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Home » Authors » Annette Boyle

Articles by Annette Boyle

Spotitearly dog

Spotitearly dogs AI to diagnose early cancer with tailwagging 95% accuracy

Dec. 6, 2024
By Annette Boyle
Bring your dog to work day looks a little different at Spotitearly. The Tel Aviv-based company asks its canine workers to bring their whole selves to the job – particularly their finely trained noses – to help suss out cancer in breath samples. The dogs’ unique capabilities are interpreted by AI to capture canine indicators humans might miss and the combo has remarkably high accuracy, 93% or better in three of the four common cancers tested.
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Field medical

Field Medical wins FDA breakthrough designation

Dec. 5, 2024
By Annette Boyle
The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.
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Judge's gavel with US flag

Jury awards Insulet $452M against Eoflow in trade secrets case

Dec. 5, 2024
By Annette Boyle
A federal jury awarded Insulet Corp. $452 million against Eoflow Co. Ltd., concluding that Eoflow and other defendants stole trade secrets to create the Eopatch, a device with striking similarities to Omnipod, Insulet’s market-dominating tubeless insulin pump.
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Dreem 3S

Beacon’s Dreem(s) come true with FDA authorization of PCCP

Dec. 4, 2024
By Annette Boyle
Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts electroencephalograms as users sleep. The authorization allows Beacon to incorporate updates to the Dreem 3S sleep-staging algorithm acquired through machine learning without submitting a new 510(k) application.
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U.S. FDA headquarters

FDA finalizes predetermined change control plans

Dec. 4, 2024
By Annette Boyle
At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,” aims to support the iterative improvement central to many algorithms while minimizing potential issues with safety and efficacy.
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Woman  in military clothing talking with psychologist

Wave cheers MERT’s FDA breakthrough device designation for PTSD

Dec. 3, 2024
By Annette Boyle
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
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Evie Ring - Movano

Movano rings up FDA pulse ox clearance for Eviemed

Dec. 2, 2024
By Annette Boyle
Movano Inc., dba Movano Health, added some clinical-grade glitz to its Evie ring with a U.S. FDA clearance for the built-in pulse oximeter. Movan’s stock shot up from an all-time low within minutes of the announcement on Dec. 2, as the clearance breathes new life into Movano’s plans to position the ring as a medical device.
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Minuteful Kidney test kit box

Healthy.io’s app makes CKD detection a snap

Nov. 22, 2024
By Annette Boyle
Nine out of 10 people with chronic kidney disease have no idea their kidneys are impaired, largely because of a lack of routine testing for albuminuria, one of the earliest biomarker for the disease.
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Medtronic CoreValve

Medtronic, Tempus ALERT to disparities in valve replacement

Nov. 21, 2024
By Annette Boyle
Medtronic plc and Tempus AI Inc. launched the ALERT study to better understand and address the racial, ethnic, gender and geographic disparities associated with guideline-recommended treatments for aortic stenosis and mitral valve regurgitation. Currently, white patients represent 91% of people who receive TAVR procedures, a minimally invasive procedure that sharply reduces complications and improves quality of life in patients with narrowed heart valves.
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Female hands holding heart on cardiogram
Healing the health divide

New diagnostics, trials address deadly disparities in women’s cardiac care

Nov. 20, 2024
By Annette Boyle
While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.
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