Friend, not foe: How AI will revolutionize patient care

Artificial intelligence should be embraced to help streamline data and tackle clinician burnout, says Medtronic’s Stacey Churchwell.

By Stacey Churchwell • Oct. 2, 2023

FDA to regulate lab-developed tests under proposed rule

The tests have come under scrutiny by the agency and lawmakers, but the FDA is still likely to face pushback on the changes.

By Elise Reuter • Sept. 29, 2023

Explore the Trendline➔

The MedTech Dive Outlook on 2021

The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.

By MedTech Dive staff

Abbott data suggests GLP-1 drugs a ‘modest accelerator’ for CGMs: analysts

The analysis of U.S. insurance claims found people on GLP-1 therapy wear their FreeStyle Libre sensors more.

By Nick Paul Taylor • Sept. 29, 2023

As government shutdown looms, medical device reviews expected to continue

The FDA could furlough nearly a fifth of its staff by Sunday if Congress doesn’t reach a funding agreement. 

By Elise Reuter • Sept. 28, 2023

Galen robot gets FDA de novo clearance for ENT surgeries

The startup affiliated with Johns Hopkins University said it is opening a bridge round for its series B financing as it targets more applications for the robotic surgery assistant.

By Susan Kelly • Sept. 28, 2023

Artificial heart maker’s cash runway shrinks to 1 month after supply woes hurt sales

France’s Carmat expects revenues of up to 6 million euros in the second half of the year but needs to secure financing to avoid running out of money.

By Nick Paul Taylor • Sept. 28, 2023

Harbinger Health raises $140M to study blood-based cancer screening test

The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.

By Nick Paul Taylor • Sept. 28, 2023

Siemens Healthineers buys Aspekt to bolster radiation oncology services

The company’s Varian unit sees Aspekt as complementary to its Advanced Oncology Solutions business, which provides professional and clinical services.

By Nick Paul Taylor • Sept. 27, 2023

FDA finalizes guidance on cybersecurity for medical devices

Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October. 

By Nick Paul Taylor • Sept. 27, 2023

Device component-maker Zeus exploring sale: Reuters

The firm, which manufacturers catheters and other medical components, could be valued at $4 billion or more, according to the report.

By Elise Reuter • Sept. 26, 2023

Edwards Lifesciences says it was target of surprise EU antitrust inspection

The European Commission announced the action last week without naming the cardiovascular device company.

By Susan Kelly • Sept. 26, 2023

Surgical robot maker Vicarious faces possible NYSE delisting

The company’s shares could be delisted from the New York Stock Exchange if the price does not rise above $1.

By Elise Reuter • Sept. 26, 2023

Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts

It is not yet clear how different approaches would benefit specific patients, creating uncertainty about which businesses will profit from the shift.

By Nick Paul Taylor • Sept. 26, 2023

Enovis inks $847M acquisition to boost orthopedic reconstruction business

A Wells Fargo analyst said the deal was “much larger than what we were expecting.”

By Nick Paul Taylor • Sept. 26, 2023

Intarcia’s diabetes drug-device combo voted down again by FDA panel

The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.

By Gwendolyn Wu • Sept. 25, 2023

Developer of miniaturized surgical robot extends funding round

Virtual Incision, whose surgical robot is headed to the International Space Station next year, raised $30 million in an extension of its series C round.

By Susan Kelly • Sept. 25, 2023

Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom

Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom. 

By Nick Paul Taylor • Sept. 25, 2023

FDA shares draft medical device harmonization plan to meet MDUFA V goal

The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.

By Nick Paul Taylor • Sept. 25, 2023

How can medical device OEMs support the circular economy?

Discover how medical device OEMs can be part of the circular economy for a more sustainable future.

Sept. 25, 2023

Hologic allies with Bayer to support uptake of contrast-enhanced mammography

The companies will provide a product package and training intended to support adoption of the imaging technique.

By Nick Paul Taylor • Sept. 22, 2023

Is bigger better? McKinsey predicts the return of large medtech mergers

The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.

By Nick Paul Taylor • Sept. 22, 2023

Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026

Management predicts PFA’s share of the AFib ablation market will climb from less than 5% now to as much as 80% in five years.

By Nick Paul Taylor • Sept. 22, 2023

Hamilton Medical recalls ventilators for control board problem

The issue can cause a short circuit or lead the capacitor to lose function, interrupting ventilation.

By Elise Reuter • Sept. 21, 2023

CMR Surgical secures $165M for its robot expansion

The new funding will also support product innovation efforts as the company builds a position in the fast-growing robotic surgery market.

By Susan Kelly • Updated Sept. 21, 2023

Limited resources constrain federal oversight of medical device ads, GAO finds

U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.

By Nick Paul Taylor • Sept. 21, 2023