Hologic acquires developer of breast cancer surgery marker

The company agreed to pay $125 million for Focal Therapeutics, the latest addition to its breast health product portfolio, two months after purchasing digital imaging systems maker Faxitron Bioptics in an $85 million deal.

By Susan Kelly • Sept. 28, 2018

New IMDRF committee to tackle cybersecurity threats

The FDA device chief laid out takeaways from the group's Beijing meeting.

By Kim Dixon • Sept. 27, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Shuren: Funds needed to launch FDA Center of Excellence for Digital Health

The device center head's warning comes as Commissioner Scott Gottlieb stresses the importance that Congress keep investing in the FDA.

By David Lim • Sept. 27, 2018

FDA's Patel touts promise of software precertification program

Despite concern from the Clinical Decision Support Coalition​ that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.

By David Lim • Sept. 26, 2018

EY warns stagnant R&D, data use threatens medtech growth

Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.

By David Lim • Sept. 24, 2018

AI can identify lung cancer types in images, study finds

The program determined with 97% accuracy which images showed adenocarcinoma and those showing squamous cell carcinoma.

By Susan Kelly • Sept. 18, 2018

Welltok acquires text-based messaging platform Wellpass

Wellpass customers include Medicaid managed care and other government programs.

By Meg Bryant • Sept. 14, 2018

Epic, Nuance partner on voice assistance technology aimed at busy docs

The system is compatible with Epic's Rover and Haiku workflow apps and will allow physicians to get schedules, look up patient information and check lab results and medication lists.

By Meg Bryant • Sept. 13, 2018

New Apple Watch adds FDA-cleared ECG application

Agency officials touted the clearance as heralding a new age of digital health. Still, risks include false positives and negatives, which could lead to unneeded procedures or misdiagnosis.

By David Lim • Sept. 12, 2018

A call to make EHRs safer for pediatric patients

A viewpoint published in JAMA Pediatrics argues for a rigorous certification program for electronic health records used in pediatric care to prevent harm to young patients.

By Susan Kelly • Sept. 11, 2018

AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test

The agency has granted the designation, which fast tracks review, to 83 devices as of the end of July.

By David Lim • Sept. 11, 2018

Livongo adds continuous glucose data via Abbott's FreeStyle Libre

Gathering continuous glucose data is intended to help diabetes patients and their doctors personalize treatment and improve decisions about care.

By Susan Kelly • Sept. 7, 2018

Life science CEOs see future in technology, disruption

A KPMG survey also showed that cybersecurity remains a major pain point, with 33% of executives calling it the top risk to their organization's growth.

By Meg Bryant • Sept. 6, 2018

Deloitte joins with Vineti on cloud-based precision medicine platform

The effort combines Deloitte's analytics technology with the venture between Mayo and GE's cellular therapies software.

Sept. 5, 2018

Cigna names chief data and analytics officer

The appointment comes as the insurer attempts to swallow pharmacy benefits manager Express Scripts.

By Susan Kelly • Sept. 5, 2018

Otsuka rolls out Abilify digital pill through Magellan network

The digital pill will cost $1,650 for a 30-day supply, which includes the wearable sensor and MyCite app, according to the company.

By Susan Kelly • Sept. 4, 2018

Philips licenses Air Force mobile patient monitoring technology

The Andover, Massachusetts-based medtech giant plans to leverage the wearable system for telemedicine purposes.

By Meg Bryant • Aug. 31, 2018

Blockchain in healthcare: Huge promise, but largely unproven

"What blockchain has been able to do is create markets where a market didn't previously exist," according to Noah Zimmerman, director of Mount Sinai's Center for Biomedical Blockchain Research.

By Meg Bryant • Aug. 30, 2018

Gottlieb hails early breakthrough device successes, plans AI benchmarks

The commissioner set out how the FDA is accelerating the development of medical devices.

By Nick Paul Taylor • Aug. 30, 2018

Report offers framework for assessing EHR usability, safety

The voluntary roadmap includes criteria examples for developers and providers to use in testing EHR products at each lifecycle stage.

By Meg Bryant • Aug. 29, 2018

90% of Americans use digital health tools, survey shows

While 77% of consumers prefer in-person doctor visits over telehealth, most who choose video consults enjoy them, according to the Rock Health report.

By Meg Bryant • Aug. 29, 2018

Humana announces new center for digital health, analytics

One focus of Humana Studio H in Boston will be developing new health experiences for seniors.

By Meg Bryant • Aug. 28, 2018

Medication reminder apps for heart patients could save lives, study says

The American Heart Association says an estimated three out of four Americans do not take their medication as directed.

By Susan Kelly • Aug. 28, 2018

Dthera gets FDA breakthrough device status for Alzheimer's digital therapeutic

The device delivers reminiscence therapy to counter anxiety and depression.

By Nick Paul Taylor • Aug. 24, 2018

Merck relaunches diabetes management app as map4health

The app enables users to track their behavior and connect to healthcare professionals. Whether these new features will attract users remains to be seen in a crowded space.

By Nick Paul Taylor • Aug. 22, 2018