Diagnostics

Whoop secures $575M, with Abbott a strategic investor

Tue, 31 Mar 2026 12:00:00 -0400

Whoop Inc. secured $575 million in a series G funding round at a $10.1 billion valuation to advance its AI-powered wearable platform for personalized and preventive health care. Abbott Laboratories joined the round as a strategic investor, backing the company’s push to expand access to its device amid growing demand.

Supreme Court shuts the door to three life sciences petitions

Tue, 31 Mar 2026 11:00:00 -0400

What do a patent dispute over a CRISPR/Cas system, a rejected whistleblower case involving lab tests and a vaccine injury claim parading as multidistrict tort litigation have in common? All three were denied cert in the U.S. Supreme Court’s latest orders list.

University of Texas prepares RIPK1 PET imaging agents

Mon, 30 Mar 2026 09:00:00 -0400

A University of Texas System patent describes new radiolabeled positron emission tomography (PET) imaging agents targeting receptor-interacting serine/threonine-protein kinase 1 (RIPK1; RIP-1). As such, they are potentially useful for the diagnosis of cancer, retinal and autoimmune diseases, neurological and inflammatory disorders.

FDA reclassifies skin lesion diagnostic devices

Wed, 25 Mar 2026 12:00:00 -0400

The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Tue, 24 Mar 2026 12:00:00 -0400

AI and advanced biotechnology are reshaping South Korea’s med-tech sector, but great technology alone is not enough to build a successful medical device company, speakers said at MedTech Innovator’s Medtech Spotlight: New Impact Korea 2026.

How to grow a startup in the AI era: MedTech Spotlight Korea 2026

Mon, 23 Mar 2026 12:00:00 -0400

Roche secures CE mark for blood test to identify ApoE4 carriers

Tue, 17 Mar 2026 12:00:00 -0400

Roche Holding AG received CE Mark approval for its Elecsys Apolipoprotein E4 (ApoE4) biomarker test, an in vitro diagnostic immunoassay to identify the ApoE4 gene variant from a blood sample. With APOE4 considered as the strongest genetic risk factor for developing Alzheimer’s disease, the test provides a fast, reliable way to determine whether an individual carries the genetic variant without the need for DNA‑based genotyping.

Precision psychiatry beyond, or before, biomarkers

Fri, 13 Mar 2026 09:00:00 -0400

There is broad agreement that psychiatric diagnoses in their current form are not reflective of any underlying biology, and that this is one of the things hampering psychiatric drug development. “We are still fully reliant on descriptive diagnoses that yield heterogeneous patient cohorts,” Steve Hyman told the audience at the European Congress of Neuropsychopharmacology (ECNP) Roadmap Meeting on Precision Psychiatry in Amsterdam in January.

Agilent buys Biocare for $950M

Mon, 09 Mar 2026 12:05:00 -0400

Agilent Technologies Inc. has agreed to buy Biocare Medical LLC for $950 million in cash in a bid to strengthen its pathology portfolio. The deal adds Biocare’s complementary immunohistochemistry antibodies, reagents and instruments portfolio to Agilent’s existing offerings, and expands its ability to serve a wider range of pathology laboratories across clinical and research settings.

MSD synthesizes α-synuclein PET agents

Fri, 06 Mar 2026 08:00:00 -0500

Merck Sharp & Dohme LLC (MSD) has prepared and tested new positron emission tomography (PET) agents for binding and imaging α-synuclein (SNCA) for the diagnosis of Parkinson’s disease.

US Fed Circuit protects 101 passage for some gene therapy patents

Tue, 24 Feb 2026 12:00:00 -0500

In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway.

Grail shares plunge after Galleri test misses primary endpoint

Fri, 20 Feb 2026 12:00:00 -0500

Grail Inc.’s share price dropped more than 50% in premarket trading Feb. 20 after it reported late the day before that the NHS-Galleri trial did not meet its primary endpoint. The U.K study, done though the National Health Service with 142,000 individuals enrolled, evaluated the ability of Grail’s Galleri multicancer early detection test to look for cancer-specific methylation patterns in blood.

AI transforming med tech in 2026; clinical need drives investments

Wed, 18 Feb 2026 12:00:00 -0500

Med-tech companies with an AI component in their solutions will certainly find investors willing to back them. AI after all, is being used to develop more effective, smarter technologies. However, investors will only deploy capital into innovations that address genuine clinical needs. The aging population is driving interest in devices targeting cardiovascular and musculoskeletal disorders, and other solutions geared toward neurological conditions, women’s health and diagnostics are also attracting investor attention.

Danaher to buy Masimo for $9.9B

Tue, 17 Feb 2026 12:00:00 -0500

Danaher Corp. agreed to acquire Masimo Corp. for $9.9 billion in a move to strengthen its diagnostics business. Under the terms of the agreement, Danaher will acquire all the outstanding shares of Masimo for $180 per share in cash, representing a 38.3% premium to Masimo’s last closing price.

