Manufacturing
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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 -
Hologic begins selling 3-in-1 uterine scope
The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.
By Susan Kelly • Dec. 11, 2018 -
SponsoredOil changes and knee replacements: Healthcare's shift to lower-cost care
Similar to the automotive world, healthcare is moving towards lower-cost care. What does this mean for medtech?
By Prateek Harsh • Nov. 27, 2018 -
Deep Dive3D printing poised to disrupt healthcare
Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.
By Meg Bryant • Nov. 12, 2018 -
SponsoredMedtech needs to be solutions-oriented, not product-driven
What can medtech do to differentiate when differentiation is hard to prove with products alone?
By Rohan Agni • Oct. 23, 2018 -
SponsoredLiving on a slope: Agile commercial strategies for IDN success
Why adopting an agile commercial strategy in medtech is like 'living on a slope.'
By Bret Caldwell, Principal, ZS • Sept. 25, 2018 -
FDA says Florence unlikely to cause critical device shortages
The agency is closely monitoring 10 sites that make critically important devices and biological products.
By Nick Paul Taylor • Sept. 20, 2018 -
Cook resolves FDA warning letter that slammed quality processes
The close-out letter follows four years of work to improve quality management.
By Nick Paul Taylor • Sept. 12, 2018 -
Becton Dickinson sells bioprocessing business to Thermo Fisher
Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.
By Susan Kelly • Sept. 10, 2018 -
How TraceLink will use $93M in new funds to showcase the benefits of serialization
The data network plans to expand into a life sciences software suite to help pharmaceutical supply chains tap into data that was unavailable prior to track-and-trace regulations.
By Edwin Lopez • Aug. 23, 2018 -
FDA extends EpiPen expiration date to ease shortages
Current supply issues stemming from ongoing manufacturing delays could put children at risk as the school year approaches.
By Suzanne Elvidge • Aug. 22, 2018 -
SponsoredThe end of the "Features War": The changing definition of value in Medtech
In today’s evolving hospital environment, features simply are not enough: Products must create indisputable value.
By Brian Chapman • Aug. 21, 2018 -
With Mylan reeling, Kaléo touts its EpiPen rival for back-to-school season
Manufacturing delays at a Pfizer-owned EpiPen plant have created an opportunity for Kaléo.
By Nick Paul Taylor • UPDATED: Aug. 15, 2018 at 11:47 a.m. -
Baxter boosts 2018 outlook but IV bag supply still under pressure
"We hope that by the end of the year, early next year, MINI-BAG Plus and MINI-BAG will be off allocation," Baxter CEO José Almeida told investors.
By David Lim • July 26, 2018 -
Deep DivePharma and AI? Let's try augmented intelligence first
Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.
By Lisa LaMotta • July 23, 2018 -
Industry seeks clarity on latest FDA Pre-Cert working model
A software coalition questioned the agency's statutory authority to run a pilot test in 2019.
By David Lim • July 19, 2018
