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

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

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

Stryker adds minimally invasive bunion device to fast-growing extremities portfolio

The company is making the case that the system reduces recurrence, scar size and opioid use.

By Nick Paul Taylor • Sept. 21, 2023

EU antitrust officials make surprise inspections at cardiovascular device company

The unnamed company may have violated EU rules against abusing a dominant market position, the European Commission said.

By Susan Kelly • Sept. 20, 2023

CMS leader defends breakthrough device reimbursement proposal at House hearing

Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.

By Nick Paul Taylor • Sept. 20, 2023

FDA makes device conformity testing scheme permanent to streamline assessments

The FDA has delivered on a MDUFA V commitment by turning ASCA into a permanent, voluntary accreditation program. 

By Nick Paul Taylor • Sept. 20, 2023

Gates Foundation grants GE HealthCare $44M for AI ultrasound tech

The money will go to subsidiary Caption Health to make AI tools to help with maternal care and pediatric lung health.

By Elise Reuter • Sept. 19, 2023

Boston Scientific to buy back pain treatment company Relievant for $850M

The company, which makes a treatment for chronic back pain, is expected to bring in more than $70 million in sales this year.

By Elise Reuter • Sept. 19, 2023

J&J starts trial of pulsed field ablation catheter with mapping feedback

Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data.

By Nick Paul Taylor • Sept. 19, 2023

FDA releases draft guidance for studying weight loss devices

The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.

By Nick Paul Taylor • Sept. 19, 2023