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BioWorld - Saturday, April 11, 2026
Home » Topics » Diagnostics, Medical technology

Diagnostics, Medical technology
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AI medical illustration

AI transforming med tech in 2026; clinical need drives investments

Feb. 18, 2026
By Shani Alexander
No Comments
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.
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Masimo MightySat pulse ox

Danaher to buy Masimo for $9.9B

Feb. 17, 2026
By Shani Alexander
No Comments
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.
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Mammography screening

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

Feb. 2, 2026
By Shani Alexander
No Comments

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.


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4DMedical Respiratory Imaging

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

Jan. 29, 2026
By Tamra Sami
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.
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En Carta EC Pocket Lyme test

En Carta Lyme disease test wins FDA breakthrough designation

Jan. 29, 2026
By Shani Alexander
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.
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Gloved hand holding test tube marked for ataxia-telangiectasia genetic test

Part B Medicare genetic testing spiked in 2024

Jan. 29, 2026
By Mark McCarty
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.
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FDA headquarters signage

FDA warns makers of HIV tests about test collection kits

Jan. 27, 2026
By Mark McCarty
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.
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Finger prick

Alzheimer’s finger-prick blood test investigated for diagnosis

Jan. 22, 2026
By Shani Alexander
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.
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Illustration of colon with inset showing cancer

Colostat, Genetype pairing sharpens cancer screening pathway

Jan. 16, 2026
By Tamra Sami
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.
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Rows of red and blue game pieces with hybrid center piece

Cellbxhealth restructures for growth

Jan. 12, 2026
By Shani Alexander
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).
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