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Related Content

Breakthrough Device Designation Granted for New Neuromodulation Platform

In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
Business Wire 09.22.21
Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
Business Wire 09.22.21
First CellFX Procedure Performed in Canada

Pulse Biosciences expands its controlled launch of the CellFX System into the country.
Business Wire 09.22.21
CareDx Appoints Hannah Valantine to its Board

Valantine is a professor of Medicine at Stanford and the former National Institutes of Health chief scientific officer for Scientific Workforce Diversity.
Globe Newswire 09.21.21
Diagnostics

Babson Diagnostics Raises $31 Million in Series B Funding

Money will be used to help drive commercialization of customer-first, highly accessible diagnostic blood testing.
Business Wire 09.20.21
Paragonix Launches Global Registry for Studying Donor Lung Preservation

Registry will capture data on how organ preservation and transportation impact patient outcomes in lung transplantation.
Business Wire 09.20.21
Picarro Unveils EtO Gas Concentration Analyzer

Analyzers are now available for CEMS, stack testing, fenceline, and ambient monitoring systems.
PR Newswire 09.20.21
Diagnostics

FDA Clears Inova Diagnostics' Digital Multi-Analyte System

The product, Aptiva, received CE marking in August 2020.
PR Newswire 09.20.21
Cardiovascular

FDA Approves Abbott's Portico with FlexNav TAVR System

Self-expanding TAVR valve features intra-annular (within the native valve) leaflets.
PR Newswire 09.20.21
Medical Devices Market to Top $671.49 Billion by 2027

Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.
Precedence Research 09.16.21
Improved Outcomes Proven With Insulet’s Omnipod 5 System

Studies show the automated insulin delivery system improved HbA1c nearly one percentage point in kids and 0.60 percent in adolescents and adults.
Business Wire 09.16.21
Digital Health

The Benefits of Computer Vision Technology for Healthcare Applications

How new technology could save millions of dollars and help patients receive better treatment.
Henry Bell, Head of Product at Vendorland 09.13.21
Patient Monitoring

Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.
Business Wire 09.13.21
Contract Manufacturing | R&D & Design

Midwest Products & Engineering Acquires MindFlow Design

Design firm to enhance MPE's concept to completion model.
PR Newswire 09.10.21
Glytec Appoints Nausheen Moulana as Chief Technology Officer

Engineering and technology veteran to lead company’s product vision and support growing demand for insulin dosing software.
Business Wire 09.09.21
Diagnostics

Roche to Acquire Long-Term Partner TIB Molbiol

Expands PCR-test portfolio in the fight against new infectious diseases.
GlobeNewswire 09.09.21
Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

The new space houses a full-scale operating room for robotics testing as well as R&D and company operations.
Business Wire 09.09.21
908 Devices Develops New Data Integrations With Key Industry Partners

Integration of Sartorius SIMCA and Securecell Lucullus PIMS with REBEL Spent Media Analyzer allows for data-driven decisions.
Business Wire 09.09.21
Luis J. Malavé Joins Integrity Applications Board

New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.
Globe Newswire 09.08.21
Neurological | Software & IT

Mayo Clinic, Google Research AI Software Could Boost Brain Stim Devices

Algorithm may help understand which brain regions directly interact with one another.
Mayo Clinic 09.07.21
SCIEX Debuts the ZenoTOF 7600 System

System delivers new capabilities for life science research and biotherapeutic development.
Business Wire 09.02.21
Global Brain Computer Interface Market to Top $1.6B by 2028

Growth partly expected from collaborations among various research institutes to develop bran disease diagnostics.
Globe Newswire 09.02.21
Diagnostics

GE Healthcare Reveals AMX Navigate Portable X-Ray System

Helps address technologist stress and strain and improve efficiency.
Business Wire 09.01.21
Cardiovascular

CorWave Completes Preclinical Study on its Cardiac Pump

Data confirmed the ability of the CorWave pump to provide chronic circulatory support with exceptional hemocompatibility.
Business Wire 08.27.21
Stanislav Glezer Joins Inogen as Chief Medical Officer

New hire most recently worked for Becton, Dickinson and Company as worldwide vice president of Medical Affairs for Diabetes Care.
Business Wire 08.24.21
Packaging & Sterilization

Amcor Launches Enhanced Heat Seal Coating Technology

New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.
Amcor 08.23.21
Hyperfine Welcomes Dave Scott as President and CEO

New leader worked for Apple, Google (Verb Surgical), and led the design team for Intuitive Surgical's visualization platform.
Business Wire 08.23.21
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
Materials

Developing Next Generation Implants with Bioresorbables—A Medtech Makers Q&A

To help restore natural anatomy following a medical procedure, some device makers are curious about bioresorbable molded devices.
HD Medical Appoints Shaun Setty as Chief Medical Officer

Cardiothoracic surgeon positions the company for growth in the CVD detection and monitoring market.
Business Wire 08.13.21
First Clinical Use of SoundBite Medical's Active Wire Platform

Doctors tout strong results with the company's Active Wire 0.014-inch platform in severely calcified peripheral lesions.
Business Wire 08.13.21
Diagnostics

BD Launches FACSymphony A1 Benchtop Cell Analyzer

Brings sophisticated flow cytometry capabilities to laboratories of all sizes.
BD 08.12.21
Digital Health

Four Real-World Applications for Voice Tech in Healthcare

How voice enablement is impacting seniors and healthcare professionals.
Bruce Ryan, Director of Engineering, Harman Embedded Audio 08.11.21
Cardiovascular

Philip Morris International Acquires OtiTopic

PMI will use the purchase to grow its pipeline of ‘Beyond Nicotine’ inhaled therapeutic products.
Philip Morris International Inc. 08.11.21
Surgical

FDA OKs Boston Scientific's EXALT Model B Single-Use Bronchoscope

Designed for bedside procedures in the ICU and OR.
PR Newswire 08.10.21
Neurological | Software & IT

FDA OKs SpinTech's STAGE MRI Software

Allows scanning the entire brain in roughly five minutes.
PR Newswire 08.09.21
Diagnostics | Digital Health | Software & IT

GE Healthcare, AWS Partner to Transform Care Delivery

AI-based imaging applications and Edison Health Services platform on AWS.
Business Wire 08.09.21
Materials

Pandemic has Accelerated Nearshoring Medtech Materials

Buying materials from overseas may be cost-effective, but it can create an environment with less collaboration and less room for innovation.
Michael Barbella, Managing Editor 08.06.21
Neurological

FDA Approves ZOLL's remedē for Central Sleep Apnea

Transvenous phrenic nerve stimulation for moderate to severe CSA approved.
Business Wire 08.06.21
ASTM International, NSERC HI-AM Network Sign MOU

