Medical Product Outsourcing

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

Chronic Disease

NeoDynamics’ NEONAVIA Biopsy System Becomes Available in The U.S.

The system will be debuted at two upcoming Conferences for Breast Surgeons and Breast Imaging Professionals.

Charles Sternberg, Associate Editor 04.27.23

Surgical

TransMed7's Concorde Soft Tissue Biopsy Devices Used in First Clinical Cases

Product is based on the company's patented Zero5 work element composed of a fused, single element constructed from three hypotubes.

Michael Barbella, Managing Editor 03.31.23

Steady Growth Forecast for Global Biopsy Guns Market

Increasing awareness of men’s health will likely fuel the sector's expansion.

Michael Barbella, Managing Editor 02.10.23

Diagnostics

Owlstone Medical Introduces Breath Biopsy VOC Atlas

Provides insight and scientific context into VOC molecules, supporting biomarker discovery through incorporation into Owlstone’s Breath Biopsy OMNI platform.

Charles Sternberg, Associate Editor 12.12.22

Diagnostics

FDA Approves NeoDynamics' NeoNavia Pulse Biopsy System

Uses patented pulse technology for controlled, accurate needle insertion.

Sam Brusco 09.08.22

Diagnostics

FDA Clears Serpex's Compass Steerable Needle for Lung Biopsy

Second 510(k) clearance of Its steerable endobronchial instrument platform.

Sam Brusco, Associate Editor 09.08.22

Surgical

TransMed7 Achieves First-in-Human for Heron Soft Tissue Biopsy Devices

First-in-human clinical case for the commercial production version of a Heron XPS device.

Sam Brusco, Associate Editor 08.16.22

FDA Grants Breakthrough Designation to Endoscopic Biopsy Device

Limaca Medical's Precision-GI device obtains tumor tissue within or adjacent to the gastrointestinal tract.

Michael Barbella, Managing Editor 06.10.22

Surgical

Biobot Surgical's Robotic Prostate Biopsy/Ablation Needle Guidance Earns FDA Nod

iSR'obot Mona Lisa 2.0 positions prostate biopsy or treatment needles transperineally

Sam Brusco, Associate Editor 03.07.22

Surgical

Intuitive Releases Ion Endoluminal System Lung Biopsy Post-Market Data

Ion system for pulmonary nodule biopsy resulted in an 83 percent diagnostic yield.

GlobeNewswire 10.18.21

Saliva Liquid Biopsy

Early Cancer Detection, Monitoring Treatment Response, Analysis of Resistance, Detection of Recurrence

IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

Product has three programmable firing modes for tissue sampling.

Michael Barbella, Managing Editor 04.19.21

Diagnostics

Owlstone Medical Introduces Breath Biopsy Panel for Respiratory Diseases

Supports research to distinguish between different types of chronic inflammatory airway diseases.

Owlstone Medical 01.19.21

First Clinical Use of TransMed7's Soft Tissue Breast Biopsy Devices

The products can leverage VacuPac, which avoids the need for external tubes and power cords, and VacuTower, portable, external vacuum devices.

Business Wire 10.30.20

Diagnostics

GE Healthcare Introduces Serena Bright Contrast-Enhanced Guided Biopsy

Will help empower clinicians and patients in their fight against breast cancer.

Business Wire 10.21.20

Chronic Disease | Diagnostics

Hologic Updates Brevera Breast Biopsy Platform

Now features new functionality, simplified storage, and improved waste management.

Hologic Inc. 09.02.20

Diagnostics

FDA OKs TransMed7's Ultrasound and Stereotactic Soft Tissue Biopsy Devices

Combines advantages of forward and side coring capabilities into a single needle platform.

Business Wire 09.01.20

Diagnostics

FDA Approves First Liquid Biopsy NGS Companion Dx Test

Guardant360 CDx identifies specific EGFR gene mutations in a deadly form of metastatic non-small cell lung cancer.

PR Newswire 08.10.20

Diagnostics

FDA OKs GE Healthcare's Contrast-Enhanced Mammography Solution for Biopsy

Benefits include shortened procedure time, improved patient comfort, and reduced cost.

GE Healthcare 06.10.20

Diagnostics

Blood Test May Help Doctors Catch Pancreatic Cancer Early

Penn study shows liquid biopsy may be viable option for both diagnosis and disease staging.

Penn Medicine 04.16.20

Surgical

FDA Clears CrossBay Medical's CrossGlide Endometrial Tissue Sampler

Endometrial biopsy procedures can be done gently, effortlessly, and without a tenaculum.

Business Wire 04.02.20

Neil Tween Joins Owlstone Medical

Neil Tween appointed as Chief Financial Officer.

