Medical Product Outsourcing

Patient Monitoring

Xandar Kardian’s Health Monitoring Radar Gains Clearance

This radar people-counting solution enables continuous and completely autonomous vital sign readings in real-time

Xandar Kardian 06.10.21

Chronic Disease

Koya Medical Receives FDA 510(k) Clearance for Active Compression Therapy System

Appoints additional executive leaders to support commercialization.

Charles Sternberg, Assistant Editor 06.02.21

FDA Grants Marketing Clearance to Helius Medical's PoNS Device

First tongue-delivered neuromodulation therapy provides new treatment option for patients living with gait deficit due to multiple sclerosis symptoms.

Michael Barbella, Managing Editor 05.24.21

Getinge Receives FDA Clearance for Multiple Products

Expands its Servo ventilator platform with new functionalities and options.

Charles Sternberg, Assistant Editor 04.22.21

J&J’s Veritas Vision System Receives FDA Clearance and CE Mark

Next-gen phacoemulsification innovation allows surgeons to guide through any lens density with less surge and more stability.

Charles Sternberg, Assistant Editor 04.21.21

Patient Monitoring

FDA Grants 510(k) Clearance to LivaNova’s B-Capta

An in-line, blood-gas monitoring system integrated into the S5 Heart-Lung Machine.

Charles Sternberg, Assistant Editor 04.20.21

Diagnostics

FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.

Charles Sternberg, Assistant Editor 04.15.21

Acutus Medical Receives FDA Clearance of AcQCross

Product family targets more than 300,000 annual U.S. electrophysiology and structural heart procedures.

Michael Barbella, Managing Editor 04.15.21

Chronic Disease

BD Receives 510(k) Clearance for Pristine Catheter

The clearance was supported by clinical data from a feasibility study with favorable primary patency rates observed out to 180 days.

Charles Sternberg, Assistant Editor 04.15.21

Surgical

Royal Philips’ SmartCT Application Software Receives FDA 510(k) Clearance

Helps enhance clinical confidence, smooths workflows, and increases productivity.

Charles Sternberg, Assistant Editor 04.06.21

Diagnostics

Optellum Receives FDA Clearance for Virtual Nodule Clinic

Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.

Charles Sternberg, Assistant Editor 03.23.21

Navient Receives Chinese Regulatory Clearance for ENT Applications

The surgical navigation system is already approved in the United States, Europe, Canada, South Korea, Brazil, and Taiwan.

Michael Barbella, Managing Editor 02.22.21

Eitan Medical Receives FDA Clearance for Sapphire Infusion System

Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.

Eitan Medical 01.20.21

AtriCure Receives FDA Clearance to Expand its Labeling for Cryo Nerve Block Therapy

The expansion includes adolescent patients who can benefit from cryo nerve block therapy during surgical procedures involving the chest wall.

Business Wire 01.20.21

Neurological

BioSerenity Achieves FDA Clearance for Wearable Device System

Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.

PRNewswire 01.07.21

keepMED Raises Funding for Regulatory Clearance of its Sleep Apnea Device

Company's technology mobilizes the user’s respiratory system to deliver just the amount of PAP needed, intermittently and with minimal airflow.

Business Wire 11.04.20

Hyperfine Research Receives FDA Clearance for Swoop Portable MRI System

Technology defines new product category for accessible, cost-effective point-of-care magnetic resonance imaging.

Business Wire 10.05.20

Digital Health

HD Medical Awarded FDA Clearance for HD Steth

Intelligent stethoscope with integrated ECG delivers instant cardiac insights.

Business Wire 09.11.20

Rapid ASPECTS Receives CADx Clearance From the FDA

AI-powered stroke imaging solution is the first to receive FDA advanced CADx clearance to raise reading capabilities for non-expert readers.

Business Wire 09.08.20

Venus Concept Wins FDA 510(k) Clearance for Venus Viva MD

The new skin rejuvenation solution with differentiated features allows clinicians to treat a wider range of conditions.

