FDA OKs Vivos Therapeutics’ oral devices for severe sleep apnea
In much the same way that they’re designed to expand the upper airway, Vivos Therapeutics’ oral appliances have now expanded their FDA indications.
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Continue Reading »Recor Medical claims first FDA approval in renal denervation for stubbornly high blood pressure.
Recor Medical’s renal denervation approach tackles high blood pressure that hasn’t responded to medications or changes in lifestyle.
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Continue Reading »FDA Allege Wavi is Selling Unapproved Neurological Device
While the company states the device doesn’t need IDE or premarket approval because they claim its use is for research purposes only, FDA disagrees.
While the company states the device doesn’t need IDE or premarket approval because they claim its use is for research purposes only, FDA disagrees.Read the full article at: www.mddionline.com
Continue Reading »Kidney monitor maker Potrero Medical files for bankruptcy
The former Fierce Medtech Fierce 15 winner announced it has begun to voluntarily restructure its equity through pre-negotiated terms filed in Delaware bankruptcy court.
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Continue Reading »Eko AI spots murmurs at 2x the rate of other stethoscopes: study
Shortly after launching its Sensora platform, Eko Health has published a study detailing the real-world performance of its heart disease detection AI.
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Continue Reading »RefleXion nets $105M to roll out its PET-guided cancer radiotherapy
RefleXion Medical won an FDA clearance earlier this year for its image-guided radiation treatment for lung and bone cancers.
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Continue Reading »Medtronic rolls out newly acquired atrial appendage implant for afib patients
The Penditure is a small, curved clip made to seal off a small pocket in the heart’s left atrium, where potentially dangerous blood clots are more likely to form if a person has an irregular heartbeat.
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Continue Reading »Lung chip model offers new insights into how radiation damages the lungs
The lung is one of the tissues most sensitive to radiation in the human body. People exposed to high radiation doses following nuclear incidents develop radiation-induced lung injury (RILI), which affects the function of many cell types in the lung, causing acute and sustained inflammation, and in…
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Continue Reading »HistoSonics nets de novo nod for liver tumor-blasting ultrasound
For the first time, the FDA has greenlit histotripsy technology, which uses ultrasound waves to noninvasively destroy a designated tissue.
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Continue Reading »New virus diagnosis device gives lab-quality results within just three minutes
A virus diagnosis device that gives lab-quality results within just three minutes has been invented by engineers at the University of Bath, who describe it as the ‘world’s fastest Covid test’.
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