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Monarch eTNS System Approved by Singapore Regulators
The Monarch is the first-ever medical device to receive HSA approval as a treatment for pediatric ADHD.Michael Barbella, Managing Editor 12.06.23
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Electronics
Omini Electrochemical Based Sensor for Blood Testing Earns EU Patent Approval
Builds a strong Intellectual Property portfolio for the company.Charles Sternberg, Associate Editor 12.06.23
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Phillip G. Febbo Appointed Chief Scientific Officer/Chief Medical Officer at Veracyte
Febbo has more than 25 years of experience across academia and industry.Michael Barbella, Managing Editor 11.30.23
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PPG, Flō-Optics Partner to Provide First Digitally Applied Optical Coatings
3D printing featuring PPG HI-GARD lens coatings provides durability and scratch resistance.Michael Barbella, Managing Editor 11.29.23
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Covalon Technologies Appoints Interim CEO
Board Chairman Amir Boloor stepping in for Brian Pedlar as the company searches for a permanent replacement.Michael Barbella, Managing Editor 11.28.23
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Neptune Medical Appoints Fred Moll as Chairman of the Board
Influential figure and entrepreneur in medtech to help grow the company.Rachel Klemovitch, Assistant Editor 11.21.23
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Cardiovascular
Medtronic's Pulsed Field, Cryoablation Tech Obtain EU Approval
PulseSelect pulsed field ablation and cryoablation tech received CE mark clearance.Sam Brusco, Associate Editor 11.20.23
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Cardiovascular
FDA Approves Pivotal Study of Orchestra Biomed's BackBeat CNT
Company has a strategic collaboration with Medtronic to develop and commercialize Atrioventricular Interval Modulation (AVIM) therapy.Michael Barbella, Managing Editor 11.15.23
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Surgical
J&J's Ethicon Earns EU Approval for Ethizia Hemostatic Sealing Patch
The company said in 80% of clinical trial patients studied, Ethizia stopped bleeding in 30 seconds.Sam Brusco, Associate Editor 11.15.23
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Surgical
Chinese Regulators Approve J&J MedTech's MONARCH Platform for Bronchoscopy
The MONARCH Platform is the first MI, robotic-assisted technology approved for bronchoscopy in a country with a significant lung cancer burden.Michael Barbella, Managing Editor 11.14.23
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Inogen Appoints Kevin Smith as CEO
Smith was most recently CEO of Sirtex Medical, a maker of interventional treatment products.Sam Brusco, Associate Editor 11.13.23
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Cordis Appoints Scott Drake as New Leader
He succeeds Shar Martin, who stepped down as CEO.Sam Brusco, Associate Editor 11.06.23
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Chinese Regulators Approve World's Only Adjustable Thrombectomy Device
Rapid Medical's TIGERTRIEVER is designed to accelerate clot integration and reduce vessel damage in ischemic stroke.11.01.23
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Chronic Disease | Patient Monitoring
SIBIONICS Wins EU Approval for GS1 CGM
The GS1 continuous glucose monitor features calibration-free, 14 days of continuous glucose monitoring.Sam Brusco, Associate Editor 11.01.23
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Chronic Disease
Insulet's Omnipod 5 iPhone App Wins FDA OK
The app includes a new custom foods feature to save carbohydrate data for favorite foods, snacks, or meals.Sam Brusco, Associate Editor 10.23.23
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FDA Approves Tampon With Helical Design
Agency deems the tampon, which aims to improve comfort and reduce leakage, a medical device.Michael Barbella, Managing Editor 10.23.23
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Cardiovascular | Surgical
Medtronic's Evolut FX TAVI Granted EU Approval
Evolut FX is the latest in the company’s CoreValve/Evolut transcatheter aortic valve implantation platform.Sam Brusco, Associate Editor 10.12.23
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Chronic Disease
FDA Approves Medtronic's SynchroMed III Pain Pump
The upgraded system features a new “refill only” physician workflow.Sam Brusco, Associate Editor 10.10.23
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Cardiovascular
Endotronix Nets IDE Approval for PROACTIVE-HF 2 Study
The study will evaluate the company’s Cordella sensor for pulmonary artery pressure-guided therapy.Sam Brusco 10.09.23
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Cardiovascular
Elixir Medical Submits DynamX to Japan’s PDMA Agency for Regulatory Approval
Novel coronary implant overcomes the limitations of drug-eluting stents and bioresorbable scaffolds.Charles Sternberg, Associate Editor 10.05.23
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Olivier Delporte Appointed CEO of SamanTree Medical
New leader has more than 22 years of experience driving growth and innovation of fast-growing companies across various therapeutic areas.Michael Barbella, Managing Editor 09.29.23
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Cardiovascular
India Regulators Approve BaroPace's PressurePace Clinical Trial
The trial is the first to analyze a real-time closed loop pacemaker regulation system based upon blood pressure input.Michael Barbella, Managing Editor 09.29.23
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Technological Advancement's Speed Is Lapping the Medical Device Industry
This period of explosive growth is challenging the medical device industry to find new ways to adapt, embrace, and pivot.Dawn A. Lissy, President, Empirical 09.25.23
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FDA Approves IDE Use of ExThera Medical's OncoBind Extracorporeal Procedure
The blood filtration procedure removes circulating tumor cells in pancreatic cancer patients.Michael Barbella, Managing Editor 09.19.23
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Digital Health | Patient Monitoring
FDA Clears Natural Cycles Birth Control App for Use with Apple Watch
The integration lets the Natural Cycles app use overnight wrist temperature data from Apple Watch Series 8 and later or Apple Watch Ultra.Sam Brusco, Associate Editor 09.19.23
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Chronic Disease | Digital Health
Abbott, WeightWatchers Release App for Type 2 Diabetes Patients
WeightWatchers members can access glucose data from FreeStyle Libre 2 while being guided by the plan.Sam Brusco, Associate Editor 09.19.23
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FDA Approves Urotronic's BPH Catheter System
The company won FDA approval for Optilume after running a clinical trial that compared the device to a sham treatment in 148 patients.Michael Barbella, Managing Editor 09.18.23
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Mehdi Shishehbor Appointed Chief Medical Officer at Inquis Medical
Company also names serial medtech entrepreneur Bruce Shook to its Board of Directors.Michael Barbella, Managing Editor 09.14.23
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FDA Approves IDE Trial of Verve Medical's Treatment for Uncontrolled Hypertension
Company's Renal Pelvic Denervation System showed a 20.3 mm Hg reduction in blood pressure and a 12-month durability.Michael Barbella, Managing Editor 09.14.23
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Japanese Regulators Approve Cardiovascular Surgical Patch
The new product will be used to treat congenital heart disease patients.Michael Barbella, Managing Editor 09.13.23
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Materials | Molding
What’s Happening with Materials at the Micro Level?—A Medtech Makers Q&A
Find out what medtech developers need to know about the materials being used in the micromolding process.
