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Tag: medical devices


Industry Focus Areas, Medical

Acutus laying off 65% of employees to focus solely on Medtronic heart device deal

November 10, 2023

Via: MedTech Dive

Acutus developed mapping technology to try to reduce the rate of atrial fibrillation recurrence after patients undergo ablation. The company pitched its non-contact approach to mapping as a better fit for atrial fibrillation and other complex or unstable arrhythmias, but […]


Industry Focus Areas, Medical, Regulations

FDA hits iRhythm with warning letter over problems at heart monitor facility

June 1, 2023

Via: MedTech Dive

FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed […]


Process, Production

Molex Expands Vietnam Manufacturing Plant

September 30, 2022

Via: Manufacturing Tomorrow

Molex, a global electronics leader and connectivity innovator, today announced it is expanding its existing manufacturing operations in Hanoi to include a new 16,000 square meter facility. The company expects the expansion will support over 200 new jobs in advanced […]


News

Boston Scientific managed COVID-19, economic pressures in Q2, expects procedures to increase

July 27, 2022

Via: MedTech Dive

Boston Scientific weathered ongoing COVID-19 and macroeconomic pressures in the second quarter, leading the company to raise its 2022 forecast for organic revenue growth. CEO Michael Mahoney said on a Wednesday earnings call that the company now expects more “durable […]


Industry Focus Areas, Medical, Regulations

As Senate passes $280 billion measure to bolster U.S. chip production, medtech industry applauds

July 27, 2022

Via: MedTech Dive

The U.S. medical device industry hailed the Senate vote today to appropriate $280 billion over several years to increase domestic production of computer chips, including a special fund to ensure the production of older generation chips used in many medical […]


Industry Focus Areas, Medical

Advancements in wearable medical devices, now and into the future

December 29, 2021

Via: Today's Medical Developments

The global wearable medical device market size is projected to grow at a 19.5% compound annual growth rate from $17.4 billion in 2020 to $56.6 billion by 2030, according to a report by Market Watch. The evolution of home healthcare […]


Process, R & D

Industry 4.0 – Smart cutting tools an essential part of 21st Century manufacturing

November 5, 2021

Via: Today's Medical Developments

Industry 4.0 and the Industrial Internet of Things (IIoT) are driving today’s manufacturing, combining physical production and operations with smart digital technology. With a heavy focus on interconnectivity, automation, machine learning, real-time data utilization, and artificial intelligence (AI), Industry 4.0 […]


Industry Focus Areas, Medical

MedTech Innovator finalists vie for $500K in 9th annual competition

September 24, 2021

Via: Today's Medical Developments

MedTech Innovator, the largest accelerator of medical devices in the world, announced that Alva Health, BioDevek, Caretaker Medical, Cooler Heads Care, and Nutromics have been selected as finalists out of 1,100 applicants to compete for the title of MedTech Innovator […]


Industry Focus Areas, Medical, Regulations

As EU-wide health technology oversight law nears passage, industry is not pleased

July 6, 2021

Via: MedTech Dive

HTA bodies are best known for their assessments of the value of new medicines, which can lead to countries choosing not to pay for approved products. Some of the bodies also play a role in assessing the value of new […]


Industry Focus Areas, Medical

FDA rejects Verily filing for wrist-worn Parkinson’s clinical trial device

June 14, 2021

Via: MedTech Dive

In recent years, FDA has cleared Verily’s Study Watch for use as an electrocardiogram and as an irregular pulse monitor via its 510(k) pathway. Verily followed up by filing to use the device as a drug development tool for Parkinson’s […]


Industry Focus Areas, Logistics, Medical, Process

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

June 1, 2021

Via: MedTech Dive

The Center Devices and Radiological Health budget has increased quickly in recent years, rising from $480 million in 2018 to $628 million in 2021. Increased user fees played a big part in that four-year rise, growing approximately 49% over the […]


Industry Focus Areas, Medical, Regulations

5 things medtech can expect from FDA in 2021

March 15, 2021

Via: MedTech Dive

To say that 2020 was a challenging year for FDA would be an understatement. The COVID-19 pandemic stretched resources thin as it grappled with unprecedented regulatory demands as a result of the U.S. public health emergency. FDA’s response to the […]


Process, Production

Why Should China Make Everything?

January 4, 2021

Via: The New York Times

The panic in the United States over the lack of masks and ventilators for Covid-19 has mostly eased, but please, don’t let those scary few weeks fade too quickly. The scramble for medical equipment was a telling moment for the […]


Industry Focus Areas, Medical

Cleanrooms in Medical Manufacturing

October 16, 2020

Via: Industry Today

The medical industry needs supplies devoid of harmful pathogens. Medical devices, such as retractors, urinary catheters, face masks for oxygen administration, and single-use anoscopes, should provide care without adding risks to patients and other users. Hence, it’s essential to have […]


Industry Focus Areas, Medical, Regulations

Tinker, tailor, robot maker: In China, trade war threat casts long shadow

May 4, 2018

Via: Reuters

Those plans are now under threat. The robots, which help develop cell cultures used in stem cell therapies, are on a sprawling list of products threatened with steep U.S. tariffs amid a simmering trade stand-off between Washington and Beijing. The […]


Industry Focus Areas, Medical

FDA suggests controls on interoperable devices

December 12, 2017

Via: Mass Device

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between […]


Industry Focus Areas, Medical

Philips gains on strong Q2 results

July 24, 2017

Via: Mass Device

Royal Philips (NYSE:PHG) shares are up today after the Dutch healthcare conglomerate said core second-quarter profits rose nearly 15% to $512.31 million (€439 million), just beating the consensus forecast. The Amsterdam-based company, which spun off its lighting division last year to focus […]


Industry Focus Areas, Medical

Orthofix Q1 sales beat the Street, EPS narrowly misses

May 5, 2017

Via: Mass Device

Orthofix (NSDQ:OFIX) shares have stayed steady in after hours trading today after the medical device maker topped sales expectations but narrowly missed EPS consensus with its 1st quarter earnings results. The Lewisville, Texas-based company posted losses of $2.7 million, or 15¢ […]


Industry Focus Areas, Medical

Dermal device dev Luma Therapeutics raises $2m

February 16, 2017

Via: Mass Device

Psoriasis treatment device developer Luma Therapeutics raised $2 million in a new round of equity financing, according to an SEC filing posted this week. The company is developing the Luma Therapeutics System, designed to treat psoriasis through a “combination of […]


Industry Focus Areas, Medical, Process, Quality Control

ECRI lists the top 10 medical device hazards

November 9, 2016

Via: Mass Device

The ECRI Institute this month released its top 10 health technology hazards for the next year, with Infusion errors and inadequate cleaning of reusable instruments topping the list. The ECRI institute is a nonprofit dedicated to analyzing and researching which […]