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Evaluations for the EU: The Impact on Testing & Lab Services
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Breaking News
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Supply Chain
Device Sectors
Alex Gorsky to Step Down as J&J CEO in 2022
CEO role will transfer to Joaquin Duato, currently Vice Chairman of the company's Executive Committee.
PR Newswire
08.20.21
Data Show Theranova May Reduce Cardiovascular Events, Hospitalizations
Study of Colombian dialysis patients indicates cardiovascular events were 35 percent lower for patients on HDx therapy enabled by Baxter's Theranova dialyzer.
Business Wire
08.20.21
CloudCath, American Renal Associates Partner on Dialysis Study
Companies are testing a remote monitoring platform for in-home use by peritoneal dialysis patients.
Business Wire
08.20.21
908 Devices Appoints Marcia Eisenberg to its Board
Third board appointment of 2021 supports long-term vision for the company’s technology platform.
Business Wire
08.20.21
Surgical
First Surgery Using the MIRA Surgical Platform Successfully Completed in Nebraska
The procedure was performed as part of a clinical study of MIRA under an Investigational Device Exemption from the FDA.
Virtual Incision
08.20.21
Cardiovascular
Biomedical Engineers Grow 3D Bioprinted Blood Vessel
Paves the way for possible cardiovascular drug advancements with better precision.
Texas A&M Engineering
08.19.21
Neurological
FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients
Expanded depression indication further demonstrates company’s leadership position.
GlobeNewswire
08.19.21
Glaukos' PRESERFLO MicroShunt Approved in Australia
Product is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma.
Business Wire
08.19.21
Digital Health
iCAD Signs Global Distribution Agreement With Sectra
Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.
Globe Newswire
08.19.21
Butterfly Network Building New Corporate Headquarters in Massachusetts
New facility will have the capacity for approximately 275 people with the ability to expand further.
Business Wire
08.19.21
Cala Health Expands its Executive Team
Steve Higa and Greg Schulte add deep strategic experience, operational excellence to the company's management.
Business Wire
08.19.21
Cardiovascular
Abiomed's Impella ECP Heart Pump Granted Breakthrough Status
The world’s smallest heart pump, according to the company.
Business Wire
08.19.21
Diagnostics
EchoNous’ Lexsa Linear Probe Cleared by FDA
An ultra-portable device capable of producing diagnostic-quality images rivaling those from larger, more expensive cart-based units.
EchoNous
08.19.21
Diagnostics
Illumina Closes $7.1B GRAIL Deal Despite Antitrust Challenges
GRAIL will remain a separate and independent unit, pending ongoing regulatory and legal review.
PR Newswire
08.19.21
Electronics
Freudenberg Medical Increases Capabilities for Sensor Integration
Positions the company to work with sensors such as temperature and pressure sensors, entire sensor arrays, and fiber optic sensors.
Freudenberg Medical
08.18.21
Diagnostics
FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device
New authorization includes the unsupervised self-collection of saliva for COVID-19 testing.
Spectrum Solutions
08.18.21
Diagnostics
SyntheticMR Extends Collaboration Agreement with Siemens Healthineers
Enables Siemens Healthineers to market, sell and distribute SyntheticMR’s product package SyMRI NEURO to its customers in global markets.
SyntheticMR
08.18.21
Gynesonics Appoints David Pacitti as Board Chair
Current president and head of Siemens Healthineers in the Americas brings strong commercial experience to the Board of Directors.
Business Wire
08.18.21
Guard Medical Enrolls First Patients in NPseal Post-Market Study
NPseal is a wearable dressing with an integrated pump that establishes and maintains negative pressure with just a few pinches.
Business Wire
08.18.21
Probo Medical Acquires Tenvision
Deal is the fourth acquisition for the company this year.
Business Wire
08.18.21
Breaking News
Getinge Donates Extensive Medical Equipment to Ukraine
Olympus Names Julien Sauvagnargues CEO of the Americas
Mark Pugh Assumes CEO Role at Theragenics
Art Taylor Named to Endologix Board of Directors
Michael Bourque Named Chief Financial Officer at Inogen
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
View More >