Medical Product Outsourcing

PiSA Launches U.S. Sales Organization

Also adds Marie O’Malley and Jerry O’Connor to U.S. leadership team.

PiSA USA 07.15.21

Foxx Life Sciences Appoints SVP of Global Sales and Business Development

Mark Robillard brings industry knowledge and experience in all facets of the life science tools industry.

Foxx Life Sciences 12.01.20

Pandemic Expected to Drive Over-the-Counter Sales of Pulse Oximeters

Interest in pulse oximeters for COVID-19 management began to spike in early March.

GlobalData 07.14.20

Applied Plastics Appoints VP of Sales and Marketing

Michael Brown brings over 15 years of medical device industry experience.

Applied Plastics 06.30.20

West-Tech Materials Merges with Diablo Sales & Marketing

Creates a new force in the medical device market.

West-Tech Materials 06.29.20

Surgical

FDA Update on Essure Postmarket Activities

All unused Essure devices of which Bayer is aware have been returned to the company.

U.S. Food and Drug Administration 04.27.20

Materials

Plastics and Medtech: Annual Industry Survey Results

Medical device manufacturers prefer domestic plastics manufacturing and many use thermoforming on a project.

Online Exclusives Jason Middleton, Vice President of Sales & Development, Ray Products 04.24.20

Diagnostics

Enzo Biochem Launches COVID-19 Diagnostic Test

Proprietary molecular diagnostic kits offer improved scale, throughput, and sensitivity.

Business Wire 04.23.20

FDA Further Eases Burden on N95 Manufacturers

Nevertheless, demand for face masks continues to outstrip supply.

GlobalData 04.21.20

Diagnostics

bioMérieux Revenue Will Continue to Grow, Says GlobalData

New COVID-19 respiratory panel test is currently in development.

GlobalData 04.20.20

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

R&D & Design

Smaller Businesses Beget Better Innovation

Despite their global sales reach, large firms tend to focus on nurturing existing product lineups.

Online Exclusives Michael Barbella, Managing Editor 04.16.20

Neurological

FDA Approves Axonics' Next-Gen Implantable Neurostimulator

Decreases recharge interval to once a month.

Business Wire 04.14.20

Diagnostics

BD Gains Second EUA for CE-Marked Molecular Diagnostic Test

New test uses BD Max System to augment supply from existing collaborations; test results in under three hours.

BD 04.13.20

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

3M Files Lawsuit Alleging N95 Price Gouging in NYC

Defendant offered to sell $45m in N95 respirators to NYC officials at prices 500-600 percent over 3M list price.

Business Wire 04.13.20

Embracing the ‘Amazon Effect’ to Improve Financial Health

Healthcare product suppliers can improve their image to customers through automated, easy-to-use transactional utilities.

Online Exclusives Mitchell Rose, SVP and GM, Corporate Segment, Billtrust 04.08.20

ZVerse Working to Produce 20 Million Face Shields

Small digital manufacturing company pivots to support COVID-19 response.

Globe Newswire 04.08.20

Pentax Medical to Pay $43 Million Over Misbranded Endoscopes

Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.

U.S. Department of Justice 04.08.20

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

monARC Bionetworks CEO Joins Glooko as Chief Operating Officer

Company also recruits LexisNexis Health Care executive for chief commercial officer job.

Glooko 04.07.20

Diagnostics

Co-Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Test

Company's technology targets the virus's RdRp gene.

PR Newswire 04.06.20

The U.S. May Not Be Able to Purchase More N95 Respirators from 3M

According to GlobalData, 3M may have lost control of its distributor system.

GlobalData 04.03.20

Mack Molding Names Vice President of Business Development

Company also has added positions and/or promoted workers in quality, business development, customer management, manufacturing, purchasing and human resources.

Mack Molding 04.02.20

Diagnostics

Biomerica Working With N.Y. Medical School on COVID-19 Antibody Test

Once developed and scaled-up, the company’s existing production capacity could allow for more than 1 million tests per month.

Globe Newswire 04.02.20

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

The Economics of a Sound Regulatory Strategy

While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.

Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20

The Need for Extraordinary Leadership During a Crisis

During these unprecedented times, there have been numerous examples of leadership, both good and bad, from various sources.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 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

Former Boston Scientific Marketing Director Joins CorWave Board

New board member also worked for Medtronic and Avedro.

Business Wire 04.01.20

Prent Supports the Fight Against COVID-19

The company is manufacturing and donating face shields.

Prent Corporation 03.30.20

Diagnostics

Hardy Diagnostics Releases Rapid Test for COVID-19

Partnership with Autobio Diagnostics enables company to become a U.S. supplier of one-step lateral flow assay that detects both IgG and IgM antibodies.

Newswire 03.25.20

Probo Medical Acquires Elite Medical Technologies and Future Medical Equipment

Elite Medical is a U.S.-based wholesale reseller of pre-owned digital medical imaging equipment.

Business Wire 03.25.20

Moody's: Medical Device Earnings Forecast Decreased Based on Lower Sales

Companies will increase investment in research and development in order to maintain or enhance revenue growth.

Moody's Investors Service 03.18.20

Qosina Provides Business Update Regarding COVID-19

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Getinge Increases Ventilators Production Capacity

To meet the global demand, the company will temporary increase its production of ventilators by 60 percent in 2020 compared to 2019.

Getinge 03.17.20

Ra Medical Systems Appoints New CEO

Will McGuire most recently served as president and CEO of Second Sight Medical Products.

Business Wire 03.13.20

Electronics

TE Connectivity Acquires Majority Share of First Sensor AG

The firm now holds 71.87 percent shares of First Sensor.

TE Connectivity 03.12.20

Intact Vascular Expands Tack Endovascular System Portfolio Offering

New larger implant enables focal dissection repair across a wider range of vessel sizes.

Business Wire 03.09.20

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

Lantheus Holdings Appoints Chief Commercial Officer

New hire has extensive healthcare industry experience, as well as knowledge of sales and marketing.

Business Wire 03.05.20

R&D & Design

Four Considerations for Developers of Next-Generation Combination Products

Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.

Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20

Software & IT