The agreement will support the development of additive manufacturing standards.
ASTM International 08.05.21
Draper Makes Advances in Extracorporeal Membrane Oxygenation

Develops artificial lung technology with $4.9 million army grant.
08.04.21
Cardiovascular

FDA OKs Abbott's AI OCT Imaging for Vessels in the Heart

Ultreon 1.0 Software is the first-of-its-kind imaging software according to the company.
PR Newswire 08.04.21
Materials

Smaller Devices Require More Efficient Material Integration

Silicones are becoming increasingly well-suited for implantable medical devices and combination products.
Michael Barbella, Managing Editor 08.03.21
Digital Health

Hello Heart Raises $45M to Expand Digital Heart Health Platform

Series C financing was led by IVP and includes existing investors.
Business Wire 08.02.21
Non-Profit Group Launches Initiative to Diversify Medtech Workforce

Collaborative Community developing ways to recruit and retain minority physicians, researchers, and other stakeholders in research and product development.
Business Wire 08.02.21
Materials

Pandemic Underscores Importance of Medtech Material Innovation

Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.
Michael Barbella, Managing Editor 07.30.21
Foxx Life Sciences Expands with Two New Manufacturing Facilities

The new locations add four additional Single Use Technology Cleanrooms.
Foxx Life Sciences 07.30.21
Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy

With previous roles at Philips and Stryker, Dr. Venkataraman will bring his expertise to Promaxo’s MRI and robotic platform.
Business Wire 07.30.21
Cardiovascular | Digital Health

BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status

Augments guideline-directed use of heart failure medications.
PR Newswire 07.30.21
Cardiovascular

Successful First Human Use of Foldex's Biopolymer Mitral Heart Valve

Second product from Tria Biopolymer Valve portfolio to move into human study.
Business Wire 07.30.21
Chronic Disease

Rice Team Building Insulin-Producing Implant for Type 1 Diabetes

JDRF funds creation of implant to automatically regulate blood glucose levels.
Jade Boyd, Rice University 07.27.21
Materials

Disinfectant Resistance is Crucial in Medtech Material Selection

Understanding the kinds of materials that stand up to healthcare-grade disinfectants can help ensure device longevity.
Michael Barbella, Managing Editor 07.27.21
Tasso-M20 Device Earns CE Mark Certification

Device is being used across multiple virtual clinical trials to gather unprecedented amounts of pharmacokinetic data.
Business Wire 07.23.21
Materials

Electronics Integration Impacting Medtech Materials

Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.
Michael Barbella, Managing Editor 07.23.21
BD Acquires Velano Vascular

Will use innovative needle-free blood draw technology to reduce pain and discomfort of multiple needlesticks.
BD 07.22.21
ONI Welcomes Dr. Tyler Ralston as Chief Technology Officer

Visionary technology creator will help drive future innovations in single cell microscopy applications.
Business Wire 07.20.21
Diagnostics

Nova POC Creatinine/eGFR Method More Accurate Than Lab Method

One of the first studies to compare the accuracy of POC creatinine/eGFR devices to iohexol mGFR method yields promising results.
Nova Biomedical 07.20.21
Chronic Disease

Integra Highlights Data from Diabetic Foot Ulcer Study

Positive clinical outcomes for PriMatrix dermal repair scaffold for management of hard to heal diabetic foot ulcers.
GlobeNewswire 07.20.21
Study Confirms Benefits of ZOLL's Implantable Sleep Apnea Device

Data show sustained improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through five years.
Business Wire 07.19.21
Catheter and Medical Design Hires Two Industry Experts

Rich Abraham and Scott Olson will lead business development and customer relationships in the East Coast and Midwest markets.
Catheter and Medical Design LLC 07.16.21
Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027

Innovation and product launches are expected to drive growth.
Business Wire 07.14.21
Digital Health

DataRobot Launches AI for Health Incubator

Company is accelerating critical healthcare research to help physicians and medical professionals better leverage AI.
Business Wire 07.14.21
VistaMed, OneProjects and Tyndall Receive €5.1 million to Improve Treatment of Cardiac Arrhythmias

Project aims to provide a catheter to deliver direct 3D, intraprocedural analysis of the success of cardiac ablation, in the treatment of atrial fibrillation.
VistaMed 07.14.21
Second Sight Touts Cortical Prosthesis Study Results

Preliminary findings show participants benefit from Orion Visual Cortical Prosthesis.
Business Wire 07.14.21
Substantial Growth Predicted for Global Ventilators Market

Aging population, increasing infectious disease rates to drive growth through 2026.
Market Study Report 07.13.21
Cardiovascular

HeartFlow Completes Patient Enrollment in the PRECISE Trial

More than 2,000 patients enrolled in randomized controlled trial to evaluate a precision-testing pathway for suspected coronary artery disease.
Business Wire 07.13.21
Fluid Management System Market to be Worth $23.2 Billion By 2028

North America dominated the global market for fluid management system in 2020 and will continue that dominance over the next seven years.
Polaris Market Research 07.13.21
Digital Health

Heartbeat Health Raises $20 Million Series B Funding

Money will be used to expand virtual heart care.
Business Wire 07.12.21
Xenter Appoints Four Healthcare Industry Leaders to its Board

Company also closes a $12 million Series A stock offering.
Business Wire 07.12.21
3D/Additive Manufacturing

Desktop Health Adds PhonoGraft Platform to Its Technology Platform

Will support the body’s functional and morphological regeneration of the tympanic membrane.
Desktop Health 07.09.21
Contraline Expands Board of Directors

Medical device industry veteran Martin J. Emerson has joined the company's board.
Business Wire 07.09.21
Cardiovascular

Enrollment Underway in Philips' WE-TRUST Stroke Study

Will assess impact of the Direct to Angio Suite workflow in improving patient outcomes.
Philips 07.07.21
Santen Granted Health Canada Approval of PRESERFLO MicroShunt

The product is currently available in Europe.
Business Wire 07.07.21
EU MDR Preparedness: How Is COVID-19 a Factor?

