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Vascular Sciences

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2105 Twain Avenue
Carlsbad, CA 92008
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Diagnostics

Regulating IVDs and LDTs—Mike on Medtech

Mike Drues and Sean Fenske discuss proposed regulations around in vitro diagnostics and lab-developed tests.
Sean Fenske, Editor-in-Chief 08.10.21
Packaging & Sterilization

Facility Falsified Sterilization Data—Mike on Medtech

Mike Drues and Sean Fenske discuss troubling concerns over a sterilization provider in Italy.
Sean Fenske, Editor-in-Chief 07.27.21
Top 483s of 2020—Mike on Medtech

Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.
Sean Fenske, Editor-in-Chief 06.08.21
Reprocessing of Single-Use Devices—Mike on Medtech

Mike Drues and Sean Fenske discuss the European Commission’s guidelines for reprocessing single-use devices and the concerns with them.
Sean Fenske, Editor-in-Chief 04.27.21
BDP Reimbursement Delay—Mike on Medtech

Mike Drues and Sean Fenske discuss the causes for the delay in rolling out the four-year reimbursement policy for breakthrough devices.
Sean Fenske, Editor-in-Chief 03.30.21
Update on FDA's STeP Designation—Mike on Medtech

Mike Drues and Sean Fenske discuss the final guidance for the FDA’s STeP designation and who should use it.
Sean Fenske, Editor-in-Chief 02.26.21
Communicating with the FDA—Mike on Medtech

Mike Drues and Sean Fenske discuss methods of communicating with the agency and share best practices for doing so.
Sean Fenske, Editor-in-Chief 12.15.20
FDA Pre-Sub Best Practices—Mike on Medtech

Mike Drues and Sean Fenske discuss the most important factors to keep in mind when preparing to meet with the FDA during a pre-sub meeting.
Sean Fenske, Editor-in-Chief 04.24.20
COVID-19, Part 2—Mike on Medtech

Mike Drues and Sean Fenske discuss issues involved with misinformation around products to help treat COVID-19 and relaxed regulatory rules.
Sean Fenske, Editor-in-Chief 04.08.20
COVID-19, Part 1—Mike on Medtech

Mike Drues and Sean Fenske discuss Emergency Use Authorization and the potential problems with non-medical device manufacturers producing ventilators.
Sean Fenske, Editor-in-Chief 04.01.20
Packaging & Sterilization

EtO Sterilization Concerns—Mike on Medtech

Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.
Sean Fenske, Editor-in-Chief 03.30.20
Testing

Human Factors/Usability, Part 2—Mike on Medtech

Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.
Sean Fenske, Editor-in-Chief 02.03.20
Testing

Human Factors/Usability, Part 1—Mike on Medtech

Mike Drues and Sean Fenske discuss the importance of human factors within the regulatory landscape and how it came to matter to FDA.
Sean Fenske, Editor-in-Chief 02.03.20
Surgical

CMR Surgical Taps New CEO

Per Vegard Nerseth joins the company from ABB.
CMR Surgical 12.09.19
CSA Medical Receives European Approval for its RejuvenAir System

New technology treats COPD patients with chronic bronchitis.
PRNewswire 12.02.19
Diagnostics

Hologic Grows Its Portfolio of Breast Surgery and Pathology Solutions

Extends CE mark of LOCalizer and launches Unifi Workspace.
Hologic 11.26.19
R&D & Design

Pre-Filled Safety Syringes and the Self-Administration Trend

Providing patients with independence, while reducing risks.
George I’ons, Head of Product Strategy and Insights, Owen Mumford Pharmaceutical Services 11.21.19
Digital Health

DHIT and Tanjo Form a New Partnership

Drive the new HUG initiative in North Carolina.
DHIT 11.21.19
Beyond 510(k)/PMA: Safer Technologies Program—Mike on Medtech

Sean Fenske and Mike Drues discuss another new program from the FDA—the Safer Technologies Program (STeP)—and the details of it.
Sean Fenske, Editor-in-Chief 10.17.19
The NYT Editorial Board Statement—Mike on Medtech

Sean Fenske and Mike Drues discuss the recent comments made by the Board about the medical device industry and FDA.
Sean Fenske, Editor-in-Chief 06.17.19
510(k) Modernization—Mike on Medtech

Sean Fenske and Mike Drues discuss the potential changes coming to the 510(k) regulatory pathway and examine the issues around predicate devices.
Sean Fenske, Editor-in-Chief 01.25.19
Regulating the Practice of Medicine—Mike on Medtech

Sean Fenske and Mike Drues discuss the FDA's regulation of healthcare (or lack thereof) and if changes need to be made.
Sean Fenske, Editor-in-Chief 10.26.18
The Bleeding Edge, Part 3—Mike on Medtech

