Digital Health

GE Healthcare to buy BK Medical for $1.45B

The deal is aimed at expansion beyond diagnostics into surgical and therapeutic interventions, with high-single-digit return on invested capital anticipated by year five, CEO Kieran Murphy said.

By Greg Slabodkin • Sept. 23, 2021

Paige's AI-based software gets FDA nod to help doctors identify prostate cancer

It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.

By Nick Paul Taylor • Sept. 22, 2021

FTC warns app makers fall under breach notification rule

The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

By Shannon Muchmore • Sept. 16, 2021

Q&A

Hillrom VP of connected care talks Baxter's $10.5B buy, digital health

The deal, medtech's largest of 2021, is driven by Hillrom's digital health presence. Trey Lauderdale, Hillrom vice president and general manager of care communications, says the Baxter acquisition is validation of their strategy.

By Greg Slabodkin • Sept. 16, 2021

CMS moves to scrap MCIT rule due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

By Nick Paul Taylor • Sept. 14, 2021

Deep Dive

Medtechs are boosting DTC investment, but industry still years behind pharma

Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

By Ricky Zipp • Sept. 14, 2021

MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

By Nick Paul Taylor • Sept. 13, 2021

iRhythm announces new CEO, the second since December, amid tumultuous 2021

Quentin Blackford, who is leaving the position of chief operating officer for Dexcom, will officially take over the role on Oct. 4. iRhythm's stock price shot up by over 34% Monday morning following the announcement.

By Ricky Zipp • Sept. 13, 2021

Sponsored by ZS

How to transform medtech customer engagement

Omnichannel opens new paths for medtech customer engagement success. 

By Will Randall • Sept. 13, 2021

Baxter to buy Hillrom for $10.5B in bid to expand connected care portfolio

Wall Street analysts and investors had previously questioned the price and strategic fit of a deal, which was rumored for weeks.

By Greg Slabodkin • Sept. 02, 2021

Zimmer 'smart knee' gets FDA nod as ortho rivalry with Stryker heats up

The orthopaedics device maker, through a collaboration with Canary Medical, becomes the first company to bring an implantable smart device for total knee replacement to the U.S. market.

By Susan Kelly • Aug. 31, 2021

Baxter in late-stage talks to buy Hillrom for about $10B: WSJ

A Baird analyst said he talked himself into backing a union given Hillrom's connected care push. However, J.P. Morgan analysts argued Baxter has a "tall order" convincing investors it's a "more strategic vs. financial" acquisition.

By Greg Slabodkin • Aug. 30, 2021

Mayo Clinic, Alphabet's Verily partner to build clinical decision support tools

The two plan to initially focus on a set of cardiovascular and cardiometabolic conditions.

By Rebecca Pifer • Aug. 27, 2021

Google disbands health unit as chief departs for Cerner

The dissolution of the division is the latest rolled back initiative from a tech giant in the space.

By Rebecca Pifer • Aug. 25, 2021

Sponsored by Avail

Remote collaboration from the operating room: The 'new normal' for medtech

For too long, medical information sharing and collaboration has depended on in-person communication. The COVID-19 pandemic has caused us to rethink how we deliver healthcare.

By Jerry Carter, Avail Medsystems • Aug. 23, 2021

Sponsored by GE Healthcare

Post call: How a pandemic transformed healthcare for the future

From the frontlines of 2020 to the forefront of the future, what worked, what didn’t, and what must be prioritized today to thrive tomorrow. 

Abiomed leads latest FDA breakthrough designations for heart disease devices

The agency awarded the breakthrough privileges to Abiomed's Impella ECP, which the company contends is the world's smallest heart pump and could provide critical hemodynamic support to coronary artery disease patients.

By Nick Paul Taylor • Aug. 19, 2021

Deep Dive

Predicting the future of healthcare: 10 takeaways from HIMSS21

Along with "guarded optimism" on the current state of the pandemic, some 19,000 on-site attendees in Las Vegas mulled what's next for AI, telehealth, cybersecurity, mental health and more.

By Rebecca Pifer , Hailey Mensik • Aug. 17, 2021

Q&A

Q&A with Philips' head of connected healthcare on new products, hospital tech adoption in the COVID-19 era

Roy Jakobs caught up with Healthcare Dive virtually on the sidelines of HIMSS21 to chat about provider burden, interoperability and new products.

By Rebecca Pifer • Aug. 12, 2021

Opinion

Digital therapeutics — a double-edged sword?

Aloha McBride, EY's global health leader, argues that algorithms need to be regularly audited and screened for bias and discrepancies, while clinicians play a vital role in explaining the key features of apps and patient privacy risks.

By Aloha McBride • Aug. 10, 2021

Deep Dive

Diabetes tech companies set sights on Type 2 patients as user numbers climb

With patients flocking to CGMs and insulin pumps over the past several years, companies like Dexcom, Insulet and Tandem are looking to further expand. 

By Ricky Zipp • Aug. 09, 2021

5 must-watch panels at an unprecedented HIMSS21

Masks and proof of vaccination will be required on the ground in Las Vegas, and a corresponding digital event will also take place.

By Rebecca Pifer • Aug. 09, 2021

iRhythm doesn't expect 2022 CMS pricing. 'It may take some time.'

Amid a challenging 2021, the cardiac monitoring player beat Wall Street revenue expectations. However, Medicare pricing uncertainty is still hanging over its future.

By Ricky Zipp • Aug. 06, 2021

Digital health, heart disease devices feature in latest FDA breakthrough designations

Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.

By Nick Paul Taylor • Aug. 02, 2021

Hillrom reverses course, will finalize $375M BardyDx acquisition

The decision ends a months-long fight by Hillrom to back out of the buy due to substantially reduced Medicare rate cuts for long-term cardiac monitoring. Hillrom expects the deal to close in the coming weeks.

By Ricky Zipp • Aug. 02, 2021