Properly plan ahead so that your company can tackle regulatory hurdles without any struggles.
Jon Speer, Founder of Greenlight Guru 07.06.21
Safeguard Medical Buys PerSys Medical

Brings broadest portfolio of life-saving medical equipment, tech, services to first responders.
PR Newswire 07.01.21
OnLume Surgical Completes $7 Million Series A Financing

Funding supports commercial launch of novel fluorescence image-guided surgery system.
Business Wire 07.01.21
Ultra-Fast COVID-19 Antibody Test Under Development

Test could be used worldwide to help prioritize who should receive coronavirus vaccines.
Business Wire 07.01.21
Surgical

The Future of AI and OR Medical Devices

Bringing artificial intelligence to the operating room.
Michael Hutton, Upper GI Specialist at Royal Cornwall Hospitals NHS Trust 06.30.21
Cardiovascular

The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology

Reviewing the innovative technology’s history and impact on persistent atrial fibrillation.
Steven Mickelsen, MD, Chief Translational Science Officer, Acutus Medical 06.29.21
Wellesley College President Joins Abiomed Board of Directors

Paula A. Johnson, M.D., also was a professor of medicine at Harvard Medical School.
Business Wire 06.28.21
COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028

Most lucrative growth to occur in Asia Pacific region.
Polaris Market Research 06.28.21
Surgical

Medtronic’s Hugo Robotic Surgery System Makes Clinical Debut

The robotic prostatectomy marked the start of the Hugo RAS System global patient registry.
PR Newswire 06.23.21
PPD, Science 37 Partner to Advance Decentralized Clinical Trials

Approach enables PPD to deploy studies utilizing Science 37's SaaS platform.
PPD 06.23.21
Canada Approves Drug-Releasing Contact Lens for Eye Allergies

Daily disposable lens corrects vision and provides relief to patients suffering from allergic conjunctivitis.
PR Newswire 06.23.21
Glytec Raises $21 Million for R&D, Product Innovation

Glytec’s eGlycemic Management System is proven to reduce low blood sugar by 99.8 percent and 30-day readmissions by 36-68 percent.
Business Wire 06.23.21
Diagnostics

DARPA Enlists University to Develop AI for Portable Ultrasound

Research team will put expert knowledge at the fingertips of frontline medics.
Carnegie Mellon University 06.22.21
Abbott Engages in STEM Internships for College Credit

First-of-its-kind college credit opportunity provides model other companies can follow to give students a head start on earning STEM degrees.
PR Newswire 06.22.21
Avania Purchases IMARC

Acquisition of the medical device CRO fuels rapid global expansion and growth.
Business Wire 06.22.21
Summit Partners Invests in Veranex

Investment will form a concept-to-commercialization medtech services company.
Veranex 06.21.21
Baxter Receives Grant to Lead Extracorporeal Blood Purification Research

Company will focus on enabling more selective approaches for certain extracorporeal blood purification therapies.
Business Wire 06.18.21
Electronics | Neurological

Brain Scientific to Merge with Piezo Motion

Closing contemplates minimum $5M capital investment for combined company.
GlobeNewswire 06.16.21
QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity

The innovation integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift.
Business Wire 06.15.21
Feinstein Institutes Scientists Develop Long-Term Vagus Nerve Implant

Research could help advance the field of bioelectric medicine.
Business Wire 06.11.21
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
Neurological

FDA Approves Medtronic's SenSight Directional Lead System for DBS

Directional lead system enables precision, personalization, and enhanced patient comfort.
Sam Brusco, Associate Editor 06.07.21
Global Diabetes Care Devices Market to Garner $39.4B by 2027

The increasing geriatric population is forecast to drive market growth over the next six years.
Michael Barbella, Managing Editor 06.07.21
CeQur Raises $115 Million Series C5 Financing

Money will support the commercialization and scale-up of automated manufacturing for the firm's Simplicity wearable insulin delivery device.
Michael Barbella, Managing Editor 06.04.21
Cardiovascular | Software & IT

GE Healthcare, ACC Team Up to Advance AI in Cardiac Care

Collaboration will start tackling overwhelming challenges related to AFib management.
Sam Brusco, Associate Editor 06.03.21
Cardiovascular | Patient Monitoring

FDA OKs Edwards' Acumen IQ Cuff Hypotension Prediction Index Software

Uses machine learning to alert clinicians of likelihood a patient is trending toward hypotension.
Sam Brusco, Associate Editor 06.02.21
Cardiovascular

Abiomed Buys preCARDIA, a Heart Failure Tech Firm

preCARDIA system treats acute decompensated heart failure.
Sam Brusco, Associate Editor 06.01.21
Memic Innovative Surgery Raises $96 Million

Funding will primarily support commercialization of the Hominis surgical robot in the United States.
Michael Barbella, Managing Editor 06.01.21
Contract Manufacturing

Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.
Dale Thompson, Staff Writer, MasterControl 05.27.21
Digital Health

Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology

Combination of Philips’ digital pathology solutions and Ibex’s AI-powered Galen platform has improved reporting efficiency by 27 percent.
Michael Barbella, Managing Editor 05.27.21
Digital Health

Philips, UCSF Team Up to Enhance Digital Patient Experience

UCSF will use Philips HealthSuite to oversee development of new technologies.
Sam Brusco, Associate Editor 05.27.21
Element Global Medical Device Capabilities

...
Hologic Launches Project Health Equality

Aims to address the barriers that prevent Black and Hispanic women in the U.S. from receiving the same quality health care as white women.
Charles Sternberg, Assistant Editor 05.17.21
Neurological

Rice Researchers Seek to Create an Implant That Controls the Body’s Circadian Clock

Could halve the time it takes to recover from jet lag and similar disruptions to the body's sleep/wake cycles.
Charles Sternberg, Assistant Editor 05.14.21
Contract Manufacturing

Empowering Connected Medtech Manufacturing Workers

With a worker shortage on the horizon and lessons learned from the pandemic, connected workers could help ease the challenges ahead.
Louis Columbus, Enterprise Software Strategist, DELMIAWORKS 05.13.21
Neurological

Researchers Develop Noninvasive Method for Measuring Brain Blood Flow with Light

Promises to be cheaper than existing technology and could be used for assessing brain injuries or in neuroscience research.
Charles Sternberg, Assistant Editor 05.13.21
J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval

First and only FDA-approved orthokeratology contact lens for myopia management, according to company.
Sam Brusco, Associate Editor 05.12.21
Materials

Swedish Researchers Develop Material That Prevents Infections in Wounds

New hydrogel works against all types of bacteria, including antibiotic-resistant ones.
Charles Sternberg, Assistant Editor 05.12.21
RenovaCare Appoints Interim President and CEO

Kaiyo Nedd, a practicing medical doctor in Canada, will lead the company until a replacement is found.
Michael Barbella, Managing Editor 05.10.21
Diagnostics

Medivolve & Marvel Diagnostics Complete First Stage Clinical Testing of BlowFISH

The technology has entered the next phase toward applying for an EUA from the FDA to test for the COVID-19 virus.
Charles Sternberg, Assistant Editor 05.06.21
Chronic Disease | Diagnostics

GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.
Sam Brusco, Associate Editor 05.06.21
Cardiovascular | Patient Monitoring

