Medical Device / MedTech
LivingPHOENIX Previews POGMENT® Collagen ECM Devices
LivingPHOENIX presented its POGMENT® Triple-Helix Biomimetic Collagen-Based ECM medical devices at the EU-China Business Meeting.
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Medical Device / MedTech
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Medical Device / MedTech
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Medical Device / MedTech
Medtronic Vitalis Pacemaker Portfolio Secures CE Mark
Medical Device Network reports Medtronic’s five-device Vitalis pacemaker portfolio has secured CE marking.
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Medical Device / MedTech
Teleflex earns Breakthrough Device designation for Freesolve RMS
MassDevice reports Teleflex received FDA Breakthrough Device designation for the Freesolve RMS resorbable scaffold.
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Medical Device / MedTech
UK confirms indefinite recognition of CE-marked devices
Med Techinsights reports that Great Britain will continue recognising CE-marked medical devices and in vitro diagnostic devices.
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Medical Device / MedTech
FDA Accelerated Approval for Ultomiris in Adult IgAN
AstraZeneca reports FDA accelerated approval of Ultomiris to reduce proteinuria in adults with primary IgA nephropathy at risk of progression.
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Medical Device / MedTech
UK Confirms Indefinite Recognition of EU CE Marks
Medical Device Network reports the UK will continue recognizing EU CE-marked medtech, shelving plans for a separate UK tag by 2030.
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Medical Device / MedTech
Alcon Portfolio Expansion Highlights Eyecare Acquisition Activity
Pluang cites Alcon acquisitions and FDA approvals as factors supporting its expanding eyecare portfolio and long-term demand outlook.
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Medical Device / MedTech
J&J Debuts Shockwave C2 Aero Fly Coronary IVL Catheter
Medical Product Outsourcing reports J&J debuted the Shockwave C2 Aero Fly coronary IVL catheter in the U.S.
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Medical Device / MedTech
FDA Approves Edwards’ Pascal Precision for Tricuspid Repair
MassDevice reports FDA approval of Edwards’ Pascal Precision for tricuspid valve repair in tricuspid regurgitation.
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Medical Device / MedTech
Michigan Instruments Acquires KEM Enterprises
Woodtv reports that Kentwood-headquartered Michigan Instruments acquired Ada Township medical device company KEM Enterprises.
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Medical Device / MedTech
FDA Warns Against Two Medical Device Products
FDA advisories warn healthcare professionals and the public not to purchase or use a blood pressure monitor and disposable face mask.
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Medical Device / MedTech
AmCham Calls for Separate Medical Device Rules in Bangladesh
AmCham has called for a dedicated framework for medical devices and equipment, En reports, linking it to technology access and patient services.
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Medical Device / MedTech
Audacity North Launches MedTech Hub in Aurora
Auroratoday reports that Audacity North has launched in Aurora, bringing testing facilities, university expertise and business mentorship together.
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Medical Device / MedTech
FDA Approves 28 Smaller Motiva Breast Implant Sizes
Newbeauty reports FDA approval of 28 new Motiva breast implant sizes, including some as small as 105 cc.
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Medical Device / MedTech
Medtronic Wins CE Mark for Vitalis Cardiac Pacemaker Portfolio
MedTech Dive reports that a CE mark clears Medtronic to sell Vitalis conduction system pacing therapy devices in Europe.
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Medical Device / MedTech
Elanco Earnings Record Draws Focus Ahead of Results
Simplywall reports Elanco Animal Health outperformed earnings forecasts in its last two reported quarters ahead of upcoming results.
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Medical Device / MedTech
AmCham seeks separate medical device rules and faster registration
Tbsnews reports AmCham made five recommendations on medical devices as a state minister said approvals will be expedited.
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Medical Device / MedTech
MNEX Invests P180 Million in Batangas Components Plant
Newsbytes reports MNEX is investing P180 million in a Batangas plant for precision-molded components, with production targeted for early 2027.
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Medical Device / MedTech
Olympus Warning Letter Follows Six FDA Facility Inspections
AboutLawsuits reports that an FDA warning letter to Olympus followed inspections of six manufacturing facilities.
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Medical Device / MedTech
FDA Early Alert Covers Some Edwards Commander M Systems
Insights reports an FDA early alert after balloon ruptures during inflation involving some Commander M systems used with Sapien M3.
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Medical Device / MedTech
MiniMed Completes Separation From Medtronic
MiniMed completed its separation from Medtronic and began its first day as a fully independent company, Investing News Network reported.
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Medical Device / MedTech
MiniMed Completes Separation From Medtronic
MiniMed completed its separation from Medtronic and began its first day as a fully independent company, Investing News Network reported.
