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

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

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 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

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

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

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

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

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

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

GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.

By Nick Paul Taylor • Sept. 15, 2023

Study suggests AI could provide second reading of mammograms

In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”

By Elise Reuter • Sept. 12, 2023

Walgreens to pay $44M to settle claims over fraudulent Theranos tests

If a judge approves the settlement, patients who bought a Theranos blood test would receive double the amount they paid for it. 

By Elise Reuter • Sept. 8, 2023

Microsoft, Paige team to use supercomputers to train cancer pathology AI models

Microsoft will support development of a new model that is “orders-of-magnitude larger” than any in use today.

By Nick Paul Taylor • Sept. 8, 2023

FDA proposes 3 guidances to improve 510(k) clearance process

The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

By Nick Paul Taylor • Sept. 7, 2023

Cue Health board pressured by investor to review strategy, cut costs

Tarsadia Investments called for the board to “take immediate action to prevent further destruction of stockholder value.”

By Nick Paul Taylor • Sept. 6, 2023

Guardant abandons cancer blood test trial early, restates confidence in product line

Guardant stopped enrolling new patients in the study because of its design and use of an older generation test, analysts said.

By Nick Paul Taylor • Sept. 6, 2023

Illumina names Agilent’s Jacob Thaysen as its next CEO

The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.

By Susan Kelly • Sept. 5, 2023

23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants

The new version of the test can report more cancer-related gene mutations, and 23andMe can add variants in the future under an agreement with the FDA. 

By Nick Paul Taylor • Sept. 5, 2023

Noah Medical lung biopsy robot exceeds expectations in first-in-human trial

The startup presented early data on its FDA-cleared system at a meeting of pulmonologists in Chicago.

By Susan Kelly • Sept. 1, 2023

UK regulators name 3 approved bodies to ease device certification bottleneck

A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”

By Nick Paul Taylor • Aug. 31, 2023

Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

The groups want changes that include expanding the program to cover breakthrough diagnostics and previously authorized products.

By Nick Paul Taylor • Aug. 30, 2023

VC funding in medtech ticks up, raising hopes that slump has bottomed

Analysts also forecast renewed interest in M&A now that large companies have worked through a string of spinoffs.

By Nick Paul Taylor • Aug. 25, 2023