Abbott Begins Trial for Patients with Simultaneous AFib and Heart Failure

Will use cardiac ablation and sensors to monitor pulmonary artery pressure and abnormal heartbeats.
Sam Brusco, Associate Editor 05.06.21
QIAGEN Granted EUA for its 4-Plex COVID-19 Test

The assay can detect and differentiate influenzas A and B, respiratory syncytial virus (RSV), and COVID-19 infections within 80 minutes.
Michael Barbella, Managing Editor 05.06.21
FDA Approves Helius Medical's Stimulator Device for Gait Improvement

The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.
Michael Barbella, Managing Editor 05.06.21
PolyVascular Awarded $2 Million Grant to Study Pediatric Heart Valve

Company hires Will Clifton as COO to manage the path to human trials in the United States.
Michael Barbella, Managing Editor 05.06.21
Surgical

FDA Clears XPERIENCE No Rinse Antimicrobial Solution

The solution defends against germs for hours and can used in virtually every open surgery case.
Michael Barbella, Managing Editor 05.04.21
Preparing for the EU’s MDR

As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.
Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21
Five Tips to Protect IP While Working with a Freelancer

Freelancers provide various benefits, but you need to be able to know how to ensure you have a degree of trust with them.
Ramya Sriram, Digital Content Manager, Kolabtree 04.29.21
Materials

The Plastics Problem—Infection Control vs. Medical Equipment

Due to harsh chemicals, medical device manufacturers need a solution to the problems caused by regular cleaning of healthcare equipment.
Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21
Diagnostics | R&D & Design

5 Guidelines for Productizing an Optically Based Medical Device

Pitfalls most relevant to optical medical devices, but many are applicable to medical devices without optics.
Brian King, Principal Optical Systems Engineer, StarFish Medical 04.29.21
Neurological

FDA OKs BrainsWay's Three-Minute Theta Burst Protocol for Depression

Shorter protocol further expands access to care.
Sam Brusco, Associate Editor 04.27.21
Neurological

Medtronic's TNM Implant Study for Bladder Incontinence Gets FDA Nod

Implantable tibial neuromodulation (TNM) therapy will be evaluated for symptom relief.
Sam Brusco, Associate Editor 04.27.21
Neurological

LivaNova, Verily Begin Difficult-to-Treat Depression Study

Verily research tools will evaluate real-world VNS Therapy effectiveness as adjunctive difficult-to-treat depression treatment.
Sam Brusco, Associate Editor 04.27.21
Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry

Prevalence of critical congenital heart disease in the Sri Lankan study was 2.02 per 1,000 live births.
Michael Barbella, Managing Editor 04.22.21
Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

Projects address infant feeding development, neonatal jaundice, pediatric dysphagia, unplanned extubations, and adrenal crisis.
Michael Barbella, Managing Editor 04.19.21
Iterative Scopes Announces IBD-Focused Scientific Advisory Board

The governing body also will include experts in artificial intelligence.
Michael Barbella, Managing Editor 04.16.21
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
Thermo Fisher Scientific to Acquire PPD for $17.4 Billion

The deal establishes Thermo Fisher as a global leader in the high-growth clinical research services industry.
Michael Barbella, Managing Editor 04.15.21
Portable Medical Devices Market to Reach $100 Billion by 2027

Sector to grow 8.5 percent annually over the next six years, driven by an increased awareness of overall health and fitness.
Michael Barbella, Managing Editor 04.15.21
Diagnostics

DiaSorin to Buy Luminex for $1.8B

Provides access to proven Luminex multiplexing technology and molecular testing solutions.
Sam Brusco, Associate Editor 04.13.21
Cardiovascular

Endologix Acquires PQ Bypass

Gains proprietary Detour platform for percutaneous femoral-popliteal bypass.
Sam Brusco, Associate Editor 04.13.21
Cardiovascular

Elixir Medical Begins Study of Metallic Implant for CAD Treatment

Product is designed to adapt to vessel physiology.
Michael Barbella, Managing Editor 04.13.21
Glooko Raises $30 Million in Series D Funding

Investment follows most successful year in company history.
Michael Barbella, Managing Editor 04.13.21
CMS Establishes New Payment for Pelvalon’s Eclipse System

Enables women access to a life-changing therapy for loss of bowel control.
Charles Sternberg, Assistant Editor 04.09.21
Cardiovascular

Digging into the Cardiac Arrhythmia Monitoring Device Market

The overall market is set to reach an annual valuation of $9 billion by 2026.
Saloni Walimbe, Research Content Developer, Global Market Insights 04.08.21
Surgical

Bausch + Lomb's ClearVisc Dispersive Ophthalmic Viscosurgical Device Approved

Offers corneal protection and visibility during ophthalmic surgery.
Sam Brusco, Associate Editor 04.07.21
J&J Vision, Menicon Begin Myopia Contact Lens Making Partnership

The firms aim to bring forward a portfolio of products and services to manage myopia progression in children.
Sam Brusco, Associate Editor 04.07.21
Grant Issued for Development of 3D-Printed Resorbable Medical Implants

BellaSeno and Fraunhofer Institute for Production Technology are partnering on the innovation.
Michael Barbella, Managing Editor 04.05.21
Philips Survey Reveals COVID-19’s Negative Impact on Sleep Quality, CPAP Use

Seventy percent of people surveyed have experienced one or more new sleep challenges since the start of the pandemic, data show.
Michael Barbella, Managing Editor 04.05.21
Samsara Vision, Medevise Consulting Forge European Partnership

Pair will collaborate to advance clinical research, coordinate reimbursement, and drive sales, marketing, and customer relationships.
Michael Barbella, Managing Editor 04.05.21
Second Sight Aborts Business Combination with Pixium Vision

Pixium said it would take all necessary means—including legal measures—to claim compensation.
Sam Brusco, Associate Editor 04.05.21
Cardiovascular | Surgical

Home Is Where the Heart (Valve) Is

Artificial heart valve makers reached a number of milestones despite the pandemic’s global squeeze.
Sam Brusco, Associate Editor 04.01.21
Chronic Disease | Digital Health | Patient Monitoring

CGM: Digital Health Meets a Very Large Opportunity

Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.
Maria Shepherd, President and Founder, Medi-Vantage 04.01.21
Surgical

Ethicon Launches Echelon+ Stapler

Increases staple line security and reduces complications in surgery.
Charles Sternberg, Assistant Editor 04.01.21
Bassetti Acquires 3DTRUST

The deal expands Bassetti’s TEEXMA for additive manufacturing solution suite.
Michael Barbella, Managing Editor 03.31.21
Ultrasound Stimulation Can Reduce Obesity, Research Indicates

New study is based on the discovery that ultrasound can be used to perform peripheral nerve modulation as a new form of bioelectronic medicine.
Michael Barbella, Managing Editor 03.29.21
Harnessing Critical Health Data With Wearable Technology

