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.
Biotronik has received U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead, growing access to a solution for Left Bundle Branch Area Pacing (LBBAP).
The post FDA Approval for BIOTRONIK Solia CSP S Pacing Lead For LBBAP appeared first on MedTech Intelligence.
New patient-specific solution expands Catalyst’s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy .
The post Catalyst OrthoScience gets FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty appeared first on MedTech Intelligence.
Trauma and Extremities partnership aligns disciplined approach to portfolio optimization and focuses on delivering long-term value for surgeons and patients
The post Smith+Nephew signs distribution agreement with SI-BONE appeared first on MedTech Intelligence.
Quantum Surgical and NeuWave Medical, Inc. – both of which share an extensive focus on innovation to improve cancer patients’ outcomes – will operate as subsidiaries of Precision IO Group Inc., the newly created parent company led by medtech veteran Kurt Azarbarzin, who was recently appointed CEO.
The post Quantum Surgical Acquires NeuWave Medical, Inc. appeared first on MedTech Intelligence.
Synchfix EVT features an all-in-one system that integrates suture tensioning handles within the implant instrumentation, along with a handle design for one-handed surgical implant deployment.
The post Stryker launches Synchfix™ EVT, expanding options for flexible syndesmotic fixation appeared first on MedTech Intelligence.
Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.
The post Decision Criteria for Technology Commercialization of Medical Devices in 2026 appeared first on MedTech Intelligence.
While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient care.
The post Continuous Cardiac Monitoring: Redefining the “End” of a Clinical Study? appeared first on MedTech Intelligence.
Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.
The post Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care appeared first on MedTech Intelligence.
Innovation, implementation & utilization of medical technology
