Medical Devices: Page 145
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FDA patient advisory meeting set to tackle cybersecurity in devices
The September meeting will partly focus on how healthcare providers should best communicate cybersecurity risks to medical device users.
By Susan Kelly • July 3, 2019 -
CMS extends ambulatory blood pressure monitoring coverage
In a change, patients with masked hypertension will be eligible for testing.
By Nick Paul Taylor • July 3, 2019 -
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
International Trade Commission probes Intuitive imports following J&J complaint
The ITC began the investigation after J&J's Ethicon argued certain Intuitive stapler cartridges infringe its patents.
By Nick Paul Taylor • July 3, 2019 -
Varian, Boston Scientific seal the deal on beads business transfer
Varian Medical Systems said Wednesday it completed the $90 million purchase of Boston Scientific's drug-loadable microspheres and bland embolic beads, a transaction key to Boston Scientific's buyout of BTG finalized Monday.
By Maria Rachal • Updated Aug. 21, 2019 -
Jacob Bell
FDA finalizes rule on requesting review of CDRH decisions
The agency declined an AdvaMed request for additional time to seek supervisory review after a company receives details of a significant decision.
By David Lim • July 2, 2019 -
Ruptured Edwards balloons linked to 3 patient deaths
FDA revealed there have been 22 complaints related to rupture or puncture of an intra-aortic occlusion device, which can put patients at risk of complications like embolism, neurological damage and stroke.
By Nick Paul Taylor • July 2, 2019 -
Military-focused abdominal trauma foam earns FDA breakthrough status
The agency awarded the designation to Critical Innovations, a company developing technologies for individuals injured in combat.
By Susan Kelly • July 1, 2019 -
Boston Scientific says Watchman more cost effective than drugs for AFib
In the Journal of the American Heart Association, researchers examined long-term data pooled from the Protect AF and Prevail clinical trials of the company's Watchman device for stroke prevention in atrial fibrillation patients.
By Susan Kelly • July 1, 2019 -
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Trump: US won't impose tariffs on $300B Chinese goods 'for the time being'
Existing 25% tariffs on $250 billion of Chinese goods, along with China's retaliatory tariffs, will remain in place.
By Shefali Kapadia • June 29, 2019 -
Interagency workshop to focus on device interoperability
The Health Information Technology Research and Development Interagency Working Group is seeking feedback from industry, academia and government experts on potential solutions for creating interoperable systems.
By Susan Kelly • June 28, 2019 -
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Hologic promotes replacement to head diagnostics unit
Kevin Thornal, who is currently the president of the company's medical aesthetics division, will become the president of its diagnostics unit.
By Nick Paul Taylor • Updated July 22, 2019 -
Medtronic
Medtronic insulin pump recall lands in FDA's top risk category after cybersecurity warning
The Class I determination follows an FDA warning in June that a hacker could dangerously tamper with insulin dosing. As of Tuesday, the agency is unaware of any cases of patient harm stemming from the vulnerability.
By Nick Paul Taylor • Updated Nov. 5, 2019 -
Boston Scientific touts potential of BTG buy, structural heart strategy
The medtech giant said it plans to launch roughly 75 products and achieve up to 9% organic revenue growth by 2022, not including contributions to its interventional oncology business from the yet-to-be-finalized BTG acquisition.
By Maria Rachal • June 27, 2019 -
Health Canada to mandate medical device adverse event reporting
The new regulations will force hospitals to report incidents within 30 days.
By David Lim • June 27, 2019 -
Anthem adds Teleflex's UroLift to prostate disease coverage
The benign prostatic hyperplasia update will provide 32 million people insured by Anthem access to the implant.
By Nick Paul Taylor • June 27, 2019 -
Jacob Bell / BioPharma Dive
FDA finalizes guidance on diagnostic ultrasound systems
The text hews closely to the draft the agency issued in 2017, the core of which detailed its policy on 510(k) filings.
By Nick Paul Taylor • June 27, 2019 -
US medtech market forecast to top $200B by 2023
The prediction from Fitch Solutions is based on trends like an aging population with a rising incidence of chronic disease and certain regulatory changes.
By Nick Paul Taylor • June 26, 2019 -
Smartphone heart data mirrors gold standard EKG in study
UCSF researchers said it was the largest analysis of real-world heart rate data remotely obtained and stratified by demographics and medical conditions.
By Nick Paul Taylor • June 26, 2019 -
Brian Tucker
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 -
Mayo Clinic to build proton therapy facility on Florida campus
A spokesperson for the health system said Mayo has not yet decided which manufacturer's proton therapy systems will outfit the planned center, set to be completed in late 2023.
By Susan Kelly • June 25, 2019 -
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Teleflex recalls more endotracheal tubes, now linked to four deaths
The devices, used to administer anesthesia and provide ventilation during surgical procedures, may become disconnected from the breathing circuit, resulting in insufficient oxygenation.
By Susan Kelly • Updated Aug. 5, 2019 -
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Final TAVR Medicare decision gets thumbs up from Edwards, Medtronic
The new policy eases volume requirements for hospitals and physicians to begin transcatheter aortic valve replacement programs but increases the number of valve procedures necessary to maintain a program.
By Susan Kelly • June 24, 2019 -
FDA ends alternative reporting program, pledges to make MAUDE user friendly
The agency disclosed more than 6 million medical device adverse event reports were filed under the controversial system since 1997.
By David Lim • June 24, 2019 -
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Label should warn patients of paclitaxel device mortality signal, FDA panel says
The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.
By David Lim • June 21, 2019 -
NIH's Collins highlights progress on 3D printed human organs
Researchers at Rice University found a way to create an open-source bioprinting technology that grows soft hydrogel scaffolds one layer at a time.
By Susan Kelly • June 21, 2019
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