Four ways to win the future of MedTech wearables

As the market for MedTech wearables heats up, new and incumbent companies are eager to capitalize on the trends. But which ones will win? And why?

Sept. 20, 2021

Philip Morris takes control of Vectura amid pushback against acquisition

The tobacco giant has secured investor buy-in despite continued opposition from clinicians and reports that employees of inhaled medicine specialist Vectura are concerned about the change in ownership.

By Nick Paul Taylor • Sept. 17, 2021

Explore the Trendline➔

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

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

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

Delta patients clog hospitals, spur more procedure delays

Intermountain is the latest system to announce it's postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said Friday.

By Hailey Mensik • Sept. 15, 2021

Medtronic-Axonics neuromod IP fight sees another split patent board ruling

The dispute will drag on in the courts after PTAB's final ruling. Medtronic said it will ask a California court to lift its stay. 

By Nick Paul Taylor • Updated Sept. 23, 2021

Zimmer latest medtech to warn of delta wave drag in Q3

The company cautioned that delta variant pressures could extend into the fourth quarter. Despite the warning of the impact on the business, Zimmer's stock price was up nearly 5% Tuesday.

By Nick Paul Taylor • Sept. 15, 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

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

NuVasive warns of delta hit in Q3 as hospitals once again limit electives

The company's update offers another early indicator that medtechs will likely be hit in the third quarter due to delta variant surges.

By Nick Paul Taylor • 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

Jefferies lowers medtech outlooks as hospitals project delta pressure into Q4

The investment bank lowered its third quarter outlook for medical device companies with revenues heavily based on surgical volumes, including Boston Scientific, Medtronic and Stryker.

By Rebecca Pifer • 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

FDA ends summer with fresh batch of breakthrough device designations

Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

By Nick Paul Taylor • Sept. 10, 2021

ResMed touts CPAP survival benefits for sleep apnea after HHS doubts therapy efficacy

The ResMed-funded analysis of a French database comes on the heels of a government review finding the evidence does not back a link between continuous positive airway pressure therapy and clinically important outcomes.

By Greg Slabodkin • Sept. 9, 2021

Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 8, 2021

TransMedics wins FDA nod for donor heart preservation system

Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.

By Susan Kelly • Sept. 7, 2021

Bill Gates-backed Vicarious Surgical targets Intuitive, J&J, Medtronic in abdominal robotic surgery

The robotics startup, with investors including BD, wants to grow sales to $1 billion by 2027. CEO and co-founder Adam Sachs told MedTech Dive legacy robot platforms have fallen short in terms of cost and efficiency.    

By Greg Slabodkin • Sept. 7, 2021

ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

By Ricky Zipp • Sept. 3, 2021

Pandemic spurs rise of other infections contracted at healthcare facilities

The largest increase at hospitals from 2019 to 2020 was seen in bloodstream infections associated with central line catheters, according to the CDC.

By Hailey Mensik • Sept. 2, 2021

Baxter's $10.5B Hillrom buy on track, deal to close by early 2022: CEO

Baxter CEO Joe Almeida said the standard U.S. antitrust waiting period expired with no second FTC information request. Other global regulatory hurdles remain and shareholders are set to vote on the deal on Dec. 2.

By Greg Slabodkin • Updated Oct. 28, 2021

Smoking pot before knee, hip replacements linked with more complications

With marijuana use rising quickly in U.S. adults aged 45 to 64 years, three studies presented at the American Academy of Orthopaedic Surgeons meeting sought to find out if consumption affects outcomes.

By Nick Paul Taylor • Sept. 2, 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

Outpatient facilities targeted for cyberattacks nearly as often as hospitals, data shows

The number of breaches at healthcare organizations in the first half of this year was up significantly from the first half of last year, and higher than any six-month period since 2018, according to the Critical Insight report.

By Hailey Mensik • Aug. 30, 2021