Tag: medical device

July 16, 2024

Ensuring the highest standards of quality is paramount in medical device manufacturing. No matter the healthcare specialty or the size and complexity of the project, operational excellence plays a pivotal role in achieving and maintaining superior quality across all stages […]

January 31, 2024

The medical device industry is set up for an eventful year after weathering numerous challenges for the past four years due to the COVID-19 pandemic and other macroeconomic factors. Last year, device companies found some stability as those pressures eased, […]

November 2, 2023

The guidance, first issued in May 2020, was supposed to expire at the end of the public health emergency. The policy allowed for any required production process changes, like social distancing, or manufacturing changes due to supply chain shortages, which […]

April 26, 2023

Boston Scientific reported first-quarter sales that exceeded the company’s forecast, saying it gained market share across its businesses as demand for procedures using its medical devices rebounded from a year ago. The company raised its full-year sales and profit forecasts, […]

April 11, 2023

Medical device trade groups raised concerns about the capacity to sterilize medical devices in response to proposed ethylene oxide regulations by the Environmental Protection Agency. The EPA seeks to reduce emissions of the gas, which it says can cause cancer […]

January 26, 2023

As medical device companies strive to remain competitive and agile in today’s fast-paced world, they must center manufacturing in business optimization plans while embracing a design-to-value approach from the start. The COVID-19 pandemic accelerated the healthcare industry’s transformation, driving faster […]

March 30, 2022

Navigating FDA’s strict and ever-changing regulatory requirements is far from a new balancing act that medical device manufacturers face daily. But the many pressures born from the pandemic, such as supply chain disruption coupled with the stringent regulatory environment, have […]

March 9, 2022

At the Medical Expo MD&M West 2022 at booth 3097 (April 12 – 14, 2022, in Anaheim, CA, U.S.A.), Kistler will showcase its broad range of process monitoring and measurement solutions for medical device manufacturing. Visitors will be able to […]

January 18, 2022

In 2017, Medtronic was significantly impacted by multiple natural disasters all in the same fiscal quarter, but managed to weather those disasters by bending, not breaking. While we have not seen any reports yet of any medical device manufacturers being […]

August 30, 2021

From hearing aids to customized prosthetics and face shields, 3D printing has changed the medical industry for the better. Not only is 3D printing accelerating the development of medical devices, but additive manufacturing has also enabled the customization of medical […]

August 18, 2021

The public meetings from MDUFA V negotiations held earlier in the year touch on the question of how much user fee funding FDA will receive without providing a figure. Industry has now reportedly put the figure at $1.2 billion, opening […]

July 20, 2021

The global healthcare sector attracted equity investment throughout the pandemic, and it is still pouring in. The April-to-June period marked the seventh straight quarter of increased funding, which reached $34.7 billion across nearly 1,600 deals in the period. Last year, […]

June 2, 2021

Tekni-Plex Medical is launching a Prototype Solutions Services initiative to support medical device manufacturers at the design stage of new tubing products used in critical fluid-transfer applications. The prototypes created as part of the service are instrumental for testing tubing […]

May 12, 2021

The European Union is advancing artificial intelligence regulations that could impact medical device and diagnostic companies around the world. Through the policy, the EU plans to impose additional requirements on the use of AI in medtech and issue fines for […]

February 11, 2020

PALM BEACH, Florida, Feb. 11, 2020 /PRNewswire/ — There is no doubt that the global medical device market has been showing outstanding growth for the last few years and that it will continue to do so in the near future… […]

January 17, 2020

SAN DIEGO, Jan. 17, 2020 /PRNewswire/ — Aethlon Medical, Inc. (Nasdaq:AEMD) (the “Company”), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, today announced that it has entered into definitive agreements […]

November 1, 2019

Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, today reported financial results for its second quarter ended September 30, 2019 and provided an update on […]

January 29, 2019

With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in […]

January 23, 2019

Abbott (NYSE:ABT) stock is down about 2% at the opening of trading today after its fourth-quarter sales failed to meet analyst expectations. The Abbott Park, Ill.–based maker of medical device, pharmaceutical, nutrition and diagnostics products brought in about $7.765 billion […]

December 11, 2018

A bill to extend this year’s tax cuts would also put a five-year moratorium on the medical device tax enacted as part of the Affordable Care Act. Although the 2.3% levy on prescribed medical devices was enacted as part of […]