Optical biosensors could open new doors for front-end patient care.
Robert Newberry and Matthew Rodencal, Sanmina Corporation 03.26.21
Masimo's Rad-G With Temperature Earns CE Mark

Rad-G can be converted from a handheld spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors.
Michael Barbella, Managing Editor 03.24.21
J&J Executive, CNN On-Air Commentator Appointed to Glaukos Board

With latest additions, the governing body now consists of nine directors.
Michael Barbella, Managing Editor 03.24.21
Urgotech Unveils Results from Clinical Study of Urgonight

Helped users gain more sleep each night.
Charles Sternberg, Assistant Editor 03.18.21
Olympic Bobsledder Named New Board Chairman at PathogenX

World Cup medalist has spent half his sales and management career in the medical device and healthcare technology sector.
Michael Barbella, Managing Editor 03.18.21
SIA Enrolls First Patient in Study of its Surgical Mesh for Breast Reconstruction

The product is made from a biocompatible synthetic material to provide mechanical support and scaffolding.
Michael Barbella, Managing Editor 03.17.21
Testing

NAMSA Appoints New CEO, Board Chairman

Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.
Sam Brusco, Associate Editor 03.15.21
Four Ways Remote Freelance Experts Can Help Medtech

Changes in the regulatory landscape and working-from-home scenarios reduce the degree of change when working with remote consultants.
Ramya Sriram, Digital Content Manager, Kolabtree 03.15.21
Testing

Sotera Health Acquires BioScience Laboratories

Strengthens Sotera Health’s antimicrobial and antiviral lab testing capabilities.
Charles Sternberg, Assistant Editor 03.11.21
Europe Marks First CellFX Procedures

The cellular-focused CellFX System is designed to clear common benign skin lesions.
Michael Barbella, Managing Editor 03.11.21
Digital Health | Software & IT

3M Bags Contract from Michigan Medicine for AI-Powered Clinician, Revenue Cycle Tech

Solutions aim to help Michigan Medicine reduce physician stress, bolster thorough clinical documentation.
Sam Brusco, Associate Editor 03.10.21
Neurological | Patient Monitoring

FDA OKs Brain Scientific's Next-Gen NeuroCap EEG Headset

NeuroCap's advanced EEG electrode array obtains rapid EEGs in routine clinical and research settings.
Sam Brusco, Associate Editor 03.10.21
Digital Health

Market for Virtual Critical Care Solutions to Nearly Double

With critical care becoming increasingly data intensive, companies will need to collaborate with cloud solutions providers.
Michael Barbella, Managing Editor 03.09.21
Virginia School of Medicine Dean Appointed to Baxter's Board

Former Owens-Illinois CEO to serve as lead independent director.
Michael Barbella, Managing Editor 03.09.21
Bexson Biomedical Appoints Sheldon Moberg as VP, Drug Delivery

Moberg will lead the development of Bexson’s drug delivery technologies, starting with a wearable infusion device for its BB106 therapy.
Charles Sternberg, Assistant Editor 03.08.21
FDA Making Progress With Technology and Data Action Plans

There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.
Alan Rencher, Vice President, Engineering, MasterControl 03.04.21
Cardiovascular

Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

Will evaluate PulseSelect's pulsed electrical fields to interrupt irregular heart rhythms.
Sam Brusco, Associate Editor 03.04.21
NAMSA Acquires American Preclinical Services

Enhances its preclinical solutions with a broader range of laboratory models and analysis tools.
Charles Sternberg, Assistant Editor 03.02.21
Surgical

Memic Receives FDA Marketing Authorization for Hominis

Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.
Charles Sternberg, Assistant Editor 03.02.21
Surgical

Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz

Medi-Tate's iTind nitinol implant supports lower urinary tract symptom relief due to benign prostatic hyperplasia.
Sam Brusco, Associate Editor 03.02.21
FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System

The Cooral System was CE marked in June 2020 as an invasive medical device.
Michael Barbella, Managing Editor 03.02.21
Chronic Disease

January AI Raises $8.8 Million in New Funding

New technology can predict users’ glycemic response to over 16 million foods in its proprietary atlas.
Charles Sternberg, Assistant Editor 02.26.21
FDA Clears Ava Fertility Tracking Wearable Device

The wearable is clinically proven as effective as LH tests in predicting ovulation—and with more fertile days detected.
Michael Barbella, Managing Editor 02.26.21
FDA Approves Daytime Treatment for Sleep Apnea and Snoring

Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.
Michael Barbella, Managing Editor 02.23.21
Diagnostics

Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.
Charles Sternberg, Assistant Editor 02.22.21
Flywheel Secures $15 Million in Series B Funding

The funding will allow the company to deepen its presence in the life sciences and AI markets.
Michael Barbella, Managing Editor 02.19.21
RDS Completes 3 Million Euros Seed Funding Round

Funding will be used for the first clinical trials of the MultiSense Connected Sensor Patch.
Michael Barbella, Managing Editor 02.18.21
Cardiovascular

Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

Technology approved to treat calcified coronary plaque.
Charles Sternberg, Assistant Editor 02.17.21
FDA Appoints its First Cybersecurity Director

University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.
Michael Barbella, Managing Editor 02.17.21
Diagnostics

Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

The assay is currently available in Europe.
Michael Barbella, Managing Editor 02.16.21
Diagnostics | Digital Health | Software & IT

Pioneering AI Solutions to Reinforce Healthcare Services

Can AI live up to its hype in the healthcare landscape?
Sunil Jha, Senior Research Content Developer, Global Market Insights 02.12.21
Refurbished Medical Imaging Equipment Market to be Worth $21.14 Billion By 2027

The market's growth will be driven primarily by increasing demand for cost-effective medical imaging equipment.
Michael Barbella, Managing Editor 02.10.21
Digital Health

Evolving Trends in the Medical and Orthopedic Devices Industry

There are a number of areas worth keeping an eye on within medtech in 2021 and beyond.
Jacqueline Trovato, Healthcare/Legal Writer 02.09.21
Diagnostics

ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

System can be used for COVID-19, Influenza A & B, and other viruses.
Charles Sternberg, Assistant Editor 02.09.21
Diagnostics

Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027

A desire to provide rapid disease treatments is driving the market's growth.
Michael Barbella, Managing Editor 02.09.21
Machine Learning Tool Predicts Respiratory Failure in COVID-19 Patients

To develop the ML clinical models, scientists used measurements commonly recorded in the ER, such as vitals and labs, as well as demographics.
Michael Barbella, Managing Editor 02.08.21
Cardiovascular

