Concussion test gets breakthrough nod in fast-growing field

Brain Box's test diagnoses and rates the severity of traumatic brain injury, the incidence of which is on the rise.

By Susan Kelly • June 7, 2019

Executives expect AI to transform healthcare within 3 years

Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.

By Nick Paul Taylor • June 6, 2019

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

LabCorp says 7.7M patients exposed in same data breach as Quest Diagnostics

The company Wednesday also announced Adam Schechter, current lead independent director of LabCorp's board and longtime Merck executive, will replace David King as CEO Nov. 1.

By David Lim • June 5, 2019

House committee passes 6% increase in FDA funding

The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.

By Nick Paul Taylor • June 5, 2019

Beckman Coulter buys Cytobank to add data analysis software

The Danaher-owned company said the software will complement its flow cytometer and help manage more complex workflows.

By Nick Paul Taylor • June 5, 2019

Multi-cancer blood test shows early promise at ASCO

Grail, with backers including Amazon, Bill Gates, Alphabet venture arm GV, J&J and Celgene, said it would move forward with testing based on positive early data presented in a poster at the cancer meeting.

By Susan Kelly • June 3, 2019

11.9M Quest Diagnostics patients potentially exposed to data breach

Financial, medical and other personal information, such as Social Security numbers, may have been exposed, the company reported Monday morning.

By David Lim • June 3, 2019

Resolution lands FDA breakthrough nod for liquid biopsy

The company says Resolution HRD could be the first approved test of its kind capable of detecting gene deletions from cell-free DNA.

By Nick Paul Taylor • May 31, 2019

Qiagen launches companion test for Novartis breast cancer treatment

The diagnostic test aids in identifying HR+/HER2- breast cancer patients with a PIK3CA mutation who may benefit from treatment with Novartis' newly approved Piqray.

By Susan Kelly • May 29, 2019

Verily creates machine learning tool to aid diagnostic development

DeepMass expanded the coverage of known biomarkers when applied to clinical data.

By Nick Paul Taylor • May 29, 2019

Extragenital tests for chlamydia and gonorrhea get FDA nod

The products from Hologic and Cepheid are the first authorized to test samples from the throat and rectum, methods that could help more people get screened and treated faster.

By Susan Kelly • May 24, 2019

Test kit to speed diagnosis of joint replacement infections wins De Novo

FDA thinks the product from CD Diagnostics, acquired by Zimmer Biomet in 2016, will help doctors decide if patients need to undergo revision surgery.

By Maria Rachal • May 24, 2019

FDA authorizes Zika test, mulls revoking emergency clearances

The agency granted the first non-emergency marketing authorization for a Zika virus diagnostic to InBios.

By Nick Paul Taylor • May 24, 2019

Faulty platelet counts trigger Class I recall of Beckman Coulter devices

FDA is aware of more than 2,000 U.S. laboratories that may be affected by the inaccurate platelet counting but, so far, the agency hasn't received any reports of serious adverse events.

By Nick Paul Taylor • May 24, 2019

Medical equipment hit by escalation of US-China trade war

Between tariffs already enacted and an additional $300 billion in products on the table, imaging equipment, diagnostic reagents, surgical gloves and contact lenses stand to be among the medical devices affected.

By Nick Paul Taylor • May 15, 2019

Will a big needle burst the NASH bubble?

With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market. 

By Jacob Bell • May 14, 2019

Grail's multi-cancer blood test nabs breakthrough device status

The Bezos and Gates-backed cancer diagnostic developer said the FDA designation will expedite the early detection methylation technology it is testing. Exact Sciences, Guardant Health and others share goals in the space.

By Maria Rachal • Updated May 14, 2019

Same-day upper and lower endoscopies improve care, costs: JAMA

Johns Hopkins researchers used Medicare claims data to identify patterns suggesting overuse of different-day scheduling, especially when physician offices and freestanding ambulatory surgery centers did the scheduling.

By Susan Kelly • May 14, 2019

LabCorp to sell Qiagen companion diagnostic for bladder cancer

The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson’s newly approved therascreen fibroblast growth factor receptor kinase inhibitor Balversa.

By Susan Kelly • May 13, 2019

Eye scan to detect Alzheimer's biomarker gets breakthrough status

Optina Diagnostics' retinal imaging platform uses artificial intelligence to detect amyloid plaques in the brain and is intended to improve diagnostic accuracy as a non-invasive, low-cost tool.

By Susan Kelly • May 10, 2019

Myriad guidance disappoints investors as pricing pressures dampen expectations

The molecular diagnostic company expects full year EPS to fall well short of the previously forecast range and warned pricing pressures will affect performance in 2020.

By Nick Paul Taylor • May 9, 2019

FDA updates imaging rules in final guidance

The agency aims to align U.S. performance standards for X-ray imaging equipment with international policy, efforts supported by industry groups, and clarify aspects of U.S. requirements for fluoroscopic equipment.

By Susan Kelly • May 8, 2019

Verily's nanoparticle diagnostic program evolves into Verve partnership

Alphabet's life sciences research arm was initially interested in nanoparticle diagnostics but thinks the program has therapeutic potential.

By Nick Paul Taylor • May 8, 2019

ACLA, AdvaMedDx, BIO call for VALID Act movement by year-end

Despite differences between clinical labs and diagnostic manufacturers, industry wants to keep the legislation at the top of mind for Congress before the election and user fee negotiations suck oxygen away from the effort next year. 

By David Lim • May 7, 2019

Test for circulating tumor DNA wins FDA breakthrough designation

Genetic testing company Natera is developing the product to detect and quantify post-surgery ctDNA in the blood of patients already diagnosed with some types of cancer.

By Susan Kelly • May 7, 2019