Device Sectors
Regulatory News
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Chronic Disease
ESTRO24: Elekta Releases Evo AI-Powered, Adaptive CT-Linac
The CT-Linac touts powerful AI capabilities and anatomy-specific algorithms.Sam Brusco, Associate Editor 05.03.24
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Diagnostics
FDA Takes Action to Ensure Safety and Effectiveness of Laboratory-Developed Tests
A final ruling has amended FDA regulations regarding IVDs, and will outline the roll out of general enforcement over a four-year period.Rachel Klemovitch, Assistant Editor 05.03.24
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Digital Health
Dramatic Growth Predicted for Global Digital Twins Market
The digital twins adoption rate is rapidly increasing across industries but challenges with security and interoperability have yet to be addressed.Michael Barbella, Managing Editor 05.03.24
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Diagnostics
Beckman Coulter Introduces CytoFLEX Nano Flow Cytometer
CytoFLEX detects, counts, and characterizes nanoparticles using a single analytical instrument.Michael Barbella, Managing Editor 05.03.24
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Chronic Disease
Elekta Acquires IP for Philips' Pinnacle Treatment Planning System
The aim is further innovation in radiation therapy treatment planning and workflow optimization.Sam Brusco, Associate Editor 05.03.24
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Digital Health
LifeMD and Withings Health Solutions Offer Real-Time Weight Loss Monitoring Solution
LifeMD partners with Withings Health Solutions for real-time, at-home monitoring, and body composition devices.Rachel Klemovitch, Assistant Editor 05.03.24
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Cardiovascular
ConKay Medical Systems Raises $1.8 Million in Seed Funding
The money will support the company's growth and development of its one-size-fits-all annular repair catheter system.Michael Barbella, Managing Editor 05.02.24
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Patient Monitoring
Owlet's Dream Sock OTC Infant Pulse Oximeter OK'ed in Europe
Dream Sock comfortably wraps around a baby's foot and is used for routine, in-home surveillance.Sam Brusco, Associate Editor 05.02.24
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Cardiovascular
HeartBeam Begins Study of its AIMIGo System
Trial aims to demonstrate the equivalence of ECG waveforms between the AIMIGo synthesized 12-lead ECG and a standard 12-lead ECG.Michael Barbella, Managing Editor 05.02.24
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Diagnostics
FDA OKs United Imaging's Breakthrough 5T MRI
uMR Jupiter 5T is the first ultra-high field MRI system cleared for whole body applications.Sam Brusco, Associate Editor 05.01.24
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Neurological
Soterix Releases MxN-GO EEG for Wire-Free HD-tES and EEG
The system is meant for research applications that need electrical stimulation and brain activity recording in mobile and natural environments.Sam Brusco, Associate Editor 05.01.24
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Diagnostics | Digital Health
Portable Stethoscope for Detecting Subtle Lung Sounds Premieres in U.S.
The next-generation ChestPal Pro is touted as the only commercially available device that can detect lung crackles and wheezes.Michael Barbella, Managing Editor 05.01.24
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Chronic Disease
ESTRO24: GE HealthCare to Reveal AI-Driven, Personalized Oncology Solutions
The company will introduce Revolution RT radiation therapy CT simulation and an updated Intelligent Radiation Therapy platform.Sam Brusco, Associate Editor 05.01.24
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Chronic Disease
Radformation Buys Limbus AI to Boost Cancer Care Solutions
The duo plans to integrate the best features of each of their systems to offer advanced, AI-driven contouring for radiation therapy.Sam Brusco, Associate Editor 05.01.24
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Cardiovascular
Studies Support Favorable Outcomes With Edwards' SAPIEN TAVR
All Edwards TAVR platforms demonstrated excellent paravalvular leak results, according to the data.Michael Barbella, Managing Editor 05.01.24
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Cardiovascular | Neurological
Route 92 Medical Gets FDA OK for FreeClimb 54 Reperfusion System
FreeClimb 54 can be used to remove distal clots, should first-line therapies fail to completely remove the clot.Sam Brusco, Associate Editor 04.30.24
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Surgical
Medline to Acquire Ecolab's Surgical Solutions Biz
The acquisition will provide Medline with sterile drape solutions for surgeons, patients, and operating room equipment.Sam Brusco, Associate Editor 04.30.24
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Chronic Disease | Diagnostics
Toku's AI to Spot Chronic Kidney Disease Through the Eye Wins FDA Breakthrough Nod
MyKidneyAI leverages AI to analyze retinal images from routine eye exams to spot elevated CKD risk in people with diabetes.Sam Brusco, Associate Editor 04.30.24
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Chronic Disease | Diagnostics
FDA OKs Fully Autonomous AI for Portable Diabetic Retinopathy Screening
The AI diagnoses referable diabetic retinopathy from retinal images taken by a handheld camera.Sam Brusco, Associate Editor 04.30.24
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Digital Health
Viz.ai Study Shows Reduced Mortality Rates for Pulmonary Embolism
Company’s artificial intelligence technology indicates a 74% reduction in in-hospital PE mortality rates.Michael Barbella, Managing Editor 04.30.24
