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

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

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

BARDA backs Satio’s work on patch-based Ebola test for use in remote settings

Satio will combine its patch-based blood collection device with Institut Pasteur de Dakar's Ebola virus immunoassay.

By Nick Paul Taylor • Aug. 23, 2023

Harnessing molecular diagnostics to address antibiotic shortages

Diagnostic testing can play an important role in public health by stopping the dangerous squandering of effective medicines that are in short supply, says David Persing, chief medical and scientific officer at Cepheid.

By David Persing • Aug. 22, 2023

Agilent to wind down Resolution Bioscience liquid biopsy unit

The company will discontinue operations at the business it bought two years ago for $550 million.

By Susan Kelly • Aug. 21, 2023

Google expands AI mammography deal with iCAD

The amendment extends the original licensing agreement to 20 years and could allow the AI system to serve as a second reader.

By Emily Olsen • Aug. 18, 2023

23andMe rival warns consumer test approach misses 90% of cancer variants

The retrospective study looked at the proportion of mutations in BRCA1/2 that are covered by 23andMe’s consumer genetic test.

By Nick Paul Taylor • Aug. 17, 2023

Labcorp scoops up Tufts Medicine outreach lab, continuing buying spree

As the laboratory services giant continues its acquisition streak, hundreds of employees will be let go at the Boston-based academic health system.

By Susan Kelly • Aug. 15, 2023

Illumina faces SEC probe over Grail acquisition

The securities regulator has asked for documents tied to the 2021 deal in addition to the conduct and compensation of members of Illumina and Grail management.

By Susan Kelly • Aug. 14, 2023

Cue Health wins $28M BARDA contract to develop rapid respiratory infection test

The company plans to launch the respiratory panel for the 2024-25 virus season and aims to break even in 2025.

By Nick Paul Taylor • Aug. 14, 2023

Median lag between FDA authorization and Medicare coverage hits 6 years: study

Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.

By Nick Paul Taylor • Aug. 11, 2023

Illumina shakes up executive team, lowers 2023 outlook

The gene sequencing industry leader, which is operating under an interim CEO, named a new chief technology officer and announced the departure of its chief medical officer.

By Susan Kelly • Aug. 10, 2023

Guardant, Illumina agree to end litigation, extend commercial partnership

The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.

By Susan Kelly • Aug. 8, 2023

Pressure mounts for Illumina to divest Grail amid record fine, executive changes

Illumina is facing a 432 million euro fine from European regulators and is looking for a new CEO.

By Elise Reuter • Aug. 8, 2023

Abbott lands FDA clearance of Alinity complete blood count system

The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.

By Nick Paul Taylor • Aug. 8, 2023

AI reduces radiologist workload in mammography clinical trial but expert urges caution

The trial linked the AI-supported screen-reading procedure, ScreenPoint Medical’s Transpara, to a 44% reduction in radiologist workload.

By Nick Paul Taylor • Aug. 2, 2023

Varian logistics slow growth at Siemens Healthineers in Q3

Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites. 

By Nick Paul Taylor • Aug. 2, 2023

Quest launches consumer test to assess Alzheimer’s risk

 As new drugs intended to slow cognitive decline reach the market, test makers see an opportunity for earlier detection of Alzheimer’s disease.

By Elise Reuter • July 31, 2023

Demand for 4-in-1 test helps Danaher’s COVID sales beat internal forecast

Danaher said it is continuing to take market share as many customers look to consolidate their point-of-care PCR testing platforms.

By Nick Paul Taylor • July 26, 2023