FDA Clears Wearable Electrocardiogram Sensor

The product offers extended ambulatory ECG recording up to three weeks.
Michael Barbella, Managing Editor 02.08.21
Kardium Receives $115 Million in New Financing for Afib Treatment

Money will be used to accelerate commercial growth of the Globe System across Europe.
Michael Barbella, Managing Editor 02.04.21
Hemostasis and Tissue Sealing Agents Market to Swell to $6.6 Billion by 2026

An increase in demand globally for MI surgeries and the rise in geriatric patients with chronic conditions are driving the growth.
Michael Barbella, Managing Editor 02.04.21
Perspectives on Post-Pandemic: Consider the IT Infrastructure

Maria Shepherd of Medi-Vantage reminds medtech developers to be aware of the strains on the current IT system at most hospitals.
Maria Shepherd, President, Medi-Vantage 02.03.21
A Blueprint for Reducing Medtech Industry's Carbon Footprint

Global warming impact of “single-use” medical devices can be halved by using reprocessed products.
Michael Barbella, Managing Editor 02.03.21
Pulse Biosciences Granted CE Mark Approval for CellFX System

Product delivers nano-pulse stimulation technology to clear hard-to-treat benign skin lesions.
Michael Barbella, Managing Editor 02.03.21
Cardiovascular | Surgical

Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

There were no incidences of structural valve deterioration at the five-year mark.
Sam Brusco, Associate Editor 02.01.21
New Biomaterials Can be ‘Fine-Tuned’ for Medical Applications

Animal testing has confirmed the material's safety and biocompatibility.
Michael Barbella, Managing Editor 02.01.21
Patient Monitoring

Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech

EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.
Sam Brusco, Associate Editor 02.01.21
Cardiovascular

Medtronic's DiamondTemp Ablation System Gains FDA Approval

Treats patients with recurrent, symptomatic paroxysmal atrial fibrillation unresponsive to drug therapy.
Sam Brusco, Associate Editor 01.29.21
Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions

The new members represent a cross-section of industry, government, research institutions, and non-profit agencies.
Michael Barbella, Managing Editor 01.29.21
Olympus Agrees to Acquire Quest Photonic Devices

Bolsters its surgical endoscopy capabilities with new imaging systems.
Charles Sternberg, Assistant Editor 01.28.21
Diagnostics

Spectrum Solutions Collaborates with UCLA School of Dentistry

Commences study on using saliva in early lung cancer detection and analysis.
Charles Sternberg, Assistant Editor 01.27.21
Cardiovascular | Surgical

Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

UBC Okanagan research could transform the current gold standard for heart valves.
Sam Brusco, Associate Editor 01.27.21
Molding

Material Science for Micromolding—A Medtech Makers Q&A

Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.
MedAcuity, Fathom Partner on Human Factors Engineering Services

Focused on facilitating safe and effective use of medical devices, HFE is a critical aspect of product development.
Michael Barbella, Managing Editor 01.25.21
Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

The daily disposable, silicone hydrogel contact lens for astigmatism will roll out concurrently worldwide beginning in February.
Sam Brusco, Associate Editor 01.21.21
Materials

Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial

Enables both the rate at which it degrades in the body and its mechanical properties to be controlled independently.
University of Birmingham 01.20.21
Neurological

Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.
Business Wire 01.14.21
Patient Monitoring

Unique Contact Lens Sensor System & Manufacturing Process Developed

New multifunctional lens can provide diversified signals from eyes.
Surrey University 01.12.21
Researchers Receive Funding to Develop Smart Vaccine Device

New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.
Swansea University 01.12.21
Patient Monitoring

CES News: Philips Highlights Healthcare at Home

Participates in the first-ever all-digital CES 2021.
Royal Philips 01.11.21
Diagnostics

ForaCare Suisse AG Launches COVID-19 Antigen Rapid Test

Provides fast, accurate, and easy-to-interpret test results.
PRNewswire 01.11.21
Sera Prognostics Partners with Anthem and HealthCore

Aims to improve outcomes for preterm babies.
Globe Newswire 01.08.21
New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System

The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.
B3C newswire 01.08.21
Diagnostics

Quantitative Transmission Ultrasound Outperforms Mammography

QT Imaging completes first-in-human study of transmission ultrasound as a new imaging technology for breast health screening.
PRNewswire 01.07.21
Medtech Veteran Joins VivaLNK Board

Experienced healthcare industry professional to advise VivaLNK’s executive team and assist in its growth in digital health.
VivaLNK 01.05.21
Diagnostics

Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval

Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.
Mologic Ltd 01.05.21
Cardiovascular

Edwards Treats First Patient in Restore Clinical Trial

Evaluates minimally invasive device for mitral valve disease.
Edwards Lifesciences Corp. 12.21.20
Philips Buys BioTelemetry for $2.8 Billion

With 2019 sales of $439 million, BioTelemetry annually monitors over 1 million cardiac patients remotely.
Royal Philips 12.18.20
4D Biomaterials Awarded Funding for 3D Tissue Scaffolds

The company's new polycarbonate-based resins can be formed into materials that have good shape memory, and tuneable mechanical and chemical properties.
4D Biomaterials 12.16.20
Cardiovascular | Diagnostics

Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.
Business Wire 12.16.20
Surgical

Olympus Adds 3D, IR, Novel Light Tech to MIS Imaging Platform

Expanded VISERA ELITE II surgical imaging capabilities may help reduce costs, improve efficiency.
Olympus
Cardiovascular

Abbott Launches OCT Virtual Reality Training for Cardiologists

VR training improved cath lab staff learning engagement by 45 percent, knowledge retention by 72 percent.
Abbott Laboratories 12.09.20
BellaSeno Establishes High-Throughput Additive Manufacturing Facility for Resorbable Implants

Manufacturing at the facility will be based on the no-touch approach to significantly improve the safety and sterility of medical implants.
BellaSeno GmbH 12.09.20
Chronic Disease

Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine

The Carpediem system is designed to treat patients requiring renal replacement therapy weighing between 2.5 and 10 kilograms (5.5 to 22 pounds).
PR Newswire 12.08.20
Survey Finds On-Site Inspections Plummeted by 93 Percent

Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.
Greenlight Guru 12.08.20
MedAcuity Partners With Loft to Support the Full MedTech Product Development Lifecycle

Companies will focus on designing hardware and software that acts in harmony in a single diagnostic or wearable medical device or system.
MedAcuity 12.08.20
Molding

A 'Trial and Error' Approach to Micromolded Parts

The medical industry's stringent requirements makes innovation difficult for injection-molded components.
Michael Barbella, Managing Editor 12.07.20
Chronic Disease

New Research Sheds Light on Potential Glaucoma Treatment

Hydrogels could provide an alternative to drugs or surgery.
Georgia Institute of Technology 12.07.20
Shimmer Research Receives CE Certification for Inertial Measurement Unit Sensor