The conversation on The Bleeding Edge documentary concludes in this portion of the three-part podcast series.
Sean Fenske, Editor-in-Chief 09.26.18
Surgical

The Bleeding Edge, Part 2—Mike on Medtech

The discussion over the controversial Netflix documentary continues between Sean Fenske and Mike Drues in this episode.
Sean Fenske, Editor-in-Chief 09.07.18
Surgical

The Bleeding Edge, Part 1—Mike on Medtech

Sean Fenske and Mike Drues begin a multi-part series on the controversial Netflix documentary on the medtech industry.
Sean Fenske, Editor-in-Chief 09.05.18
Breakthrough Designation Program—Mike on Medtech

Sean Fenske and Mike Drues discuss the FDA's Breakthrough Designation Program and address common questions.
Sean Fenske, Editor-in-Chief 08.10.18
15 Tips for Getting New Products Through FDA—Mike on Medtech

Mike Drues provides insight to Sean Fenske on what he's learned about getting devices through the FDA over the last 15 years.
Sean Fenske, Editor-in-Chief 07.03.18
Digital Health | Electronics

Voice-Enabled Medtech—Mike on Medtech

Sean Fenske and Mike Drues discuss voice-enabled medtech and its potential in healthcare.
Sean Fenske, Editor-in-Chief 05.17.18
Changing Pathway to Market?—Mike on Medtech

Sean Fenske and Mike Drues discuss the changing MDR for CE mark and its impact on the “first to market” route companies take.
Sean Fenske, Editor-in-Chief 04.25.18
3D/Additive Manufacturing

3D Printing Healthcare at the Point of Care—Mike on Medtech

Sean Fenske and Mike Drues discuss the regulatory implications with 3D printing devices at a healthcare facility.
Sean Fenske, Editor 03.23.18
Quality vs. Regulatory—Mike on Medtech

Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.
Sean Fenske, Editor-in-Chief 03.02.18
The 'New' Alternative 510k—Mike on Medtech

Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.
Sean Fenske, Editor 01.29.18
Materials

Regulatory Approval Pathway for Biomaterials—Mike on Medtech

Mike Drues and Sean Fenske discuss the potential advantages of implementing an approval pathway for biomaterials.
Sean Fenske, Editor-in-Chief 01.02.18
R&D & Design | Testing

Pre-Sub with the FDA—Mike on Medtech

Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.
Sean Fenske, Editor-in-Chief 11.06.17
R&D & Design | Testing

Human Factors—Mike on Medtech

Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.
Sean Fenske, Editor-in-Chief 10.09.17
Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical

MDUFA IV and Its Impact on Medtech Innovation—Mike on Medtech

Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.
Sean Fenske, Editor-in-Chief 09.07.17
Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical

Off-Label Use—Mike on Medtech

Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.
Sean Fenske, Editor-in-Chief 08.25.17
Materials

Biomaterials, Biocompatibility, and Bioabsorbable—Mike on Medtech

Mike Drues speaks with Sean Fenske to discuss biomaterials, biofriendly, biocompatible, bioabsorbable, and more.
Sean Fenske, Editor-in-Chief 07.24.17
3D/Additive Manufacturing

3D Printing in Healthcare—Mike on Medtech

Mike Drues joins Sean Fenske to chat about the role of 3D printing in medtech and healthcare today and challenges that exist.
Sean Fenske, Editor-in-Chief 06.05.17
R&D & Design

Reimbursement for Engineers—Mike on Medtech

Sean Fenske and Mike Drues take a look at the relationship between medical device reimbursement and medtech product design and development.
Sean Fenske, Editor-in-Chief 05.05.17
Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical

Device Incident Reporting—Mike on Medtech

Sean Fenske and Mike Drues discuss the topic of hospitals reporting medical device incidents and what needs to change with the process.
Sean Fenske, Editor-in-Chief 03.30.17
Real World Evidence—Mike on Medtech

Sean Fenske and Mike Drues delve into the use of real world evidence in medtech regulatory approval processes and what matters to manufacturers.
Sean Fenske, Editor-in-Chief 02.24.17
NeoChord Passes 500 Patient Treatment Milestone

Two-year clinical data shows sustained outcomes in patients treated with the NeoChord System.
Business Wire 11.10.16
Contract Manufacturing | R&D & Design | Software & IT | Testing

Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA

In August, the FDA released guidances offering insight on what changes need to be reported to the agency.
Sean Fenske, Editor
Contract Manufacturing

Mike on Medtech: FDA's Additive Manufacturing & 3D Printing Guidance

On this debut episode, MPO Editor Sean Fenske and regulatory guru Mike Drues examine the recently released guidance.
Sean Fenske, Editor
Video Interview: Tips for Ensuring Supplier Quality in an Era of Consolidation

Michael Drues, Ph.D., president of Vascular Sciences, talks quality at MPO Summit 2015.