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Medical Device / MedTech
Modular Medical Launches Digital Learning Tools
Modular Medical has launched digital learning tools to support adoption as it prepares for full commercialization, Valuethemarkets reports.
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Medical Device / MedTech
FDA Grants 510(k) Clearance to Stryker’s Sonopet 3
Medical Device Network reports FDA 510(k) clearance for Stryker’s Sonopet 3 ultrasonic platform for bone and soft tissue removal.
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Medical Device / MedTech
Intuitive Surgical Set to Report Third-Quarter Results
TradingView says Intuitive Surgical is scheduled to report third-quarter results after the market closes on Oct. 20.
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Medical Device / MedTech
Gore Wins FDA Approval for VBX Stent Graft in FEVAR, BEVAR
Medical Product Outsourcing reports FDA approval for Gore’s VBX Stent Graft as a bridging stent in fenestrated and branched aortic repair.
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Medical Device / MedTech
FDA approves Gore bridging stent graft for complex aortic repairs
MassDevice reports FDA approval of Gore’s Viabahn VBX endoprosthesis for use in FEVAR and BEVAR procedures.
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Medical Device / MedTech
FDA approves expanded Gore VIABAHN VBX use in FEVAR and BEVAR
Gore announced FDA approval of an expanded indication for its VIABAHN VBX Balloon Expandable Endoprosthesis in FEVAR and BEVAR.
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Medical Device / MedTech
Vantis Vascular Receives FDA Clearance for 6F CrossFAST Model
Yahoo News reports FDA 510(k) clearance for Vantis Vascular’s new 6F CrossFAST delivery system model.
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Medical Device / MedTech
Apple Watch Sleep Apnea Detection Launches in China
KuCoin reports that Apple Watch sleep apnea detection launched in China through an OTA update tied to iOS and watchOS upgrades.
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Medical Device / MedTech
Chip and Cloud Partnerships Put Faster Diagnostics in Focus
Kingsresearch says partnerships with chipmakers and cloud firms are transforming U.S. MedTech by enabling faster diagnostics.
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Medical Device / MedTech
UCT partners with BRICS peers on medical device innovation hub
University of Cape Town partners with institutions in India, Russia and Brazil to develop medical device innovation and manufacturing capacity.
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Medical Device / MedTech
JenaValve recalls certain TAVR delivery catheters
Cardiovascularbusiness reports a Class II recall of certain JenaValve TAVR delivery catheters over Trilogy system deployment concerns.
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Medical Device / MedTech
Seeking Alpha Highlights NVE’s Medical-Sensor Focus
Seeking Alpha’s NVE Corporation analysis cites proprietary spintronics and implantable medical-device sensors.
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Medical Device / MedTech
Korean Diagnostic Makers Expand South African Sales Channels
Asiae reports Korean diagnostic and imaging equipment companies are expanding sales channels in South Africa while pursuing African market entry.
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Medical Device / MedTech
FDA approves heart valve designed to grow with children
Gulfcoastmedia reports the FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for pediatric patients.
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Medical Device / MedTech
FDA Approves Asahi Kasei Drug for Persistent Herpes Infections
Investing.com reports that the US FDA approved an Asahi Kasei drug for persistent herpes infections.
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Medical Device / MedTech
Jdsupra Frames Reimbursement as a Launch Planning Element
Jdsupra examines reimbursement alongside patents, FDA considerations and strategic timing in medical device commercialization planning.
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Medical Device / MedTech
Neuracle’s IPO Prospectus Centers on NEO-ONE SCI
Finance reports that Neuracle’s STAR Market IPO prospectus focuses on NEO-ONE SCI, an approved invasive brain-computer interface device.
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Medical Device / MedTech
SurGenTec Signs Exclusive License Deal for Vantage System
SurGenTec announced an exclusive license agreement with Allevion Medical involving the Vantage spinal decompression system.
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Medical Device / MedTech
Sonorous gains FDA IDE for pulsatile tinnitus stent trial
Medical Device Network reports Sonorous received FDA IDE approval for a pivotal trial of its BosSTENT device.
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Medical Device / MedTech
Centinel Spine Discloses Revenue Rise in U.S. IPO Filing
Centinel Spine disclosed a revenue rise in a U.S. IPO filing, TradingView reported, amid uncertain conditions for the fall IPO market.
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Medical Device / MedTech
Boston Scientific Names Joseph M. Fitzgerald Chief Operating Officer
Medical Product Outsourcing reports Boston Scientific appointed Joseph M. Fitzgerald as executive vice president and COO, effective Jan. 1, 2027.
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Medical Device / MedTech
FDA Issues Two Medical Device Public Health Warnings
The FDA warned healthcare professionals and the public not to purchase or use TOPCARE ELASTIC BANDAGE and HUAKUN BV FILTER.
