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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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U.S. Supreme Court

Loper Bright no free pass where FDA’s LDT rule is concerned

Feb. 26, 2025
By Mark McCarty
The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.
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U.S. Capitol building, Washington D.C.

FDA’s LDT rule, CDS guidance combine to complicate regulatory life

Feb. 26, 2025
By Mark McCarty
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
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brain depression
Patents

Cornell researchers ID enlarged brain network in depressed individuals

Feb. 25, 2025
By Simon Kerton
Researchers from Weill Cornell University filed for protection of discoveries made from investigations into the mechanisms underlying depression, which revealed that a specific brain network is significantly larger in individuals affected by depression.
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SonioAI

US FDA clears Sonio Suspect for fetal anomaly detection

Feb. 24, 2025
By Annette Boyle
The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.
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Polygenic risk score

Seonix Bio sees future in genetic test for glaucoma

Feb. 20, 2025
By Annette Boyle
Up to 50% of glaucoma cases have a genetic component, a factor which could significantly change the screening recommendations and monitoring of patients – if they know their risk. Seonix Pty. Ltd. has a vision for making that genetic information easier to obtain and use to guide care with its Sightscore saliva-based test.
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EEG earpiece
Patents

EEG earpiece predicts seizures up to an hour before onset

Feb. 20, 2025
By Simon Kerton
The first patenting from Theta Neurotech Inc. sees the company’s co-founders describe their development of a wearable earpiece that uses an electroencephalography technology and machine learning algorithms to alert epilepsy patients 30 to 60 minutes before they have a seizure.
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BC wearable
Patents

Wearable developed for breast cancer self-examination, detection

Feb. 19, 2025
By Simon Kerton
The latest patenting from Canan Dagdeviren seeks protection for their wearable, conformable ultrasound breast patch that enables standardized and reproducible image acquisition over the entire breast with less reliance on operator training and applied transducer compression.
Read More
Australian money

Harrison.ai raises AU$179M in series C round to fuel global expansion

Feb. 18, 2025
By Tamra Sami
Harrison.ai raised AU$179 million (US$112 million) in a series C round to expand its radiology and pathology solutions across the U.S., Europe, the Middle East, Africa and Asia Pacific.
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Conceptual image for brain cancer treatment

Radiopharm’s F18-Pivalate successfully detects brain metastases

Feb. 18, 2025
By Tamra Sami
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 (F18-Pivalate) successfully detected brain metastases in a variety of primary solid tumors in a phase II study.
Read More
Australian money

Harrison.ai raises AU$179M in series C round to fuel global expansion

Feb. 14, 2025
By Tamra Sami
Harrison.ai raised AU$179 million (US$112 million) in a series C round to expand its radiology and pathology solutions across the U.S., Europe, the Middle East, Africa and Asia Pacific.
Read More
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