Biopsy Devices Pipeline Insights

DelveInsight’s “Biopsy Devices – Pipeline Insight and Competitive Landscape, 2023,” report provides comprehensive insights about 20+ companies and 23+ pipeline devices in biopsy devices pipeline landscape. Significant increase in incidence of cancer, such as breast, prostate, and lung, and rapid technological advancements such as 3D optical biopsies, MRI-targeted biopsies, and Ultrasound–guided biopsies fuel the adoption of biopsy devices.


Moreover, rise in awareness on diagnosis of chronic diseases fosters the demand for integrated biopsy technologies such as stereo-tactic-guided biopsy.


This reports provides a detailed study of the emerging biopsy devices along with competitive landscape to help better understand the market.  

Geography Covered

  • Global coverage

Biopsy Devices Overview

Biopsy Devices: Understanding

Biopsy devices are instruments that aid in the removal of tissue samples from the body. These samples are collected in order to examine it more closely.

When a Biopsy is needed?

  • A mammogram shows a lump or mass, indicating the possibility of breast cancer
  • A mole on the skin has changed shape recently and melanoma is possible
  • A person has chronic hepatitis and it's important to know if cirrhosis is present

Biopsy Devices Competitive Assessment

This segment of the biopsy devices pipeline report encloses its detailed analysis of various pipeline devices which include product description, licensing and collaboration details and other developmental activities including the latest news and press releases. The report also provides list of major players involved in the pipeline product development.


  • Product Type

Biopsy devices pipeline report is segmented based on product type such as core biopsy devices, aspiration biopsy needles and vacuum assisted biopsy devices.


  • Product Technique

Based on the technology biopsy devices are of various types:

  •  Ultrasound-guided Biopsy
  •  Stereotactic-guided Biopsy
  •  MRI-guided Biopsy

The biopsy device pipeline assessment covers the entire types of these techniques.


  • Product Application

The biopsy devices are used in breast biopsy, lung biopsy, colorectal biopsy and prostate biopsy. 


  • Major Players in Biopsy Devices

There are approx. 20+ key companies which are developing the products for biopsy devices.


  • 3D Biopsy Device: 3DBiopsy, Inc.

3DBiopsy is developing a new variable biopsy device, capable of taking a prostate specimen up to 2 to 5 cm in length, along with a biopsy needle that retrieves over 90% of the tissue sampled. The current biopsy devices take short (average 12 mm) fragmented specimens which miss cancers in 30% and mischaracterize the tumor aggressiveness in up to 50%. Patients undergoing MRI targeted fusion biopsy also require additional sampling due to the inadequacy of the shorter specimens. The Company’s device will sample both peripheral and anterior zones and is capable of completely encompassing regions of interest when MRI fusion is performed.


  • The OsteoAccess System: ActuatedMedical

Actuated Medical developed the OsteoAccess System to assist clinicians in bone marrow biopsy and aspiration procedures. The System uses controlled, micron-scale needle vibration to reduce the penetration force enabling easier cortical bone access.

Further product details are provided in the report……..

Biopsy Devices: Competitive Benchmarking

This segment of the reports provides analysis of the pipeline report to give a clear understanding of the comparative analysis.

The analysis is based on

  • Brand Positioning of Leading companies
  • Application
  • Industry Collaborations

Biopsy Devices: Commercialization Activity

This segment of the report provides a detailed list of any commercial activity in the field of biopsy devices ranging from collaboration, mergers and acquisition, recent breakthrough among others.

Development Activities

  • In February 2019, University of Cambridge and Cambridge University Hospitals (CUH) researcher and urologist developed the CamProbe as a prototype to take safer prostate biopsies. The device is in the clinical stage.
  • In June, 2019 the first of its kind “virtual biopsy” devices has been created by Rutgers University scientist. It uses sound vibrations and pulses of near-infrared light that can quickly determine a skin lesion's depth and potential malignancy without using a scalpel.

Further commercial activities are provided in the report……..

Biopsy Devices: Reimbursement 

  • US

Since January 2003, Medicare covers percutaneous image-guided breast biopsy using stereotactic or ultrasound imaging for a radiographic abnormality that is nonpalpable and is graded as a BIRADS III, IV, or V. Palpable Breast Lesions Effective January 1, 2003, Medicare covers percutaneous image guided breast biopsy using stereotactic or ultrasound imaging for palpable lesions that are difficult to biopsy using palpation alone.

Further information is provided in the report……..