Owlstone Medical 03.30.20

Chronic Disease | Diagnostics

Crumpled Graphene Makes Ultra-Sensitive Cancer DNA Detector

Crumpling graphene makes it more than ten thousand times more sensitive to DNA.

University of Illinois at Urbana-Champaign, News Bureau 03.24.20

Diagnostics

Co-Diagnostics Closes $5 Million in Registered Direct Offering

Company plans to use the funding to commercialize and expand its infectious disease testing, agrigenomics, and vector control verticals.

Business Wire 03.09.20

Diagnostics

Progress in Noninvasive Urine Test for Prostate Cancer

Liquid biopsy test will detect prostate cancer from RNA and other metabolic chemicals in the urine.

John Hopkins Medicine 03.02.20

Freudenberg Medical Showcasing Products and Processing Technologies at MD&M West

Multi-lumen silicone tubing, tri-layer tubing, and a conductive silicone compound are among the innovations on display this week.

Freudenberg Medical 02.12.20

Cambus Medical Introduces Custom and Specialty Needles

Velona needles are designed for fine needle aspiration, fine needle biopsy, minimally invasive delivery systems, and structural heart applications.

Cambus Medical 02.03.20

Diagnostics

Biopsy Devices Revolutionizing Breast Cancer Diagnosis

Biopsies are becoming less invasive and more accurate.

Online Exclusives Hrishikesh Kadam, Research Content Developer, Global Market Insights Inc. 01.30.20

Diagnostics

Qlarity Imaging Adds Breast MRI Biopsy Guidance to QuantX

A new 510(k) clearance expands the capacity of the first FDA-cleared computer-aided breast cancer diagnostic system.

Business Wire 01.09.20

Diagnostics

FDA Approves Hologic's 3DQuorum Imaging Technology

The technology is available as part of the new Hologic Clarity HD Plus package for use with existing and future Hologic 3D mammography systems.

Business Wire 01.03.20

Diagnostics

Owlstone Medical, Thermo Fisher Partner to Advance Early Disease Detection

Thermo Fisher Scientific' Orbitrap GC-MS technology to be integrated into Breath Biopsy to identify novel biomarkers for early disease detection.

Owlstone Medical 12.18.19

Neurological | Surgical

Medtronic Expands Surgical Synergy with FDA Clearance of the Stealth Autoguide System

Robotic trajectory guidance platform integrates multiple enabling technologies to support complex cranial procedures.

Globe Newswire 12.18.19

Diagnostics

RSNA News: Siemens Introduces AI-Based MRI Assistants

Expands diagnostic offerings to increase efficiency.

Siemens Healthineers 12.02.19

Diagnostics

Improved Biopsies with MRI-Compatible Ultrasound System

Minimally invasive diagnostics with multimodal imaging.

Fraunhofer-Gesellschaft 11.18.19

Packaging & Sterilization

Georgia Bio Responds to Potential BD EtO Sterilization Plant Shutdown

The association is concerned the closure may lead to a medical device shortage and impact patients.

Business Wire 10.28.19

Diagnostics

GE Healthcare & Premier Inc. to Develop Model for One-Stop Breast Cancer Diagnostic Center

Women can wait weeks for a follow-up exam to evaluate the results of a suspicious mammogram.

GE Reports 10.17.19

Diagnostics

Cleveland Diagnostics' Prostate Cancer Test Gains Breakthrough Status

IsoPSA assay shown to have significant superior diagnostic accuracy when compared to traditional prostate-specific antigen (PSA) tests.

Business Wire 10.16.19

Surgical

CE Mark Granted to Crossbay Medical for its Endometrial Tissue Sampler

ETS is the third product using CrossGlide technology.

PR Newswire 10.08.19

Healthcare Veteran Joins MRI Interventions' Board of Directors

New member currently is president of Affinity Capital Management.

Globe Newswire 09.30.19

FUJIFILM Releases Tomosynthesis Biopsy Option for ASPIRE Cristalle Mammography System

The product combines Hexagonal Close Pattern (HCP) capture technology and intelligent image processing.

FUJIFILM Medical Systems USA Inc. 09.16.19

Diagnostics

Novel Device Could Provide Early Oral Cancer Detection

Researcher is developing fluorescence imaging endoscopes and combining them with artificial intelligence technologies.

University of Oklahoma 09.12.19

Diagnostics

Owlstone Makes Advancements in Breath Biopsy Platform

Launches next gen breath sampler and portable air supply.

Owlstone Medical 09.06.19

Diagnostics

LAM's Liquid Biopsy Liver Cancer Detection Test Wins Breakthrough Status

Blood-based liquid biopsy test analyzes DNA methylation pattern of cell-free DNA (cfDNA), indicating presence of hepatocellular carcinoma as early as Stage I.

PR Newswire 09.03.19

Surgical