FDA clearance of the BCL System will give surgeons access to precise information about each breast tumor that has never before been available to them, according to the company.
The post Breast Cancer Locator System Submitted for De Novo 510(k) by Cairn Surgical appeared first on MedTech Intelligence.
Several surgeons debuted spine devices and other techniques during the first quarter from cervical discs to personalized implants.
The post 17 spine surgery firsts in Q1 appeared first on MedTech Intelligence.
Mindray says its entry into the ventilator market marks a significant step in expanding advanced respiratory care options for clinicians and patients, reinforcing the medical device leader’s commitment to driving innovation in healthcare.
The post Mindray North America Enters Ventilator Market appeared first on MedTech Intelligence.
Hypoglossal nerve stimulation therapy approved in the U.S. without complete concentric collapse contraindication or warning language. The next-generation, MRI-compatible device is expected to launch in the first half of 2027, pending FDA supplement review.
The post LivaNova Receives FDA Premarket Approval for to treat Moderate to Severe Obstructive Sleep Apnea appeared first on MedTech Intelligence.
Perfuze states the Millipede88 is the first 088 aspiration catheter with patented corrugated technology cleared for standalone direct aspiration — no large-bore intermediary required — backed by independently adjudicated MARRS study data showing a 77% first-pass effect1 in M1 occlusions and 96% delivery success.
The post Perfuze Receives FDA 510(k) Clearance for Millipede88 Aspiration Catheter appeared first on MedTech Intelligence.
The medical device industry and EPA have been in ongoing debate over balancing the need for sterile medical equipment with concerns about pollution near sterilization plants.
The post EPA proposes new rule on Ethylene Oxide Emissions: Could Loosen Limits on Medical Device Sterilization appeared first on MedTech Intelligence.
The Urocross Expander System is designed to remodel the obstructing prostatic lobes during the six-month indwell time and is intentionally retrieved, leaving no permanent foreign material behind.
The post Prodeon Medical FDA 510(k) approved for the Urocross Expander System, a Non-Permanent Retrievable Implant for Treating Benign Prostatic Hyperplasia appeared first on MedTech Intelligence.
With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating clinical study sites.
The post JenaValve Gets FDA Nod for Trilogy Transcatheter Heart Valve (THV) to Treat Aortic Regurgitation (ssAR) appeared first on MedTech Intelligence.
To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.
The post Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First? appeared first on MedTech Intelligence.
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850).
The post FDA Town Hall: FDA’s Quality Management System Regulation (QMSR) – Medical Device Risk-Based Inspections appeared first on MedTech Intelligence.
The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
The post FDA Launches New Adverse Event Look-Up Tool appeared first on MedTech Intelligence.
FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.
The post FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss appeared first on MedTech Intelligence.
A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration's (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.
The post The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices appeared first on MedTech Intelligence.
Iran-linked hackers claim cyberattack launched against U.S. medtech company Stryker.
The post Stryker Cyber Attack Being Reported as Iranian War Retaliation appeared first on MedTech Intelligence.
CE Marked and 510(k) pending, Philips says Rembra’s advanced image reconstruction technology delivers up to 106 images per second and a high throughput of up to 270 patients per day [2] to support faster diagnosis by making scans available in near-real time.
The post Philips unveils Rembra CT for acute and high-demand imaging environments appeared first on MedTech Intelligence.
According to a company press release, RadNet, Inc. has acquired Gleamer SAS, a leading radiology AI company based in Paris, France. The acquisition will be integrated into DeepHealth, RadNet’s wholly owned subsidiary and further expands DeepHealth’s AI-powered health informatics solutions and services. With more than 130 professionals, Gleamer is a fast growing, cloud-first, radiology AI…
The post RadNet Acquires Gleamer to Support Position as a Radiology Clinical AI Solutions Leader appeared first on MedTech Intelligence.
Cloud-based SaMD (Software as a Medical Device) designed to assist healthcare providers in predicting delivery date using ultrasound imaging
The post Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology appeared first on MedTech Intelligence.
Abbott’s CardioMEMS™ HERO is a compact remote reader that is 60% lighter compared to its previous generation device for heart failure patients with Abbott’s CardioMEMS pulmonary artery pressure sensor.
The post Abbott CardioMEMS™ remote heart failure monitoring reader receives FDA approval appeared first on MedTech Intelligence.
The Revello™ Vascular Covered Stent is designed to combine the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries. Iliac artery disease is a key component in lower‑extremity peripheral artery disease (PAD), and according to a company Press Release, Revello™ can help reduce a substantial disability burden across the EU's aging population.
The post BD Gets CE Mark for Revello Vascular Covered Stent appeared first on MedTech Intelligence.
What is driving the need for increased transparency across the MedTech organization relative to product innovation, development and commercialization?
The post Why Digital Tool are Needed to Cope with Increasing Pressures in MedTech Innovation appeared first on MedTech Intelligence.
Innovation, implementation & utilization of medical technology
