FDA grants Protaryx Medical clearance for transseptal puncture device

The system offers zero-exchange delivery with a unique atraumatic design to reduce steps and eliminate rewiring during access ...
Healthcare Packaging

Elidah Secures FDA Clearance for At-Home Post-Prostatectomy Treatment

The non-invasive therapy signals a strategic push into the growing home healthcare market for post-surgical rehabilitation.
Business Insider

ProSomnus® Receives FDA Class II Clearance for RPMO2 OSA Device

SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today ...

ProSomnus secures FDA clearance for RPMO2 device

RPMO₂ features a fully embedded oximeter over maxillary dentition, using buccal vestibule mucosa behind the upper lip.
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US FDA medical device clearance demystified – what investors need to know

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
MobiHealthNews

iHealth gets FDA clearance for medical-grade pulse ox

iHealth Labs, a subsidiary of China-based medical device company Andon Health, has received FDA clearance for a wireless fingertip pulse oximeter, which will be a distinct offering from the consumer ...
Macworld

Apple’s Studio Display XDR gets medical imaging clearance from the FDA

Macworld reports Apple’s Studio Display XDR medical imaging calibrator received FDA 501(k) clearance, marking the company’s entry into professional medical display technology. The calibrator becomes ...