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Medtech Medical Devices

Mammotome Unveils HydroMARK™ Plus: Innovative Breast Biopsy Site Marker

"I am excited for this innovative biopsy marker to come to market," said Radiologist Dr. Evita Singh, Director of Breast Imaging at Karmanos Cancer In...

August 22, 2023 | News

magAssist's NyokAssist™️ granted Designation by the FDA as a Breakthrough Device

Interventional VADs have been proven as an effective clinical therapy to provide mechanical circulatory support for high-risk percutaneous interventions, t...

August 22, 2023 | News

Medtronic announces cash dividend for second quarter of fiscal year 2024

The board of directors of Medtronic plc (NYSE:MDT) on Thursday, August 17, 2023, approved an increase in the company's cash dividend for the seco...

August 21, 2023 | News

NAVI Raises $2.4 Million for Breakthrough Medical Device Aiding Critically Ill Newborns

After a successful raise Navi Medical Technologies has closed a $2.4 million round of funding, which included a $700,000 lead in...

August 03, 2023 | News

BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k)...

August 02, 2023 | News

FDA Clears Terumo's Reveos® Automated Whole Blood Processing System for U.S. Commercial Use

Terumo Blood and Cell Technologies (Terumo BCT) announces U.S. Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing ...

August 02, 2023 | News

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The FDA clearance also includes the company's core technology platform, the proprietary AXINON® System, that incorporates diagnostic tes...

August 01, 2023 | News

KORU Medical Systems Announces Late-Stage Endocrinological Biologic Collaboration

Under terms of the Agreement, Koru Medical will validate the Freedom Infusion System for use with the company’s drug. The drug developer is expected ...

July 31, 2023 | News

Palliare Announces EU CE Mark Approval Under New Medical Devices Regulation

Palliare, a leading developer of advanced insufflation technologies, has received EU CE Mark certification under the new EU Medical Devices Regulation (MDR...

July 31, 2023 | News

Alma Veil™ Launched for U.S. Market by Sisram Medical's Alma

Alma Veil is the core instrument equipped with three gold-standard technologies conveniently integrated into a single handpiece: 532 nm laser:...

July 26, 2023 | News

Aevice Health Secures US FDA Clearance for Smart Wearable Stethoscope-Enabled Remote Respiratory Monitoring

The AeviceMD received U.S. FDA 510(k) clearance as a Class II medical device. ● The AeviceMD is part of a broader system that continuously monitors bioma...

July 21, 2023 | News

Lunit's AI Solution Impacts Radiologists' Lung Cancer Diagnosis - Published in Radiology

Findings from a recent study demonstrate that medical AI solutions with only high diagnostic accuracy can significantly improve the reading performance of ...

July 04, 2023 | News

Lumos Receives US FDA Clearance for FebriDx®

The clearance allows FebriDx to be marketed in the US for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infecti...

July 04, 2023 | Regulatory

Japan Approves CXR-AID for Reimbursement, Boosting Market Expansion for Lunit

Lunit (KRX:328130.KQ), a global provider of cancer diagnostics solutions, today announced that CXR-AID, FujiFilm's AI solution for chest X-ray analysis, po...

June 27, 2023 | News

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