Manufacturing
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By Matt Singer • Oct. 08, 2019 -
Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities
The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
By David Lim • Sept. 30, 2019 -
EPA delays ethylene oxide sterilizer rule timeline amid industry pushback
Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published.
By David Lim • Sept. 25, 2019 -
FDA warns closure of Atlanta Sterigenics facility could impact medical device supply
Sterigenics said it aims to complete construction of technology upgrades at the plant, designed to reduce ethylene oxide emissions, by early October.
By David Lim • Sept. 16, 2019 -
FDA sets November ethylene oxide sterilization, duodenoscope safety advisory panel
The dual-topic expert panel will be tasked with developing recommendations for FDA on two of the largest challenges currently facing the Center for Devices and Radiological Health.
By David Lim • Sept. 03, 2019 -
Medline, Vantage ethylene oxide emissions caused cancer, lawsuits claim
Commercial sterilizer Sterigenics, which was forced to shut down a Willowbrook medical device sterilizing plant in February, is defending itself against at least 32 lawsuits in the same state court over similar claims.
By David Lim • Aug. 29, 2019 -
Sterigenics strikes deal to reopen Willowbrook sterilization plant
The closure of the Illinois facility caused millions of dollars of losses for major medical device firms like Medtronic, Boston Scientific and Smiths Medical.
By David Lim • UPDATED: Sept. 9, 2019 at 10:41 a.m. -
FDA launches innovation challenge to boost ethylene oxide sterilization alternatives
The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization.
By David Lim • July 16, 2019 -
Baxter to expand home dialysis on heels of Trump kidney initiative
Amid a push to move away from costly dialysis centers, Baxter said it expects to add and bolster facilities for making and distributing peritoneal dialysis solutions, devices and cassettes.
By Maria Rachal • July 11, 2019 -
FDA hits Clinicon with warning letter over sterility failings
Inspectors found fault with the validation and calibration of processes and equipment involved in ensuring sterility of laser devices.
By Nick Paul Taylor • July 11, 2019 -
Amazon's momentum in medical supply chain slowing, poll finds
A UBS survey of hospital purchasing managers found providers are allocating purchases of surgical tools, orthopaedic and cardiology implants, and other medical supplies to Amazon at a lower rate this year compared to 2018.
By Rebecca Pifer • July 10, 2019 -
Deep DiveLooming EPA ethylene oxide rules hang over device supply chain
The medical device industry is lobbying Capitol Hill and statehouses, warning limited access to the sterilant could pose deadly disruptions.
By David Lim • June 25, 2019 -
B. Braun invests $1B in IV fluid manufacturing to alleviate shortages
FDA's task force on drug shortages is expected to submit a report to Congress by year's end outlining potential solutions to address root causes of scarcities.
By David Lim • May 15, 2019 -
Haemonetics sells plant, gains expanded indication for blood analyzer systems
After reporting a 6.7% jump in quarterly revenue, the blood technologies maker has offloaded a manufacturing site to CSL Plasma and received clearance for use of its hemostasis analyzer system in adult trauma settings.
By Susan Kelly • May 15, 2019 -
Medical equipment hit by escalation of US-China trade war
Between tariffs already enacted and an additional $300 billion in products on the table, imaging equipment, diagnostic reagents, surgical gloves and contact lenses stand to be among the medical devices affected.
By Nick Paul Taylor • May 15, 2019 -
FDA floats 5-day notice for device inspections in draft guide
The agency is filling an obligation under the FDA Reauthorization Act of 2017 to adopt uniform standards around not-for-cause inspections.
By David Lim • March 29, 2019 -
Accenture to buy Irish manufacturing services firm ESP
ESP will join Accenture's digitally-focused unit and bring along its clients, which include Stryker and Boston Scientific.
By Kristin Jensen • March 07, 2019 -
Trump light on trade details in State of the Union address
The President's comments on trade were short and direct, calling for passage of the United States-Mexico-Canada Agreement (USMCA) and the lesser-known Reciprocal Trade Act.
By Emma Cosgrove • Feb. 05, 2019 -
Thermo Fisher posts 16% yearly sales growth, 7% specialty diagnostics bump
Some analysts sought more bullish 2019 goals. But company executives are waiting to see how Brexit, the U.S. trade war with China and other tariffs play out.
By Maria Rachal • Jan. 30, 2019 -
Senate Democrats question Gottlieb on FDA shutdown impact
FDA Commissioner Scott Gottlieb wrote Tuesday on Twitter the agency has returned 100 inspection staff to work to oversee high-risk medical device facilities.
By David Lim • UPDATED: Jan. 16, 2019 at 8:48 a.m. -
Pharma DTC spending outpaces rest of medical marketing, JAMA study finds
Total spending on marketing for prescription drugs, disease awareness campaigns, health services and laboratory tests by the health industry totaled $29.9 billion in 2016, up 60% from $17.7 billion in 1997.
By Andrew Dunn • Jan. 07, 2019 -
Deep DiveWhat's in a connected medical device? Cybersecurity regulators want to know
FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.
By Meg Bryant • Jan. 03, 2019 -
Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018
Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.
By Maria Rachal • Dec. 22, 2018 -
Smith & Nephew completes meniscus repair acquisition
The company said Tuesday its $50 million purchase of Ceterix Orthopaedics has closed, with additional payouts up to $55 million possible over the next five years based on the associated meniscal repair system's financial performance.
By Maria Rachal • UPDATED: Jan. 23, 2019 at 10 a.m. -
FDA outlines fast track vision for breakthrough devices
The agency also announced plans to establish a pathway for devices aimed at treating non-life-threatening diseases not eligible for the original program.
By David Lim • Dec. 18, 2018
