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June 15, 2022

FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff

Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.

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May 31, 2022

FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff

As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.

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Coronavirus
January 28, 2022
Coronavirus

Rutgers New Jersey Medical School Develops Rapid Test for COVID-19 Variants

By MedTech Intelligence Staff

The test detects all known variants of SARS-CoV-2, including alpha, beta, gamma and omicron.

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April 3, 2026

Merit Medical Acquires View Point Medical, Inc., expanding the Merit Therapeutic Oncology Portfolio

By MedTech Intelligence Staff
merit medical

The acquisition expands Merit’s portfolio of therapeutic oncology products dedicated to the accurate diagnosis and localization of breast and soft tissue tumors.

April 1, 2026

How Rural Health Systems Are Advancing Cardiac Imaging

By Dr. Joseph Cardenas, Dr. Khidir Osman MD, FACC

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.

March 6, 2026

Philips unveils Rembra CT for acute and high-demand imaging environments

By MedTech Intelligence Staff
Philips

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.

March 5, 2026

RadNet Acquires Gleamer to Support Position as a Radiology Clinical AI Solutions Leader

RadNet leadership says the acquisition of Biocare enhances Agilent’s pathology portfolio and reflects our strategy to drive long-term growth through customer-centric innovation and disciplined capital allocation.

March 5, 2026

Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology

Cloud-based SaMD (Software as a Medical Device) designed to assist healthcare providers in predicting delivery date using ultrasound imaging

August 21, 2025

Labcorp Launches First FDA-Cleared Blood Test for Alzheimer’s Disease 

Lumipulse® pTau-217/Beta Amyloid 42 Ratio now available nationwide through Labcorp.

August 13, 2025

Gentuity LLC and GE HealthCare to Collaborate on Advanced Intravascular Imaging Platform

The two companies announced co-marketing initiatives and technical integration among their advanced intravascular imaging technologies.

July 9, 2025

FDA 510(k) Clearance for Mendaera Handheld Robotic System

Focalist device

Pioneering a new category of robotics in healthcare, Mendaera’s Focalist™ System, cleared for precise instrument placement during ultrasound-guided procedures for one of medicine’s most common and critical techniques.

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