AI-based tool for breast cancer cuts rate of interval cancers

Mon, 02 Feb 2026 12:00:00 -0500

An AI-based software developed by Screenpoint Medical BV could help detect breast cancers earlier and reduce the number of cancers that appear between routine screenings. In a trial of over 100,000 women, the use of the company’s Transpara Detection system resulted in a 12% reduction in the rate of interval cancers, compared to standard mammography screening. The results from the Mammography Screening with Artificial Intelligence study was published in the Lancet.

IND approval for Trace Biosciences’ nerve imaging agent

Mon, 02 Feb 2026 08:00:00 -0500

Trace Biosciences Inc. has obtained IND approval from the FDA for LGW16-03 (Nervetrace Dx), the company’s first nerve-specific fluorescent imaging agent. The IND clearance enables Trace to initiate a first-in-human study evaluating the safety and intraoperative performance of LGW16-03 in surgical settings.

4dmedical raises $105M to bolster U.S. CT:VQ lead

Thu, 29 Jan 2026 11:00:00 -0500

Australian respiratory imaging technology company 4dmedical Ltd. raised AU$150 million (US$105 million) in an institutional placement to accelerate U.S. adoption of its CT:VQ lung imaging software to bolster the company’s lead in software-based lung imaging.

En Carta Lyme disease test wins FDA breakthrough designation

Thu, 29 Jan 2026 11:00:00 -0500

En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.

Part B Medicare genetic testing spiked in 2024

Thu, 29 Jan 2026 11:00:00 -0500

A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the U.S. Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several recent examples of this kind of fraud.

Janssen Pharmaceutica reports TDP-43 PET imaging agents

Wed, 28 Jan 2026 08:00:00 -0500

Janssen Pharmaceutica NV has identified compounds targeting TAR DNA-binding protein 43 (TARDBP; TDP-43) acting as positron emission tomography (PET) imaging agents. They are designed for use in the diagnosis of neurological disorders.

FDA warns makers of HIV tests about test collection kits

Tue, 27 Jan 2026 11:00:00 -0500

The U.S. FDA’s Center for Biologics Evaluation and Research posted four warning letters to makers of HIV sample collection kits, an example of a shift in FDA enforcement in the IVD space that is still allowed after a historical loss in court.

[18F]fuzuloparib as PARP-targeted radiotracer for breast cancer

Tue, 27 Jan 2026 08:00:00 -0500

Breast cancer is the most frequently diagnosed malignancy worldwide. Inhibiting PARP-mediated DNA repair has emerged as a promising anticancer strategy, with PARP inhibitors (PARPis) demonstrating clinical efficacy particularly in tumors with defective homologous recombination repair, such as BRCA-deficient cancers.

Alzheimer’s finger-prick blood test investigated for diagnosis

Thu, 22 Jan 2026 11:00:00 -0500

A team of international researchers is investigating whether a finger-prick blood test could be used to help diagnose Alzheimer’s disease before symptoms appear. With current diagnostic methods relying on expensive brain scans and invasive lumbar punctures, the trial is exploring whether the simple test could offer a faster, cheaper, and more accessible route to identifying the disease.

Colostat, Genetype pairing sharpens cancer screening pathway

Fri, 16 Jan 2026 11:00:00 -0500

Rhythm Biosciences Ltd. launched a new genetype colorectal cancer risk assessment clinical test that incorporates clinical and lifestyle risk factors alongside its established 140-SNP polygenic risk score to identify people at elevated risk of colorectal cancer. The test supports more targeted screening and complements Melbourne-based Rhythm’s Colostat blood-based CRC detection test, which debuted in Australia in December 2025.

Crinetics Pharmaceuticals discovers new SSTR2 non-peptide-drug conjugates

Tue, 13 Jan 2026 08:00:00 -0500

Crinetics Pharmaceuticals Inc. has described drug conjugates consisting of a non-peptide moiety targeting G protein-coupled receptors (GPCRs) covalently linked to a chemotherapeutic moiety through a linker reported to be useful for the diagnosis and treatment of cancer.

Cellbxhealth restructures for growth

Mon, 12 Jan 2026 11:00:00 -0500

Cellbxhealth plc, previously called Angle plc, appointed CEO Peter Collins along with several non-executives to its board as it embarks on a new strategic direction. Over the past few months the company overhauled its management team, reduced its workforce by 60% and raised £8.2 million (US$11 million) as it changes focus from research to commercialization of its Parsortix system, a platform that captures and harvests circulating tumor cells (CTCs).

Radiotracer for positron emission tomography against PKM2

Fri, 09 Jan 2026 08:00:00 -0500

While Alzheimer’s disease is known for involving amyloid-b plaques and neurofibrillary tangles, it also involves metabolic dysfunction, further research into which could help scientists understand how the disease occurs and how it can be treated.

High pressure areas predicted for 2026 medical device landscape

Thu, 08 Jan 2026 11:00:00 -0500

It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.

Shanx secures €15M to accelerate rapid antimicrobial testing

Wed, 07 Jan 2026 11:00:00 -0500

Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.

Advanced Biomed sells Hong Kong subsidiary for $23k

Wed, 31 Dec 2025 11:00:00 -0500

Advanced Biomed Inc. reported Dec. 30 the sale of its wholly owned Hong Kong subsidiary, Advanced Biomed (HK) Ltd., and related intellectual property to buyer Wei Ha Hui for $23,000.