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William Fletcher Appointed Senior Director at Knipper Health
New hire has more than 41 years of experience in the life sciences industry.Michael Barbella, Managing Editor 09.08.23
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Cardiovascular
FDA Approves Boston Scientific's Latest-Gen WATCHMAN FLX Pro LAAC Device
The device now touts a polymer coating, visualization markers, and a broader size matrix.Sam Brusco, Associate Editor 09.06.23
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Diagnostics
Chinese Regulators Approve ZAP Surgical's ZAP-X Platform
ZAP-X was previously granted NMPA’s Chinese Medical Device Evaluation Green Pathway.Michael Barbella, Managing Editor 09.06.23
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Xenex's 'Germ-Zapping' UV Robot Nets De Novo Nod
The LightStrike+ UV disinfection robot's run-time can be as low as two minutes.Sam Brusco, Associate Editor 09.05.23
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Cardiovascular
Cook Medical Gains Approval to Begin Aortic Aneurysm Treatment Study
Trial will evaluate efficacy of the Zenith Fenestrated+ Endovascular Graft with the Bentley InnoMed BeGraft system.Michael Barbella, Managing Editor 08.30.23
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Danaher Names New Environmental and Applied Solutions Company Veralto
The new company will be led by Jennifer L. Honeycutt.Charles Sternberg, Associate Editor 08.28.23
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Cardiovascular
Aquedeon Nets IDE Approval for Duett Vascular Graft
Duett connects native aortic arch branch vessels to the surgical graft without needing to circumferentially suture each anastomosis.Sam Brusco, Associate Editor 08.25.23
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Canadian Regulators Approve FemCath Intrauterine Catheter
Product is the first intrauterine catheter that allows clinicians to selectively evaluate a fallopian tube with natural saline and air contrast.Michael Barbella, Managing Editor 08.17.23
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Cardiovascular
FDA Approves Boston Scientific's POLARx Cryoablation System
The first-of-its-kind expandable cryoballoon catheter advances cryoablation therapy.Sam Brusco, Associate Editor 08.08.23
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HeartBeam Appoints Dr. Deborah Castillo as VP of Regulatory Affairs
Before joining HeartBeam, Dr. Castillo was director of regulatory affairs neuromodulation at LivaNova.Sam Brusco, Associate Editor 08.08.23
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Software & IT
The Top 7 AI Applications Transforming Medical Device Manufacturing
Medical manufacturers must understand how to apply AI effectively to fully capitalize on this potential.Online Exclusives Emily Newton, Editor-in-Chief, Revolutionized 08.08.23
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Heraeus Medevio Appoints Heiko Specht as President
Specht transitions the role from Dr. Peter Reimer.Charles Sternberg, Associate Editor 08.07.23
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Patient Monitoring
Researchers Introduce Non-Contact Approach for Heart Rate Estimation
Analyzes subtle color changes on the face to enable highly accurate heart rate estimation, even in scenes with ambient light fluctuations.Charles Sternberg, Associate Editor 08.07.23
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CE Mark Approval Granted to Establishment Labs' MI Surgical Tools
The Motiva Channel Dissector, Balloon, and Injector are designed to be used in next-generation minimally invasive aesthetic procedures.Michael Barbella, Managing Editor 08.07.23
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Cardiovascular
J&J's Biosense Webster Nets FDA Approval for AFib Ablation Products
The AFib ablation products received approval for use in a workflow without fluoroscopy.Sam Brusco, Associate Editor 08.04.23
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Health Canada Approval Granted for COVID-19 Treatment With Near Infrared Light
Device is intended for COVID-19 patients who experience acute symptoms within seven days of symptom onset.Michael Barbella, Managing Editor 08.03.23
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Digital Health
Study Validates Accuracy of Biospectal's Mobile Blood Pressure Measurement App
The company's OptiBP app calculates pressure using pulse wave analysis through a smartphone’s camera lens.Michael Barbella, Managing Editor 08.03.23
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Cardiovascular
AlucentVNS Granted FDA IDE Approval for U.S. Clinical Study
AlucentVNS is a light-activated, drug-coated balloon catheter.Sam Brusco, Associate Editor 08.02.23
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Thermally Conductive, Electrically Insulative Epoxy for Medical Device Applications
Product: EP40TCMed