Globe Newswire 09.02.20

Gynesonics Receives FDA Clearance to Market Next-Generation Sonata System 2.1

Early launch in Europe contributes to significant procedural growth.

Business Wire 07.29.20

Beckman Coulter Receives FDA Clearance for Automated Microplate System

Processes up to 300 samples per hour with a maximum of 12 tests per sample.

PRNewswire 07.23.20

Getinge's Servo-air Mechanical Ventilator Receives 510(k) Clearance

Includes both Invasive and Non-Invasive (NIV) ventilation modes.

Getinge 07.07.20

Magnolia Medical Secures FDA Clearance for Expanded Steripath Gen2 Products

Devices become the first and only products indicated to reduce blood culture contamination.

PR Newswire 05.14.20

Mauna Kea's Next-Generation Cellvizio Platform Receives FDA Clearance, CE Marking

The new platform includes significant improvements and will enable major innovations, such as integrating easily with robotic systems.

Business Wire 05.13.20

CHF Solutions Receives FDA Clearance for Aquadex SmartFlow System

The system provides a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).

Globe Newswire 04.30.20

Kurin Receives FDA 510k Clearance for Its Push-Button Needle

Company's technology automatically and passively sidelines potential contaminants during blood culture collection.

Business Wire 04.24.20

Hologic Executive Joins Alydia Health as Chief Medical Officer

New hire also served as division chief of Obstetrics and Gynecology at Tufts Medical Center.

Business Wire 04.23.20

Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20

FDA Clears Bimini Health Tech's Dermapose Refresh Fat Transfer

Dermapose Refresh is an all-in-one microfat transfer system.

PR Newswire 04.22.20

HeartVista Forms Medical and Scientific Advisory Board

Governing body comprised of leaders from Stanford University and the University of Wisconsin.

Business Wire 04.16.20

FDA Clears EndoClot Plus's GI Submucosal Lifting Product

Product targets the rapidly growing U.S. endoscopic submucosal dissection market.

Business Wire 04.14.20

Diagnostics

FDA OKs COVID-19 Saliva Test

Self-collected spit test eliminates risk to those handling the samples.

PR Newswire 04.13.20

Mike on Medtech: COVID-19, Part 2

Mike Drues and Sean Fenske discuss issues involved with misinformation around products to help treat COVID-19 and relaxed regulatory rules.

Sean Fenske, Editor-in-Chief 04.08.20

Surgical

FDA OKs Nitiloop's Microcatheter to Treat Chronic Total Occlusion

Designed solely for antegrade approach, NovaCross is positioned to tap into the $500M CTO market.

PR Newswire 04.08.20

Cardiovascular

BioVentrix Names Co-Principal Investigator for Transcatheter Device Trial

Newly-appointed leader has served as the national or international principal investigator for more than 100 national and international randomized trials.

Business Wire 04.08.20

CloudCath Announces $12 Million Series A Financing

Funds will be used to advance commercialization of technology enabling remote, real-time complication monitoring for at-home dialysis.

Business Wire 04.07.20

PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables

Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.

PhysIQ 04.07.20

Surgical

FDA Clears CrossBay Medical's CrossGlide Endometrial Tissue Sampler

Endometrial biopsy procedures can be done gently, effortlessly, and without a tenaculum.

Business Wire 04.02.20

FDA OKs Outset's Table System for Home Dialysis

First new device cleared for home hemodialysis in 15 years.

PR Newswire 04.02.20

Diagnostics

Biomerica Working With N.Y. Medical School on COVID-19 Antibody Test

Once developed and scaled-up, the company’s existing production capacity could allow for more than 1 million tests per month.

Globe Newswire 04.02.20

Virgin Orbit Designs New Mass-Producible Ventilator

Aims to have a functioning, deployable bridge ventilator in production in early April.

Virgin Orbit 04.01.20

R&D & Design

Why Outsourcing Is in: Piecing Out Projects Makes Sense

Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.

Dawn A. Lissy, President & Founder, Empirical 04.01.20

Diagnostics