Top

Tag: medical device


Industry Focus Areas, Medical

The top medtech trends in 2024

January 31, 2024

Via: MedTech Dive

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, […]


Industry Focus Areas, Medical

FDA extends pandemic-era policy allowing certain device, production changes without prior approval

November 2, 2023

Via: MedTech Dive

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 […]


Industry Focus Areas, Medical, News

Boston Scientific Q1 sales top expectations on ‘healthy’ market demand

April 26, 2023

Via: MedTech Dive

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, […]


Industry Focus Areas, Medical

Medical device groups say ‘the stakes are high’ with new EtO regulations

April 11, 2023

Via: MedTech Dive

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 […]


Design & Planning, Industry Focus Areas, Medical, Process

Why medical device designers need to become more agile — and how they can do it

January 26, 2023

Via: MedTech Dive

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 […]


Industry Focus Areas, Medical

Pandemic Pressures & Their Ripple Effects on Medical Device Materials

March 30, 2022

Via: Design News

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 […]


Industry Focus Areas, Medical

Improving efficiency in medical device manufacturing

March 9, 2022

Via: Manufacturing Tomorrow

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 […]


Design & Planning, Process

Preparing Your Manufacturing Business for Natural Disasters

January 18, 2022

Via: Design News

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 […]


Industry Focus Areas, Medical, Process, R & D

Need the Perfect Medical Device or a New Bone? Try 3D Printing

August 30, 2021

Via: Design News

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 […]


Industry Focus Areas, Medical, Regulations

Industry pitches FDA 26% rise in user fee funding in MDUFA V negotiations

August 18, 2021

Via: MedTech Dive

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 […]


Industry Focus Areas, Medical

Medtech funding surges with early-stage deals

July 20, 2021

Via: MedTech Dive

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, […]


Design & Planning, Industry Focus Areas, Medical, Process

Medical design and manufacture news roundup

June 2, 2021

Via: Today's Medical Developments

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 […]


Industry Focus Areas, Medical, Regulations

EU plans to impose additional regulations on medtech AI products, other ‘high-risk’ systems

May 12, 2021

Via: MedTech Dive

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 […]


Industry Focus Areas, Logistics, Medical, Process

Global Medical Device Industry Bolstering Outstanding Growth Potentials

February 11, 2020

Via: PR Newswire

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… […]


Industry Focus Areas, Medical

Aethlon Medical Announces $3.77 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

January 17, 2020

Via: PR Newswire

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 […]


Industry Focus Areas, Medical

Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update

November 1, 2019

Via: PR Newswire

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 […]


Industry Focus Areas, Medical

6 medical device news stories to watch in 2019

January 29, 2019

Via: Mass Device

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 […]


Industry Focus Areas, Logistics, Medical, Process

Abbott misses Wall Street expectations on Q4 sales

January 23, 2019

Via: Mass Device

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 […]


Regulations

House tax bill would delay medical device tax by another 5 years

December 11, 2018

Via: Mass Device

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 […]


Industry Focus Areas, Logistics, Medical, Process

Abbott’s Q2 results top estimates, medical device sales up 11%

July 18, 2018

Via: Mass Device

Abbott (NYSE:ABT) today reported second-quarter results that came in ahead of the consensus expectation, with its medical device division posting sales growth of more than 11%, and raised its earnings outlook for the rest of the year. The Chicago-area healthcare […]