FDA: ‘We have had a very loud voice’ on EtO

The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.

By Elise Reuter • Oct. 16, 2023

Masimo wins de novo authorization for measure of high blood oxygen levels

The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.

By Nick Paul Taylor • Oct. 16, 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

J&J receives 510(k) clearance for foot fixation device, targets growing bunion market

The clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.

By Nick Paul Taylor • Oct. 16, 2023

Illumina details EC timeline, funding requirements for Grail divestment

The European Commission ordered the gene sequencing company to support Grail with two-and-a-half years of funding if it pursues a spinoff.

By Susan Kelly • Oct. 13, 2023

FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.

By Nick Paul Taylor • Oct. 13, 2023

European Commission orders Illumina to divest Grail

The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.

By Susan Kelly • Oct. 12, 2023

Boston Scientific wins diabetic neuropathy approval, joining rivals in growing market

The expanded indication positions Boston Scientific to challenge Abbott, Medtronic and Nevro for the emerging opportunity in spinal cord stimulation to treat the condition.

By Nick Paul Taylor • Oct. 12, 2023

FDA to establish digital health advisory committee

The agency is seeking advisers to help it understand the benefits, risks and outcomes associated with digital technologies.

By Elise Reuter • Oct. 12, 2023

J&J’s Abiomed hit with FDA warning letter over Impella heart pump

The letter identifies quality system problems in a group of recalled devices and says monitoring software used with the pump requires premarket authorization.

By Susan Kelly • Oct. 12, 2023

AdvaMed elevates digital health center to division, names board

The new division will focus on four core policy priorities under Chair Taha Kass-Hout, chief technology officer at GE HealthCare.

By Susan Kelly • Oct. 10, 2023

J&J-backed HistoSonics gets de novo clearance for liver cancer treatment

The system offers a minimally invasive alternative to surgical resection and thermal ablation in patients with primary and metastatic liver cancers.

By Nick Paul Taylor • Oct. 10, 2023

EU poised to mandate Illumina sell Grail liquid biopsy unit: FT

Regulators could order the divestment of the business as soon as next week to punish Illumina for defying their authority and “illegally” acquiring Grail.

By Nick Paul Taylor • Oct. 10, 2023

Invitae test for hereditary cancers gains FDA de novo nod

The test analyzes DNA from a single blood sample to identify hundreds of variants in 47 genes associated with predispositions for a range of cancer types. 

By Susan Kelly • Oct. 3, 2023

FDA expands total product life cycle program to cover neurological devices

The agency could enroll up to 45 additional devices over the coming year.

By Nick Paul Taylor • Oct. 3, 2023

FDA details switch to electronic filings for 510(k), de novo submissions

The guidance documents advance the transition to eSTAR, an electronic template the FDA is adopting to meet legislative requirements.

By Nick Paul Taylor • Oct. 3, 2023

Mayo Clinic partner earns 510(k) clearance for heart failure screening algorithm

The algorithm analyzes 12-lead ECGs to show if a patient may be developing heart failure.

By Nick Paul Taylor • 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

FDA posts guidance on how to simplify updates to antimicrobial resistance tests

The advice focuses on predetermined change control plans, a mechanism the regulator sees as a way to streamline updates in multiple areas.

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

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

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

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

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

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