IVD

Pharmacy technician collecting a fingertip blood sample from a patient using Babson's BetterWay service.

MD+DI Readers Throw Support Behind Babson's BetterWay Blood Testing MD+DI Readers Throw Support Behind Babson's BetterWay Blood Testing

MD+DI readers voted for Babson Diagnostics as the 2024 Medtech Company of the Year.

byAmanda Pedersen

Dec 4, 2024

|

1 Min Read

Pharmacy tech using Babson's BetterWay technology to collect s pea-sized amount of blood from a patient's finger for blood testing.

The Year Babson Showed Us a 'BetterWay' to Do Blood Testing The Year Babson Showed Us a 'BetterWay' to Do Blood Testing

byAmanda Pedersen

Dec 3, 2024

1 Min Read

Guardant Wins False Advertising Lawsuit Against Natera Guardant Wins False Advertising Lawsuit Against Natera

Nov 26, 2024

1 Min Read

President-Elect Donald Trump and laboratory-developed tests

Regulatory & Quality

Trump’s Second Term Could Turn LDT Regulation on its Head Trump’s Second Term Could Turn LDT Regulation on its Head

byKatie Hobbins

Nov 15, 2024

1 Min Read

Influenza virus

Varro Receives $20M for Development of Novel Pathogen Detection Tech Varro Receives $20M for Development of Novel Pathogen Detection Tech

byKatie Hobbins

Nov 5, 2024

1 Min Read

Abbott Laboratories

Abbott Lifts Annual Profit Forecast, Banks on CGM Sales Abbott Lifts Annual Profit Forecast, Banks on CGM Sales

byKatie Hobbins

Oct 17, 2024

1 Min Read

Roche Secures CE Mark for New Companion Diagnostic

Roche Secures CE Mark for New CDx

Two women in a healthcare setting discuss FDA approval of self-collected vaginal specimens for testing using BDE Onclarity HPV

New Cervical Cancer Screening Tests Rival the Pap Smear

New Cervical Cancer Screening Tests Rival the Pap Smear

byKassandra Kania, Freelance Writer

A Shocking Turn in the Illumina/Grail Merger

A Shocking Turn in the Illumina/Grail Merger

Sponsored Content

How to Verify and Track Critical IVD Consumable Fluids.

How to Verify and Track Critical IVD Consumable Fluids

close up of a laboratory technician selecting and transferring embryos for in vitro fertilization (IVF)

This Test Represented a Turning Point in IVF History

This Test Represented a Turning Point in IVF History

byAmanda Pedersen

FDA Greenlights At-Home Syphilis Test

FDA Greenlights At-Home Syphilis Test

Grail Galleri

Grail Enacts Restructuring Plan, Cuts 350 Employees

Grail Enacts Restructuring Plan, Cuts 350 Employees

byKatie Hobbins, Managing Editor

Brain

New Blood Test Tech Could Change How We Treat Alzheimer's Disease

New Blood Test Tech Could Change How We Treat Alzheimer's Disease

byKatie Hobbins, Managing Editor

BD & Quest in Collaboration to Develop Companion Diagnostics

BD & Quest in Collaboration to Develop Companion Diagnostics

In Vitro Diagnostics

IVD Companies Face Layoffs

IVD Companies Face Layoffs

byKatie Hobbins, Managing Editor

Talia Grace Haller

Artificial Intelligence

Advancements in Digital Biomarkers & Medical Diagnostics

Advancements in Digital Biomarkers & Medical Diagnostics

Medtech in a Minute: BD Faces Product Shortage, and More

Medtech in a Minute: BD Faces Product Shortage, and More

byAmanda Pedersen

Photograph of a woman getting her finger-stick blood sample collected at a pharmacy by a pharmacy tech, with Babson Diagnostics' BetterWay service.

Siemens Blood Testing Spinoff Finds a 'BetterWay' to Succeed Where Theranos Failed

Babson Is Ready to Succeed Where Theranos Failed

byAmanda Pedersen

LDTs

Assessing Industry Impact of FDA’s LDT Final Rule

Assessing Industry Impact of FDA’s LDT Final Rule

Melanoma

Dermtech Files Chapter 11 Bankruptcy, Cuts 15 Employees

Dermtech Files Chapter 11 Bankruptcy, Cuts 15 Employees

byKatie Hobbins, Managing Editor

Vaccines

EU & Member States Contribute Over $800M to African Vaccines Manufacturing Accelerator

EU & Member States Contribute Over $800M to African Vaccines Manufacturing Accelerator

byKatie Hobbins, Managing Editor

LDT overview

ACLA Sues FDA to Block New LDT Oversight

ACLA Sues FDA to Block New LDT Oversight

byKatie Hobbins, Managing Editor

Cue Health

Cue the End Credits for This COVID-19 Test Maker

Cue the End Credits for This COVID-19 Test Maker

byKatie Hobbins, Managing Editor

Cue Health Pauses Sales of COVID-19 Tests After FDA Warning Letter

FDA Issues Warning Letter for Cue Health’s COVID-19 Test

5 Things You Need to Know About FDA’s Final Rule on LDTs

5 Things You Need to Know About FDA’s Final Rule on LDTs

Cue Health

Cue Health Axes 49% of Staff

Cue Health Axes 49% of Staff

byKatie Hobbins, Managing Editor

Vitek AST Kit

Regulatory & Quality

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

byKatie Hobbins, Managing Editor

Artificial Intelligence

Quest Finds its Path to AI in Cancer Diagnostics Through M&A

Quest Diagnostics in Plan to Acquire PathAI’s Assets

IVD

LDT Oversight Gets Long-Awaited FDA Final Rule

LDT Oversight Gets Long-Awaited FDA Final Rule

byKatie Hobbins, Managing Editor

Labcorp On the Verge of Acquiring Invitae’s Assets

Labcorp Set to Acquire Invitae's Assets for $239M

layoffs

DermTech Cuts 100, Seeks Strategic Alternatives

DermTech Cuts 100, Seeks Strategic Alternatives

byKatie Hobbins, Managing Editor

ReadyGo Sampler device

Porex Partners With UK-based Diagnostics Startup

Porex Partners With UK-based Diagnostics Startup

byNorbert Sparrow

Roche Lands Breakthrough Designation for Alzheimer’s Test

Roche Developing a Blood Test for Alzheimer's Disease

EU Regulators Approve Illumina’s Plan to Divest Grail

EU Regulators Approve Illumina’s Plan to Divest Grail

Sign up for the QMED & MD+DI Daily newsletter.