Diagnostics

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.

Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.