Impact of AI on Surgical Procedures
The advent of Artificial Intelligence (AI) in surgery has catalyzed a paradigm shift in medical practice, heralding an era of precision medicine. AI's potential to transform surgical procedures is immense, offering unprecedented levels of accuracy, e...
Orthopedic Implants
In the realm of medical science, orthopedic implants stand as a testament to the astonishing leaps of innovation. These crucial medical devices have not only enhanced the quality of life for millions but have also paved the way for increased mobility...
Electrosurgical Devices
The integration of electricity with surgical procedures might seem like something out of science fiction. However, in today's modern medical landscape, electrosurgical devices are not just a reality but a vital tool that is reshaping the realm of sur...
Laparoscopic Devices
In the ever-evolving world of medical technology, laparoscopic devices have marked a significant turning point in surgical procedures. These devices, which have been continuously refined and improved upon over the years, are making it possible for su...
Robotic Surgery
As medical technology makes leaps and bounds into the future, robotic surgery emerges as one of the most significant breakthroughs, promising a revolution in the field of surgery. These cutting-edge robotic systems are enhancing the capabilities of s...