The wearable sensor is now recognized as a medical device in Europe, capable of providing continuous, medical-grade measurements of a person’s activity.
Shimmer Research 12.07.20
Digital Health

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.
Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20
Cytek Biosciences Completes Series D Funding Round

The investment will be used to expand the company’s global infrastructure.
Globe Newswire 12.03.20
Cardiovascular

LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M

Enables company to sharpen its focus within primary platforms, neuromodulation and cardiovascular.
Business Wire 12.03.20
Software & IT

Leveraging Virtual Technology for Customer Service and Support

VR/AR solutions enable contactless interactions with customers to address a variety of needs.
Dijam Panigrahi, Co-Founder and COO, Grid Raster Inc. 12.02.20
Foxx Life Sciences Appoints SVP of Global Sales and Business Development

Mark Robillard brings industry knowledge and experience in all facets of the life science tools industry.
Foxx Life Sciences 12.01.20
Diagnostics

RSNA News: RADLogics’ AI-Powered COVID-19 Medical Imaging Solutions

The company’s latest algorithm enhancements to help radiologists distinguish between coronavirus and other abnormalities.
RADLogics 11.30.20
Chronic Disease

Increasing Comfort for Chemotherapy Patients

Leveraging a freelance researcher in bringing the Chemo Mouthpiece to market—A case study.
Ramya Sriram, Digital Content Manager, Kolabtree 11.24.20
Software & IT

GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

A necessary and important step when ventilating critically ill COVID-19 patients.
Business Wire 11.23.20
Advanced NanoTherapies Raises $5.3 Million in Seed-Round Financing

Company accelerates development of its nanoparticle-based drug delivery technology platform to treat peripheral artery disease and other applications.
Business Wire 11.23.20
Femtech Firm Launches Two-in-One Medical Device to Help Women With Conception

A $1.5 million seed accelerates manufacturing and shipping; app is updated to incorporate user feedback.
PR Newswire 11.23.20
THE DETROIT FREE PRESS NAMES PTI Engineered Plastics

A WINNER OF THE DETROIT TOP WORKPLACES 2020 AWARD
Diagnostics

GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Buy

Gains Deep Silicon detector technology for photon counting computed tomography (PCCT).
Business Wire 11.20.20
Diagnostics | Patient Monitoring

Digital Radiology Ushering Innovations in the Medical Imaging Market

Radiology is on the cusp of revolution following the soaring popularity of digital radiography.
Sunil Jha, Research Content Developer, Global Market Insights 11.17.20
Cardiovascular

First Patients Treated With Pulsed Electric Field Cardiac Ablation System

Galaxy Medical's Centauri System is designed as an open energy platform with proprietary interface hardware and waveform control algorithms.
PR Newswire 11.17.20
Foldax Strengthens its Scientific and Medical Advisory Boards

Company adds two new members to each of the governing bodies.
Business Wire 11.17.20
Cardiovascular | Surgical

Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

Voluntary recall is related solely to the delivery system.
PR Newswire 11.17.20
Chronic Disease

Wrighting the MiMedx Ship: An Exclusive Interview

In this interview with the firm’s new CEO, MPO discovers what’s been done to turn the page on the company’s troubled past.
Sean Fenske, Editor-in-Chief 11.13.20
Patient Monitoring

Implantable Sensor Could Measure Bodily Functions, Then Safely Biodegrade

Can monitor various forms of nitric oxide and nitrogen dioxide gas in the body.
Penn State 11.12.20
Neurological

'Smart Wrap' Implant May Help Improve Bladder Control

Delivers light to the bladder for optogenetic neuromodulation of underactive bladders.
Penn State 11.12.20
3D/Additive Manufacturing | Surgical

Biodegradable 3D Printed Stents Treat Esophageal Inflammation

Stent with esophageal-derived bioink helps treat radiation esophagitis.
POSTECH 11.12.20
Surgical

OnLume Surgical Awarded $2 Million Grant to Develop Fluorescence-Guided Surgery Device

The company's FGS imaging technology illuminates critical anatomy in real-time during surgery to optimize precision.
Business Wire 11.12.20
Digital Health

Telehealth Patient Satisfaction Surges During Pandemic But Barriers to Access Remain

Study finds that 46 percent of patients chose telehealth services for safety reasons.
Business Wire 11.11.20
Alucent Biomedical Closes $35 Million Series B Financing Round

Funding will support clinical trials to evaluate the company’s treatment for peripheral artery disease.
Business Wire 11.11.20
University Develops AI Algorithm to Analyze Chest X-Rays for COVID-19

Academic team created algorithm using 100,000 X-rays of patients who did not have COVID-19 and 18,000 X-rays of patients who did.
Globe Newswire 11.10.20
Study: NEUWAVE System With Ablation Confirmation Software Leads to Improved Outcomes

Data showed the MI technology helps improve precision and accuracy in ablation procedures, which is critical to achieving technical success.
Ethicon 11.10.20
Patient Monitoring

Prevounce Health Launches Remote Patient Monitoring Module

The module combines digital spirometry, smart nebulizers, and pulse oximetry.
PR Newswire 11.10.20
Contract Manufacturing

Freudenberg Medical Completes New Manufacturing Operation

Establishes new facility in Beverly, Massachusetts.
Freudenberg Medical 11.10.20
Harvard Professor Joins ExThera Medical Board

New member is recognized as a leading authority on competitive strategy, the competitiveness and economic development of nations and regions.
Business Wire 11.05.20
Chronic Disease

Pharmaceutical Focus: A Look at Combination Products

Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.
Mark Crawford, Contributing Writer 11.04.20
The Lost Year: 2020 Year in Review

Lessons learned from the global coronavirus pandemic.
Michael Barbella, Managing Editor 11.04.20
Cardiovascular

The Heart of the Matter: Trends in Cardiology

Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.
Maria Shepherd, President and Founder, Medi-Vantage 11.04.20
Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.
Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 11.04.20
Company Developing a COVID-19 Severity Risk Test for U.S. Government

The technology, known as host-response diagnostics, rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm.
Inflammatix 11.04.20
Babson Diagnostics Closes $13.7 Million Series A Financing

Money will be used to democratize blood testing.
Business Wire 11.03.20
Cardiovascular

Robocath Creates Joint Venture with MircroPort

Enables the commercialization of Robocath’s R-One platform in China.
Robocath 11.02.20
Diagnostics

Imec Developing Five Minute COVID Test

Approach will use virus particles in exhaled breath to identify positive cases and confirm contagion risk.
Imec 10.30.20
Digital Health

