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Leica Biosystems Receives FDA 510(k) Clearance for Aperio GT 450 DX Digital Pathology System with...
WFRV 5 Green Bay· 5 days agoLeica Biosystems is pleased to announce that its flagship digital pathology system, Aperio GT 450 DX, has received 510(k) clearance from ...
Spinal Simplicity announces FDA 510(k) Clearance of its Sacroiliac Joint System, the Patriot-SI...
PRWeb· 3 days agoSpinal Simplicity has been granted patent protection for the novel Patriot-SI cannulated and...
Apple Watch series AFib monitor getting FDA medical certification
Android Headlines· 2 days agoThe Apple Watch series AFib feature has received new approval from the FDA. From now on, the results...
Cytovale’s sepsis diagnostic test demonstrates 97.5% NPV in latest study
Medical Device Network via Yahoo Finance· 1 day agoThe IntelliSep tool was used to quickly diagnose and assess the severity of the sepsis. The test was...
Your Apple Watch's AFib history could soon be used in clinical studies
ZDNet· 1 day agoApple has made clear that it wants to play a role in the health care market, and now, it's one step...
Senseonics gets FDA clearance to pair CGM implant with insulin pumps
MedTech Dive via Yahoo Finance· 4 days agoSenseonics can now get iCGM status via the 510(k) pathway by complying with special controls the FDA...
Monogram Provides Regulatory Update Following Meeting with FDA
Digital Journal· 3 days agoFood and Drug Administration (the "FDA"). On April 19, 2024, Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission ...
Love Is Like Oxygen (Unless FDA Thinks You Get Too Much, You Get Too High): FDA Issues a Warning...
JD Supra· 2 days agoOne of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much ...
Cardinal receives FDA warning letter over unapproved syringes
MedTech Dive via Yahoo Finance· 2 days agoThe agency has recently increased scrutiny of plastic syringes made in China because of safety...
Variantyx raises $36m to commercialise genomic diagnostics
Medical Device Network via Yahoo Finance· 5 days agoMultiple companies have recently released genetic solutions. In September 2023, 23andMe received 510...