Medical Product Outsourcing

Telemedicine, Regulatory Changes to Characterize Medtech Industry in 2021

The global pandemic has created an urgent need for telemedicine.

GlobalData 01.19.21

LivaNova Announces Board Changes

Update includes the appointment of a new member as well as board leadership changes.

Business Wire 12.07.20

Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.

Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 11.04.20

Cardiovascular

Coverage Policy Changes for Ventricular Assist Devices to Impact Heart Failure Product Market

Proposed CMS changes will preserve patient access for all labeled VADs currently on the market.

GlobalData 10.06.20

An Update on the 2020 Presidential Election and Recent Regulatory Changes

The 2020 presidential election is heating up as both parties held their national conventions in late August.

Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 10.01.20

Contract Manufacturing

So Many Changes in Medtech, So Short a Time

This article looks at the general state of medtech/life sciences M&A and the outsourcing trends triggered by the worldwide COVID-19 pandemic.

Mark Bonifacio, President, BCS LLC 10.01.20

Dynamic Organizational Changes to Succeed in the New Normal

Medtech executives must adapt to managing their businesses in a substantially different environment.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 07.21.20

Recent Regulatory Changes and a 2020 Election Update

As COVID-19 continues to impact the country, legislators and policy makers in Washington are keenly focused on the upcoming national election on Nov. 3.

Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker, and Matteson L. Beckis, Jeffrey J. Kimbell & Associates Inc. 07.21.20

Health Canada Authorizes Gas Exchange Monitor for COVID-19 Use

Device is used to rapidly assess a patient's respiratory status, non-invasively.

PR Newswire 04.29.20

MDR Delay Official; Industry Urges Push Back of IVDR

European Council voted 27-0 to adopt amendment delaying MDR application by one year due to COVID-19 pandemic.

MedTech Europe 04.24.20

FDA OKs Baxter's Oxiris Blood Purification Filter for COVID-19 Treatment

Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood.

Baxter 04.24.20

Non-Traditional Thinking Can Help Drive Medtech R&D

Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.

Online Exclusives Michael Barbella, Managing Editor 04.21.20

FDA Continues User-Fee Related Reviews Through COVID-19

FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.

U.S. Food and Drug Administration 04.17.20

3D/Additive Manufacturing | Diagnostics

3D-Printed Swabs Could Help Fill Gap in COVID-19 Test Kits

Clinical trials expected to begin by the end of this week.

University of Louisville 04.17.20

AptarGroup Seeking Emergency Authorization for Easy Mask Disinfection Process

Process takes three hours and can be performed on-site at hospitals.

AptarGroup Inc. 04.17.20

HeartVista Forms Medical and Scientific Advisory Board

Governing body comprised of leaders from Stanford University and the University of Wisconsin.

Business Wire 04.16.20

Tolomatic Develops Open-Source, Ventilator Actuation Prototypes

The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.

Tolomatic 04.13.20

Chronic Disease | Digital Health

One Drop Acquires Health Sensing Firm Sano

Sano continuous glucose sensing platform will live on in a comprehensive multi-sensorial solution from One Drop.

PR Newswire 04.13.20

COVID-19 is Exposing the Fragility of Global Supply Chains

Pandemic likely will prompt healthcare companies to reshape supply chains to strengthen the risk management process and resilience.

GlobalData 04.13.20

EnClear Therapies Announces $10 Million in Series A Financing

Company also adds three to its Board of Directors.

Business Wire 04.09.20

Zimmer Biomet CEO Foregoing Salary During COVID-19 Crisis

Bryan Hanson's salary forfeit is among many steps the company is taking to contain costs amid the pandemic.

Zimmer Biomet 04.07.20

Software & IT

Veeva Announces Alliances for Digital Field Engagement

Veeva to design digital strategies and implementation road map to help field teams better connect with HCPs.

Veeva 04.07.20

Qosina Is the Trusted Provider of Single-Use Bioprocessing Components

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PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables

Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.

PhysIQ 04.07.20

Neurological

StimGuard Changes Name to Micron Medical; Appoints New CEO

Stephen Deitsch was most recently CFO of publicly-traded BioScrip Inc.

GlobeNewswire 04.06.20

Diagnostics

Ortho Clinical Diagnostics Releases COVID-19 Antibody Test

Testing kits are expected to be available in a few weeks.

PRNewswire 04.06.20

The Challenge and Opportunity in Corporate Environmental Sustainability Efforts

One company shares its experiences and outcomes with ongoing efforts toward a focus on environmental stewardship.

Neil Peterson, Alisha Jerauld, CPA and Matt Wold, Merit Medical Systems Inc. 04.01.20

Software & IT

Validating Your QMS the ‘EZ Way’

Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.

James Shore and Roxana Rosales 04.01.20

Digital Health

Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

Michael Barbella, Managing Editor 04.01.20

Tubing & Extrusion

Pathways to Care: Tubing Technologies

Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.

Mark Crawford, Contributing Writer 04.01.20

Diagnostics

Gaining a Clearer Picture of Hitachi

Diagnostic imaging is gaining the attention of many in healthcare as the technologies shrink in size and become available to those outside the hospital.

Sean Fenske, Editor-in-Chief 04.01.20

R&D & Design

Top 10 Considerations for Medtech Inventors

If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.

Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20

Medtech Innovation and Adaptation in a Changing Pharmaceutical Landscape

The two primary industries driving healthcare innovation—pharmaceutical and medtech—are intrinsically intertwined.

Tom McLean, VP, Development Engineering, R&D Innovation & Technology, West Pharmaceutical Services 04.01.20

COVID-19’s Impact on the Medical Device Supply Chain

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Tony Freeman, President, A.S. Freeman Advisors LLC 04.01.20

COVID-19’s Lasting Impact on Healthcare’s Supply Chain

While some have speculated about what will happen after this passes, the one area that most interests me is the medical device and healthcare supply chains.

Sean Fenske, Editor-in-Chief 04.01.20