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

FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis

The time it took for the FDA to reach 510(k) decisions decreased by 24 days, but the agency is still working through a pandemic-driven backlog of premarket approval applications.

By Nick Paul Taylor • July 24, 2023

Abbott Q2 net profit falls as weaker COVID test sales drag on revenue

Stronger medical device sales and a recovery in the infant formula business partly offset the impact of reduced COVID-19 testing.

By Susan Kelly • July 20, 2023

QuidelOrtho test could miss heart attacks, drawing Class I recall

The company advised clinicians to immediately discontinue using the test and switch to another method if possible.

By Elise Reuter • July 17, 2023

Illumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say

Canaccord Genuity analysts, commenting on a Financial Times article predicting a record EU fine against the DNA sequencer for closing its Grail acquisition, said it looks “almost certain” regulators will force a divestiture.

By Susan Kelly • July 6, 2023

Roche test for accelerating Alzheimer’s diagnosis granted FDA clearance

As treatments for early Alzheimer’s disease come to market, demand for techniques to accelerate diagnosis could increase.

By Nick Paul Taylor • June 30, 2023