FDA: Page 98
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CMS proposes putting Durable Medical Equipment bidding on pause
Administrator Seema Verma said the agency's ideas will result in a more competitive bidding program, and an industry group initially seems pleased with the proposals.
By David Lim • July 12, 2018 -
Medtronic gets FDA approval for less-invasive LVAD
The regulatory nod gives the device giant an advantage over rival Abbott.
By Nick Paul Taylor • July 12, 2018 -
Explore the Trendlineâž”
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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 -
Medtronic, UnitedHealthcare say value-based pact cut diabetes costs
The biggest U.S. payer and largest medical device company saw encouraging results in the program's first year.
By Susan Kelly • July 11, 2018 -
Gottlieb: Investment into leveraging RWD will benefit device, drug safety
Allowing FDA to use de-identified EHR clinical medical information would boost safety monitoring and shift more development to a post-market setting, the FDA commissioner said.
By David Lim • July 11, 2018 -
New body to improve patient EHR matching advised by experts
Advisers convened by Pew want the entity to create best practices and standards to better link patients to health records.
By Nick Paul Taylor • July 11, 2018 -
Better cybersecurity safeguards urged for medical devices, EHRs
A congressional panel issued a request for information on how to improve cybersecurity in the medical device sector, amid concerns that older “legacy” technologies may be more vulnerable to security threats than their modern counterparts.
By Susan Kelly • July 10, 2018 -
US imposes 25% tax on $836M in Chinese medtech imports
The extent of the tariffs represent a minor victory for the medtech industry, which lobbied to bring the value of products covered by the levy down from nearly $3 billion.
By Nick Paul Taylor • July 10, 2018 -
Data-sharing site seeks to battle underground chemists in opioid fight
US agencies are teaming with the German government to help forensic chemists share data on new drug variants.
By Susan Kelly • July 9, 2018 -
FDA pledges 'efficient regulation' of mobile health apps
The agency hopes to launch its software precertification program next year.
By Meg Bryant • July 5, 2018 -
Drug, device companies gave docs, teaching hospitals $8.4B in 2017
The amount includes $2.82 billion for non-research payments, such as meals, fees and travel to speaking events.
By Les Masterson • July 3, 2018 -
CMS seeks input on Stark Law changes amid value-based care shift
The American Hospital Association has been vocal in pushing for changes to the physician self-referral law, calling it outdated.
By David Lim • June 21, 2018 -
FDA unveils software Pre-Cert update
The agency hopes to finalize the working model by the end of the year and launch a large-scale pilot program in 2019.
By Meg Bryant • June 21, 2018 -
FDA to launch medical device 'innovation challenge' to combat opioid crisis
The agency is dangling its Breakthrough Device designation to spur products, including diagnostics to identify those at high risk of addiction and pain.
By David Lim • May 31, 2018 -
FDA lays out next steps for Pre Cert pilot
Nine companies are taking part, including Apple, Fitbit and Johnson & Johnson. The program aims to reduce certification checkpoints for software companies for low-risk software-based medical devices.
By David Lim • April 27, 2018 -
CMS pushes hospitals to post prices online
A sweeping 1,800-page proposed rule also would eliminate 25 quality measures across five programs with an aim to ease administrative burden and improve EHR interoperability.
By Jeff Byers , David Lim , Tony Abraham • Updated April 25, 2018 -
Industry blasts FDA Clinical Decision Software draft
A group that includes software providers, medical device makers and drugmakers says that if implemented, the draft guide would "force many sellers of existing CDS software to remove their products from the market."
By David Lim • Feb. 7, 2018 -
FDA lays out digital health goals in 2018 strategic roadmap
The agency will continue to build out its Pre-Certification Pilot Program to help encourage the development of digital health tools.
By David Lim • Jan. 12, 2018 -
Deep Dive
Latest MACRA, doctor fee rules could bring boost to telehealth, wearables
“This is a big step forward for Medicare’s ability to deal with chronic conditions," American Telemedicine Association's Gary Capistrant says of an unbundled payment code for remote patient monitoring.
By Meg Bryant • Dec. 14, 2017 -
4 out of 5 US physicians have experienced a cybersecurity attack
AMA President David Barbe says the government, technology and medical sectors need to take a more active roll to stop future cyberattacks to ensure the confidentially of healthcare data.
By David Lim • Dec. 12, 2017 -
FDA debuts new clinical support software draft guide, backs off certain regulations
The agency also issued a plan clarifying the regulation of certain digital health products such as mobile applications and finalized guidance on Software as a Medical Device.
By David Lim • Dec. 8, 2017 -
Hospitals facing IV solution shortages after Hurricane Maria
The FDA has granted one of the largest manufacturers of IV solutions permission to import IV bags from its facilities in other countries.
By David Lim • Nov. 16, 2017 -
New alliance aims to advance digital therapeutics
Founding members include Akili Interactive, Propeller Health, Voluntis and WellDoc.
By Meg Bryant • Oct. 27, 2017 -
FDA unveils digital health pilot program to speed up certification process
The agency also published its Digital Health Innovation Action Plan, which provides detail and timelines related to digital health and the 21st Century Cures Act.
By Jeff Byers • July 27, 2017 -
Anthem to pay record $115M to settle data breach lawsuit
The payer agreed to set aside funding for cybersecurity improvements, as well as cover two years of credit protection and $15 million worth of out-of-pocket costs for those affected.
By Shannon Muchmore • Updated Aug. 16, 2018
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