Report Highlights

  • Extensive coverage of the biopsy devices under development
  • The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
  • The report reviews the major players involved in the development of biopsy devices and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment / industry
  • The report consists of in depth analysis of pipeline products based on various parameters

Biopsy Devices Report Insights

  • Biopsy Devices - Pipeline Analysis
  • Biopsy Devices - Unmet Need
  • Biopsy Devices - Market Dynamics
  • Biopsy Devices - Future Perspectives and Conclusion
  • Biopsy Devices - Analyst Views

Key Questions

  • What are significant companies in this segment, their information, analysis, and insights to improve R&D strategies?
  • How to identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage?
  • What are important and diverse types of biopsy devices under development?
  • What are market-entry and market expansion strategies in biopsy devices?
  • What are some of the mergers and acquisitions and to identify major players with the most promising pipeline?
  • What is in-depth analysis of the product’s current stage of development, territory and estimated launch date?


1. Key Insights

2. Biopsy Devices: Snapshot

3. Biopsy Devices

3.1. Product Overview

3.2. Regulatory Approvals based on Class

3.3. Indications

3.4. Mechanism

4. Biopsy Devices: Competitive Assessment

4.1. Assessment by Product Type

4.1.1. Core biopsy devices

4.1.2. Aspiration biopsy needles

4.1.3. Vacuum assisted biopsy devices

4.2. Assessment by Technique

4.2.1. Ultrasound-guided Biopsy

4.2.2. Stereotactic-guided Biopsy

4.2.3. MRI-guided Biopsy

4.3. Assessment by Application

4.3.1. Breast biopsy

4.3.2. Lung biopsy

4.3.3. Colorectal biopsy

4.3.4. Prostate biopsy

4.4. Assessment by Company

4.4.1. 3D Biopsy, Inc 3D Biopsy Device: 3DBiopsy, Inc. Product Information Research and Development Patent Details Regulatory Milestone

4.4.2. ActuatedMedical The OsteoAccess System: ActuatedMedical Product Information Research and Development Patent Details Regulatory Milestone

*More Companies and products would be added in the final report

5. Biopsy Devices: Competitive Benchmarking : By Company

5.1. Brand Positioning of Leading companies

5.2. Analysis based on Application

5.3. Analysis based on Industry Collaborations

6. Biopsy Devices – Commercialization Activity

6.1. Collaboration

6.2. Licensing

6.3. Merger and Acquisition

6.4. Recent Breakthrough

6.5. Literature Studies

6.6. KOL Views

7. Biopsy Devices: Regulatory

7.1. US

7.2. Europe

7.3. Japan

8. Biopsy Devices: Reimbursement

8.1. Case Study - US

8.2. Case Study - Europe

Case Study -Japan

9. Biopsy Devices: Market Dynamics

9.1. Unmet Needs

9.2. Market Drivers

9.3. Market Barriers

10. DelveInsight’s Analytical Perspective

10.1. PEST Analysis

10.2. Future Growth Perspectives

11. Conclusion

12. Appendix 

12.1. Research Methodology

12.1.1. Coverage

12.1.2. Secondary Research

13. Bibliography

14. DelveInsight Capabilities

15. Disclaimer

16. About DelveInsight


List of Tables

Table 1 Total Pipeline Products

Table 2 Pipeline Products by Type

Table 3 Pipeline Products by Technique

Table 4 Pipeline Products by Application

Table 5 List of Companies

Table 6 3DBiopsy, Inc. Pipeline Products & Ongoing Clinical Trials Overview

Table 7 3D Biopsy Device – Product Status

Table 8 3D Biopsy Device – Product Description

Table 9 ActuatedMedical Pipeline Products & Ongoing Clinical Trials Overview

Table 10 The OsteoAccess System – Product Status

Table 11 The OsteoAccess System – Product Description

List of Figures

Figure 1 List of Pipeline Products

Figure 2 Ongoing Clinical Trial Pipeline Products by Type

Figure 3 Ongoing Clinical Trial Pipeline Products by Technique

Figure 4 Ongoing Clinical Trial Pipeline Products by Application

• 3DBiopsy Inc

• Actuated Medical Inc

• Arch Medical Devices Ltd

• Boston Scientific Corp

• C. R. Bard Inc

• CleveX, Inc.

• Control Medical Technology LLC

• Crux Medical Innovations

• Data Driven Diagnostic Sciences Inc

• Dune Medical Devices Ltd

• Endoscopic Assist Devices LLC

• LX Medical Corp

• MI4 Spine, LLC

• MRI Interventions Inc

• Promaxo Inc

• Quality ElectroDynamics LLC

• Vascular BioSciences

• Verisante Technology Inc

• VitruMed Inc.

• Zamar Care

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