Medical Devices: Page 178
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Medtronic gets expanded FDA label for cardiac pacing lead
The label expansion covers use of the device in His bundle pacing.
By Nick Paul Taylor • July 13, 2018 -
Medtech spared as US unveils tariffs on imports worth $200B
Most medical devices will not be affected by the proposed 10% levy.
By Nick Paul Taylor • July 13, 2018 -
Explore the Trendline➔
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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 -
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 -
EndoGastric Solutions raises $31M to commercialize reflux device
The device is designed to treat the root cause of gastroesophageal reflux disease.
By Nick Paul Taylor • 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 -
Stryker names new president, tweaks leadership structure
Timothy Scannell will take over effective next month. The 28-year company veteran had been group president for the MedSurg and Neurotechnology businesses for nearly a decade.
By Susan Kelly • July 11, 2018 -
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 -
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 -
Healthcare startups raise $15B across 779 deals in first half of year
June was a slow month, however, with investments down 3% from the prior year, according to a Pitchbook analysis for Forbes.
By Meg Bryant • 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 -
Boston Scientific buys atrial fibrillation device maker for $200M
The company has been an investor in Cryterion since 2016 and the deal gives it the roughly 65% remaining stake it does not already own.
By Susan Kelly • July 9, 2018 -
Mercy joins forces with Johnson & Johnson for medical device safety
The Food and Drug Administration is pressing medical device companies to include more real-world data in technology assessments.
By Meg Bryant • July 6, 2018 -
Amazon's medical supply chain ambitions: 4 things to know
“Online channel[s are] going to be the primary marketplace[s] for even the most premium of medical devices in the future,” Amazon's global healthcare leader Chris Holt told Healthcare Dive.
By Rebecca Pifer • July 6, 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 -
Digital health funding sets new H1 record with $3.4B across 193 deals
The sustained growth reflects the sector’s maturation along with a healthy venture ecosystem, a new Rock Health report says. However, despite bullish investment in digital health startup, exits have been slow.
By Meg Bryant • July 3, 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 -
Novartis to spin out Alcon into standalone device company
After months of weighing its options, the Swiss pharma is focusing in on therapeutics and shedding its ophthalmology device business.
By Lisa LaMotta • June 29, 2018 -
GE to spin off healthcare unit in latest restructuring
Moody's and investors applauded the move, which comes amid a reboot of the health division.
By Meg Bryant • June 27, 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 -
UPS seeks to disrupt implantable medical device supply chain
But without device manufacturer buy-in, uptake of the effort appears to be slow.
By David Lim • June 5, 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 -
Hospitals must improve medication adherence system use to protect patients, report says
Many hospitals are struggling to properly use technology designed to prevent bedside medication errors.
By David Lim • April 13, 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
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