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

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

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

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

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

MedTech Europe says MDR, IVDR framework needs ‘structural reform’

Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.

By Susan Kelly • Sept. 18, 2023

FDA finalizes breakthrough device changes to target health inequities

The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.

By Nick Paul Taylor • Sept. 18, 2023

Beacon Biosignals receives FDA clearance for sleep tracking headband

The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.

By Nick Paul Taylor • Sept. 18, 2023

Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA

The company contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode.

By Nick Paul Taylor • Sept. 14, 2023

FDA finalizes biocompatibility guidance for devices that touch the skin

The agency chose not to make some major requested revisions, such as including metals in the scope of the guidance.

By Nick Paul Taylor • Sept. 14, 2023

FDA finalizes combination product guidance 7 years after sharing draft

AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”

By Nick Paul Taylor • Sept. 13, 2023

TB deaths prompt FDA warning on reducing transmission risk

The agency outlined risk mitigation strategies for cell and tissue products after two recipients of bone matrix products died.

By Nick Paul Taylor • Sept. 13, 2023

CMS digs deeper into impact of proposed breakthrough device pathway in JAMA paper

The article discusses what the TCET pathway will mean for products at different stages of the life cycle.

By Nick Paul Taylor • Sept. 12, 2023