Device industry lobbies FDA on combo product classification

AdvaMed argues the agency too often concludes a product’s primary mode of action is that of a drug or biologic rather than a device.

By Susan Kelly • July 17, 2018

J&J says medical device sales improve in second quarter

CEO Alex Gorsky told investors on a conference call the company is "very interested in value creating inorganic growth opportunities in medical devices."

By Susan Kelly • July 17, 2018

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Medical 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

Cannabis-based drugs and devices: A winning combo?

Tetra Bio-Pharma and Storz & Bickel will collaborate to bring a marijuana-based drug, inhaled in an herbal vaporizer, to fibromyalgia patients in Canada.

By Barbara Boughton • July 17, 2018

Quest study contends value-based care adoption has slowed

The survey found that 57% of health plan executives believe physicians do not have the necessary tools to succeed in a value-based system, up from 45% last year.

By David Lim • July 17, 2018

Biogen looking to expand into medtech: report

The biotech is considering how imaging and data technologies could bolster its position in neurology, according to the Israeli paper Globes. 

By Lisa LaMotta • July 16, 2018

Abbott device to repair leaky heart valves approved

Artificial heart valve pioneer Edwards LifeSciences is developing treatments for mitral regurgitation that would compete with Abbott's MitraClip.

By Susan Kelly • July 16, 2018

CMS targets data gaps in setting lab payments

The American Clinical Laboratory Association said it "will urge Congress as well as CMS to address significant shortfalls in the data collection process that jeopardize care for the most vulnerable seniors."

By Susan Kelly • July 16, 2018

Transition clock ticking on new EU device regs

"It's a problem because how do you comply with a new standard when you don't know what the standard is?" said AdvaMed's Joe Gatewood.

By Meg Bryant • July 16, 2018

More insurers using outcomes-based deals with drug, device companies

Heart, infectious diseases and oncology are the top three therapeutic areas where the contracts are used, according to an Avalere survey.

By Meg Bryant • July 13, 2018

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

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