How AI Is Improving Predictive Analytics in Healthcare

Predictive analytics and artificial intelligence can enable a more efficient pathway to a better treatment protocol.
Thomas Lanigan, Technical Writer 10.30.20
RapidAI Announces $25 Million in Series B Funding

Company to use the funds to expand AI-enhanced cerebrovascular imaging worldwide.
Business Wire 10.26.20
Cardiovascular

Prytime Medical Launches New ER-REBOA PLUS Catheter

Product was developed to help doctors preserve their clinical options for optimal care and best outcomes.
Business Wire 10.26.20
Supply Chain Study Offers Insights on Medtech Recovery

Concerns remain about data accuracy, distribution, surge-related delays, and shortages.
Supplyframe 10.22.20
Chronic Disease

FDA Grants Breakthrough Device Designation to Cala Trio

Aims to treat action tremors in the hands of adults with Parkinson's disease.
Cala Health 10.22.20
BD Makes Executive Leadership Appointments

Names Patrick Kaltenbach as executive vice president and chief technology officer.
BD 10.22.20
Diagnostics

SimonMed Imaging, Philips Partner to Deploy New Dx Imaging Tech

SimonMed will introduce Philips’ state-of-the-art 3T MR services to help improve patient care.
GlobeNewswire 10.22.20
Heated Face Mask Filters and Inactivates Coronaviruses

Includes heated copper mesh powered by a battery and surrounded by insulating neoprene.
Anne Trafton, MIT News Office 10.22.20
First Patients Treated in Trial for Liver and Pancreas Sealant Patch

The patch is optimized to significantly reduce fluid leakage during the critical healing period after hepato-pancreato-biliary procedures.
B3C Newswire 10.22.20
SETi, Seoul Viosys Begin Mass Production of Coronavirus Sterilization Module

Product sterilizes 99.9 percent of coronavirus in three seconds.
Sensor Electronic Technology Inc. 10.22.20
Global Ophthalmoscopes Market to Surpass $289.4 Million by 2027

Increasing product launches is expected to support growth of the market.
Coherent Market Insights 10.20.20
Diagnostics

New Tech Diagnoses Sickle Cell Disease in Record Time

Only requires a power source, a microscope and a camera.
University of Colorado Boulder 10.19.20
Diagnostics

Examining the COVID-19 Detection Kits Market

RT-PCR has become second to none in the global healthcare systems for testing COVID-19.
Sunil Jha, Research Content Developer, Global Market Insights 10.16.20
Patient Monitoring

Ingestible Capsule May Help Demystify the Gut-Brain Axis

A platform that can monitor and model gut microbiome serotonin activity.
University of Maryland 10.16.20
Diagnostics

All-Terrain Microrobot Flips Through a Live Colon

The microrobots could act as diagnostic tools in addition to drug delivery vehicles.
Purdue University
Cardiovascular | Surgical

ACURATE Neo TAVR Valve Fails to Demonstrate Non-Inferiority

Results from the SCOPE II trial reported at TCT Connect and published simultaneously in Circulation.
Cardiovascular Research Foundation (CRF) 10.16.20
Using Revenue-Based Financing to Grow in the Pandemic

One revenue-based funding investor shares real-world examples of firms that gained access to cash without giving up a piece of the company.
Wayne Cantwell, Co-Founder and Managing Director, Decathlon Capital Partners 10.14.20
Miracor Medical Raises 24 Million Euros

Funds will be used for clinical studies and initiation of PiCSO commercialization.
Business Wire 10.14.20
Cutera Launches truSculpt flex in Canada

Product treats up to eight areas simultaneously, covering the largest area in the body sculpting industry.
Business Wire 10.14.20
Diagnostics

New Blood Test Predicts Which COVID-19 Patients Develop Serious Infection

Measures levels of pro-inflammatory and anti-inflammatory molecules.
PR Newswire 10.14.20
ArchiMed Acquires Majority Interest in NAMSA

Investment to accelerate NAMSA’s global growth and strategic vision.
Business Wire 10.14.20
Cardiovascular | Surgical

Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve

Also begins feasibility study of Evolut in moderate and asymptomatic aortic stenosis patients.
PR Newswire 10.14.20
Vielight Launches COVID-19 Clinical Trial With Home-Use Device

Study will evaluate whether special light therapy is an effective coronavirus treatment.
Globe Newswire 10.14.20
Neurological

FDA OKs CEFALY DUAL Migraine Treatment for Use Without Prescription

First external Trigeminal nerve stimulator for the treatment of migraine headaches.
PR Newswire 10.13.20
7 Steps to Create Your Own Medical Device Marketing Plan

A successful strategy will result in increased leads while saving time and money.
Robert Jordan, Media Relations Manager, InfoClutch Inc. 10.09.20
ERT and Science 37 Partner to Deliver High-Quality Data During Virtual Trials

Alliance enables trial sponsors to improve imaging, respiratory, and cardiac safety data quality while reducing patient burden and risk.
ERT 10.08.20
Diagnostics

Abbott Shares ID NOW COVID-19 Interim Clinical Study Results

ID NOW performance of 95 percent sensitivity, 97.9 percent specificity within seven days of symptom onset.
Abbott Laboratories 10.07.20
St. Jude Children's Research Hospital Executive Joins Cardiovascular Systems Board

New member is the third independent director to join the board.
Business Wire 10.07.20
Chronic Disease

FDA Commissioner: Safe COVID-19 Vaccines Will Be Approved by ‘Career Scientists,’ Not Politicians

Dr. Hahn speaks out at The Virtual MedTech Conference.
AdvaMed 10.05.20
Digital Health

Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials

Medidata Detect identifies known and unknown risks, and triggers corrective actions.
Business Wire 10.05.20
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
Contract Manufacturing | Electronics

Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

But many companies are hesitant to start new development projects while the coronavirus is still rampant.
Michael Barbella, Managing Editor 10.05.20
Digital Health

AdvaMed Proposes Modernized CMS Policies for Digital Health

AdvaMed CEO Whitaker calls on CMS to “eliminate bureaucratic obstacles” to digital health.
AdvaMed 10.02.20
TransEnterix Taps Former Profound Medical Executive for CFO Role

In addition to corporate leadership roles, the new CFO spent time as an investment banker and sell-side equity research analyst.
Business Wire 10.02.20
National Pediatric Medical Device Competition Announces Six Winners

Winning devices in virtual pitch event on track to advance pediatric cardiovascular, NICU, and orthopedic and spine device innovations.
National Capital Consortium for Pediatric Device Innovation 10.01.20
Molding

Little Big Parts: Micromolding Under the Microscope

Minimally invasive surgery, device miniaturization, and age-related conditions are increasingly driving the need for micromolded medtech components.
Michael Barbella, Managing Editor 10.01.20
Abbott

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07.21.20