FDA rescinds LDT final rule

Regulation of lab developed tests returns to its status before the agency attempted to expand its jurisdiction and industry groups sued to stop it.

By Susan Kelly • Sept. 19, 2025

House committee advances Medicare coverage bill for breakthrough devices

AdvaMed welcomed the committee’s work on the legislation but called for the inclusion of diagnostics in the bill.

By Nick Paul Taylor • Sept. 18, 2025

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

New bill would reform lab test payment rates

The bipartisan legislation, introduced this week in the House and Senate, seeks to prevent more cuts to Medicare reimbursement rates for diagnostic tests.

By Susan Kelly • Sept. 12, 2025

Medtech VC funding on track to hit highest value since 2021: PitchBook

“Larger rounds increasingly favor top-tier companies and AI-native startups, leaving other startups fighting for a smaller pool of capital,” the firm said.

By Nick Paul Taylor • Sept. 2, 2025

Quest forms joint venture with Corewell Health

The diagnostics company will open a lab with Corewell Health in 2027 and manage the not-for-profit health system’s existing lab facilities.

By Nick Paul Taylor • Aug. 27, 2025

Tempus inks $81M Paige buyout to support AI model development

CEO Eric Lefkofsky said that buying Paige “substantially accelerates” Tempus’ effort to build the largest foundation model in oncology.

By Nick Paul Taylor • Aug. 26, 2025

US to maintain lower tariff rates on China imports for 90 more days

China also extended its suspension of additional retaliatory duties against U.S. goods, maintaining current rates until November.

By Max Garland • Aug. 12, 2025

GE HealthCare projects reduced tariff expense

Executives also said demand for capital equipment continues to be healthy. However, investors may have expected stronger order growth.

By Susan Kelly • July 30, 2025

Quest, Labcorp downplay ‘Big Beautiful Bill’ impact

Executives at the laboratory companies said they expect the effects on testing services from the Republicans’ tax and domestic policy bill, including cuts to Medicaid, will be minimal.

By Susan Kelly • July 29, 2025

Labcorp to buy some Community Health assets for $195M

The deal includes outreach laboratory services in 13 states. Community Health will continue to operate its inpatient and emergency department labs along with other hospital-based testing services.

By Susan Kelly • July 24, 2025

Agilent CFO Bob McMahon resigns

Rodney Gonsalves, corporate controller and principal accounting officer, will take on interim CFO duties. Analysts said the company’s reaffirmed third-quarter guidance should reassure investors.

By Susan Kelly • July 17, 2025

Abbott lowers sales forecast on diagnostics decline, US funding cuts

Medical device sales remained a bright spot for the company, however, with more than 20% growth in diabetes devices.

By Elise Reuter • July 17, 2025

Quest to offer Fujirebio’s FDA-cleared Alzheimer’s blood test

The company plans to make the diagnostic available to physicians and researchers this summer, expanding its portfolio beyond laboratory developed tests.

By Nick Paul Taylor • July 15, 2025

Waters, BD biosciences unit agree to $17.5B merger

The BD business will be spun off and merged with a Waters subsidiary. Waters shares were down about 11% in early trading Monday on the news.

By Susan Kelly • July 14, 2025

Danaher appoints Martin Stumpe as chief technology and AI officer

The company said Stumpe’s promotion is a “pivotal step in [its] digital transformation and its ambition to lead the next era of innovation in life sciences and diagnostics.”

By Nick Paul Taylor • June 30, 2025

MedTech Europe urges EU to exclude devices, diagnostics from trade war

MedTech Europe said the EU’s list of products it could target in retaliation for U.S. actions “includes over 800 trade codes related to medical technologies.”

By Nick Paul Taylor • June 23, 2025

Illumina to buy SomaLogic for up to $425M

Illumina said adding SomaLogic would support the company’s multiomics strategy and strengthen the value of its NovaSeq X products.

By Susan Kelly • June 23, 2025

Could the FDA take an indirect approach to regulate LDTs?

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

By Susan Kelly • June 16, 2025

Quest partners with MD Anderson to develop cancer risk blood test

Quest plans to refine, develop and validate the technology and is aiming to launch the test in North America next year.

By Nick Paul Taylor • June 13, 2025

Caris Life Sciences plans $424M IPO

Caris, which offers tools for disease diagnosis, therapy selection and treatment monitoring, is the latest company to test the medtech IPO market.

By Susan Kelly • June 10, 2025

Freenome posts pivotal liquid biopsy data as FDA filing nears completion

Freenome plans to complete all modules of its premarket approval submission in mid-2025.

By Nick Paul Taylor • June 4, 2025

Clairity receives FDA OK for breast cancer risk prediction tool

The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict breast cancer risk over five years.

By Elise Reuter • June 3, 2025

FDA declines to appeal court order that stopped LDT final rule

“The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen analysts wrote.

By Susan Kelly • June 3, 2025

AstraZeneca drug could help keep a common breast cancer at bay

Data presented at ASCO show that swapping in the oral drug camizestrant for an older therapy helped sustain the benefit of initial treatment, potentially opening a novel step in patient care.

By Ned Pagliarulo • June 2, 2025

Teal posts data on newly approved at-home cancer screening device

Self-collection correctly identified 95.2% of HPV samples that are associated with increased cancer risk.

By Nick Paul Taylor • May 20, 2025