Device Sectors / Diagnostics | Medical Product Outsourcing

Diagnostics

Capitainer Releases to Market its Fully Automated Sample Handler

First unit is delivered to a life sciences/medicine research center in Sweden.

Michael Barbella, Managing Editor 05.31.23

Diagnostics

GE HealthCare's Precision DL Deep Learning Image Processing Software Earns FDA Nod

Precision DL offers image quality benefits usually associated with hardware-based time-of-flight reconstruction.

Sam Brusco, Associate Editor 05.30.23

Diagnostics

NovaScan, PHC Corporation Working on Skin Cancer Detection Device

The product would provide comprehensive real-time margin detection for non-melanoma skin cancers.

Michael Barbella, Managing Editor 05.26.23

Diagnostics

FDA OKs Thermo Fisher's Breakthrough Preeclampsia Immunoassays

The first, only immunoassays to gain breakthrough designation and clearance for risk assessment and clinical management of preeclampsia.

Sam Brusco, Associate Editor 05.19.23

Diagnostics

Hologic's Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Gains FDA Nod

The assay is a molecular test that spots and differentiates four of the most common respiratory viruses.

Sam Brusco, Associate Editor 05.19.23

Diagnostics

Phenomix Sciences Debuts Test to Predict Obesity Phenotype

Saliva test will assist in provider recommendations with positive results pointing to diet, GLP-1 medication, and/or intragastric balloons.

Michael Barbella, Managing Editor 05.19.23

Cardiovascular | Diagnostics | Patient Monitoring

Abbott's Assert-IQ ICM Earns FDA Nod

The insertable cardiac monitor (ICM) offers up to six years of battery life.

Sam Brusco, Associate Editor 05.18.23

Diagnostics

Owlstone Medical Wins DoD Contract to Develop Handheld Breath Biopsy Device

Initial award recognizes potential of proprietary Owlstone Medical technology for non-invasive viral and bacterial respiratory infectious disease detection.

Charles Sternberg, Associate Editor 05.18.23

Diagnostics

Philips Rolls Out AI-Powered CT System

Accelerates routine radiology and high-volume screening programs.

Charles Sternberg, Associate Editor 05.17.23

Diagnostics

Hologic Partners with Kelee Ringo & Family to Highlight the Importance of Mammograms

In a series of interviews, appearances & more, Ringo and his mother will encourage women not to delay annual screenings.

Charles Sternberg, Associate Editor 05.16.23

Diagnostics

BD Receives FDA 510(k) Clearance for BD Kiestra MRSA Imaging Application

Uses artificial intelligence (AI) to interpret bacterial growth and release negative specimens with minimal human interaction.

Charles Sternberg, Associate Editor 05.16.23

Diagnostics

GE HealthCare Presents New Innovations at ESTRO 2023 Congress

Showcases Intelligent Radiation Therapy, Auto Segmentation and an updated Magnetic Resonance Radiation Therapy Suite.

Charles Sternberg, Associate Editor 05.16.23

Diagnostics

Philips to Pay Over $62M to Resolve FCPA Charges

Philips was alleged to violate the FCPA with respect to conduct related to medical diagnostic equipment sales in China.

Sam Brusco, Associate Editor 05.15.23

Diagnostics

Carestream Health Launches DRX-Rise Mobile X-Ray System

Gives customers an affordable path to digital imaging.

Charles Sternberg, Associate Editor 05.12.23

Diagnostics

bioMérieux Invests in Proxim Diagnostics

Proxim’s handheld device expected to increase global access to high-quality, low-cost diagnostics.

Michael Barbella, Managing Editor 05.11.23

Diagnostics | Surgical

TransMed7 Marks First Clinical Use of VacuPac

The attachment is used for all the company's vacuum-assisted, single insertion - multiple collection breast biopsy platforms.

Michael Barbella, Managing Editor 05.11.23

Diagnostics | Digital Health

PreciPoint's iO:M8 Microscope Receives CE-IVD Certification

The microscope is designed to help advance digitization in healthcare.

Michael Barbella, Managing Editor 05.10.23

Diagnostics

IVD Manufacturers Are Being Put to the Test

The COVID-19 pandemic has accelerated the trend toward home diagnostics and raised the bar for faster, more detailed test results.

Michael Barbella, Managing Editor 05.09.23

Chronic Disease | Diagnostics

Nucleix Earns FDA Nod for Non-Muscle Invasive Bladder Cancer Monitoring

Bladder EpiCheck it a sensitive, specific test to analyze subtle, disease-specific changes across 15 methylation markers associated with bladder cancer.

Sam Brusco, Associate Editor 05.05.23

Diagnostics