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

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New 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, 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

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

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

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

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

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