FDA: Page 52
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a "sharp and rapid" drop in demand.
By Nick Paul Taylor • June 8, 2021 -
Medtronic's HVAD controversy
Medtronic's HeartWare HVAD ending brings questions about $1B acquisition
Nearly five years after Medtronic's buy of HeartWare International, the medtech giant pulled the flagship product of the deal due to safety risks, ceding the market to rival Abbott.
By Ricky Zipp • June 8, 2021 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains
CEO Geoff Martha has boasted the nod for SenSight will help it close "a key competitive gap." The medtech competes with Abbott and Boston Scientific in the market.
By Nick Paul Taylor • June 8, 2021 -
Sarah Silbiger via Getty Images
Cancer tech dominates FDA's latest batch of breakthrough devices
The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.
By Nick Paul Taylor • June 7, 2021 -
UnitedHealthcare to crack down on ER visits, potentially exposing patients to bigger bills
If the largest private payer finds the trip was not an emergency, the visit will be "subject to no coverage or limited coverage," the provider alert states. Anthem faced backlash for a similar policy several years ago.
By Samantha Liss • June 4, 2021 -
Alex Wong via Getty Images
CMS' Fowler: More mandatory payment models likely
"I recognize those come with their own set of disadvantages ... But I support this direction," CMMI head Elizabeth Fowler said Thursday.
By Rebecca Pifer Parduhn • June 3, 2021 -
Medtronic's HVAD controversy
Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths
The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.
By Ricky Zipp • June 3, 2021 -
Sarah Silbiger via Getty Images
FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities
BD and Medtronic are among those that already recalled products processed by Steril Milano, accused by the agency of falsifying graphs and parameters of sterilization certificates for a variety of products dating back to 2016.
By Nick Paul Taylor • June 3, 2021 -
Jacob Bell/MedTech Dive
Cognoa's machine learning software for autism diagnosis gets FDA nod
The software as a medical device, which uses an algorithm, reports a positive or negative diagnosis based on analyses of videos of the child and other information. The product got FDA's breakthrough designation in early 2019.
By Nick Paul Taylor • June 3, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
In first, FDA approves KRAS-blocking cancer drug from Amgen
After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.
By Ned Pagliarulo • Updated May 29, 2021 -
Sarah Silbiger via Getty Images
FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production
The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.
By Nick Paul Taylor • June 1, 2021 -
ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes
The lab trade group for Quest, LabCorp and others argues the Protecting Access to Medicare Act is a case of "harmful regulatory overreach" that forces an "unsustainable reimbursement model" on its members.
By Nick Paul Taylor • June 1, 2021 -
Swiss medtech sounds alarm as MDR erects barriers to EU market
The Swiss Medical Technology Association said the change will cost the industry it represents the equivalent of $126 million to meet new administrative requirements.
By Nick Paul Taylor • May 28, 2021 -
Joe Raedle via Getty Images
Rising hospital ransomware attacks could endanger patients, hit bottom lines hard, Moody's says
Systems have been rendered more vulnerable due to COVID-19 as more non-clinical employees work from home. The warning echos comments made recently by the FDA's cyber chief for medical devices.
By Ron Shinkman • May 27, 2021 -
Sarah Silbiger via Getty Images
FDA draft guidances lay out postmarket medical device data requirements
Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs.
By Nick Paul Taylor • May 27, 2021 -
Courtesy of Abbott, PRNewswire
HHS commits $4.8B to COVID-19 testing for the uninsured
The American Clinical Laboratory Association, with members including LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.
By Susan Kelly • May 26, 2021 -
MDR challenges remain as regulation goes into effect: MedTech Europe
The European trade group contends that while the Medical Device Regulation's May 26 effective date marks a significant milestone, hurdles limit industry’s ability to "seamlessly supply certified devices under the new rules."
By Greg Slabodkin • May 26, 2021 -
Senate confirms Chiquita Brooks-LaSure as head of CMS
AdvaMed and MDMA both called out the Medicare Coverage of Innovative Technology rule, now delayed, as a priority for the new administrator. President Joe Biden has yet to name an FDA chief.
By Rebecca Pifer Parduhn • May 25, 2021 -
Leon Neal via Getty Images
Ransomware, other cyber threats mount as medtech industry tries to adapt
"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless.
By Greg Slabodkin • May 25, 2021 -
Sarah Silbiger via Getty Images
FDA clears 2 endoscopes that avoid reprocessing
The agency, which has urged a shift to endoscopes with single-use parts or that are fully disposable, gave the OK to UroViu to market a single-use cytoscope and to China's EndoFresh for a disposable digestive endoscopy system.
By Susan Kelly • May 25, 2021 -
MDR is live. Here are 5 things to know on where the rule stands.
The device industry has resolved some near term pressures as the EU's delayed landmark regulation comes into effect, but challenges related to IVDR, Brexit and more remain.
By Nick Paul Taylor • May 25, 2021 -
Courtesy of Quest Diagnostics
Labs urge HHS to back new regulatory regime for diagnostic tests
The trade group for Quest, LabCorp and others wants the Biden administration to back legislation to create a framework for laboratory developed tests separate from medical devices.
By Susan Kelly • May 24, 2021 -
Sarah Silbiger via Getty Images
Boston Scientific recalls venous stents because of migration risk
The medtech giant is recalling all Vici SDS and Vici RDS stent systems distributed over a 30-month period after receiving 17 complaints. The FDA categorized it as a Class I recall, its most serious designation.
By Nick Paul Taylor • May 24, 2021 -
Retrieved from Official White House Photo by Adam Schultz.
Biden orders Software Bill of Materials to boost cybersecurity. AdvaMed wants uniform standards.
An executive order calls for an electronically readable way to provide an inventory of third-party components in devices. The medtech lobby backs the idea but says standardization is critical.
By Greg Slabodkin • May 21, 2021 -
Sarah Silbiger via Getty Images
FDA seeks feedback on device ingredient labeling requirements
The agency held a public meeting late in 2019 debating adding more specific information on materials used in devices with long-term exposure such as breast implants and metal-on-metal hips.
By Nick Paul Taylor • May 21, 2021
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