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Medical Device / MedTech
OGRD Alliance Advances PLPC Platform After APHELAR Milestone
TradingView reports OGRD Alliance is advancing its PLPC platform with expanded licensing, commercialization and strategic capital frameworks.
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Medical Device / MedTech
TSC Life Receives FDA Clearance for Mistral-Air MA1400
Citybiz reports FDA clearance for TSC Life’s Mistral-Air MA1400 forced-air warming system.
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Medical Device / MedTech
Zenflow Raises $52M, Adds Cook Medical as U.S. Distributor
MedTech Dive reports Zenflow raised $52M as Cook Medical became its U.S. distributor in the urology device market.
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Medical Device / MedTech
Saluda Medical Releases CAP24™ Across the US
Saluda Medical announced the full US commercial release of its CAP24™ Surgical Paddle Lead following FDA approval earlier this year.
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Medical Device / MedTech
Innova Adds Mexicali Molding Assets and Production Space
Innova Engineered Plastics purchased ATMEX assets in Mexicali, adding injection molding machines and production space, Manilatimes reported.
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Medical Device / MedTech
UK accepts continuous monitoring plan for AI medical devices
Fierce Biotech reports the UK accepted 44 AI healthcare recommendations, including continual MHRA monitoring of AI-based devices.
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Medical Device / MedTech
FDA Clears Expanded Motiva Implant Range in U.S.
FDA clearance adds 28 Motiva SmoothSilk Round and Ergonomix breast implant sizes for the U.S. market, Simply Wall St reports.
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Medical Device / MedTech
Znext Launches Ardeevo for Medical Technology Certification
Startupbusiness reports that Znext launched Ardeevo to help companies certify medical technologies and received a pre-seed investment.
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Medical Device / MedTech
Inspire Medical Systems Highlights Q2 Specialty Device Review
TradingView’s Q2 specialty medical device earnings review identifies Inspire Medical Systems among the industry’s standout performers.
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Medical Device / MedTech
FDA Approves Additional U.S. Sizes for Motiva Breast Implants
Establishment Labs announced FDA approval of an expanded U.S. size range for Motiva SmoothSilk Round and Ergonomix breast implants.
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Medical Device / MedTech
GE HealthCare to Buy Sofie Biosciences for $945 Million
GE HealthCare said it will buy Sofie Biosciences for $945 million in cash to strengthen PET imaging drug manufacturing and distribution.
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Medical Device / MedTech
Medtronic Drug-Coated Balloon Gets FDA Breakthrough Status
MedTech Dive reports FDA breakthrough status for Medtronic’s drug-coated balloon, which the company plans to study below the knee.
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Medical Device / MedTech
Inner Logic Raises $11.5M for Procedural Device Infrastructure
Medical Product Outsourcing reports Inner Logic raised $11.5 million to build autonomy-enabling infrastructure for procedural devices.
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Medical Device / MedTech
Mitria Medical teams with T45 Labs on mitral repair implant
MassDevice reports Mitria Medical is joining Silicon Valley medtech incubator T45 Labs and bringing on a new CEO.
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Medical Device / MedTech
Medtronic Reports AMA Category I CPT Code Approvals
Investing News Network reports Medtronic received AMA approval of new Category I CPT codes for Altaviva and Symplicity Spyral.
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Medical Device / MedTech
Hilo Launches Hilo Core Blood Pressure Health System in U.S.
Hilo has launched Hilo Core in the U.S., positioning the system to deliver long-term blood pressure insights, Medical Product Outsourcing reports.
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Medical Device / MedTech
Surmodics Acquires Alta Biomed to Expand Device Capabilities
Pulse2 reports Surmodics acquired Alta Biomed’s business, adding surface technologies and testing for blood- and tissue-contacting devices.
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Medical Device / MedTech
Inspire Billing Codes Scheduled for 2028
Stock Titan reports new Inspire billing codes are scheduled for 2028, with Medicare payment valuations expected in July and November 2027.
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Medical Device / MedTech
FDA Approves Cedarville Device for Neck Injuries
Yahoo News reports FDA approval of a Cedarville University device created to treat traumatic neck injuries.
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Medical Device / MedTech
Banner Capital Rolls Up Three Plastics Makers for Medical Device Platform
Dealroom.co reports Banner Capital has agreed to acquire three plastics makers’ businesses for a new medical device platform.
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Medical Device / MedTech
Cellmax launches locally developed wound care products
Cellmax has launched wound care products developed after eight years of research and registered with the Medical Device Authority.
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Medical Device / MedTech
Surmodics Acquisition Adds PzF Surface Technology
Medical Product Outsourcing reports Surmodics’ acquisition of Alta Biomed adds thin-film PzF surface technology and a West Coast testing hub.
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