Medical Product Outsourcing

Cardiovascular

Pandemic Likely to Reduce Volume of Peripheral Vascular Procedures

The rescheduling of elective peripheral vascular procedures may result in a backlog of patients in the future.

GlobalData 06.04.20

Cardiovascular

The COVID-19 Pandemic May Reduce Peripheral Vascular Procedures

New government directives and hospital guidelines will impasct the industry, says GlobalData.

GlobalData 04.06.20

AngioDynamics Appoints Interim CFO to Permanent Position

New CFO also serves as general counsel; company will now search for a replacement.

Business Wire 03.20.20

Surmodics Names New Vice President of Clinical Affairs

Former Edwards Lifesciences executive has more than 20 years of medical affairs, medtech, and healthcare experience.

Business Wire 03.13.20

Intact Vascular Expands Tack Endovascular System Portfolio Offering

New larger implant enables focal dissection repair across a wider range of vessel sizes.

Business Wire 03.09.20

Cardiovascular | Surgical

FDA OKs Stereotaxis' Genesis Robotic Magnetic Navigation

Robotic navigation of magnetic ablation catheters treats heart rhythm disorders.

GlobeNewswire 03.06.20

Cardiovascular

Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies

Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.

Sam Brusco, Associate Editor 03.04.20

FDA Approves Ra Medical's Atherectomy Clinical Study

The multicenter, open-label trial will enroll up to 100 patients with symptoms of peripheral vascular disease.

Business Wire 03.02.20

Cardiovascular

AngioDynamics Launches Atherectomy System Pilot Study

Study is designed to gather scientifically backed data to differentiate the AURYON system from competitive products.

Business Wire 02.27.20

Cardiovascular

Emboline Completes Enrollment in Trial for Protection Catheter

Results from first 24 patients show excellent safety profile and technical performance, with significant debris capture and removal.

Business Wire 02.24.20

Surgical

Philips Reveals Upgrades to Mobile C-arm Platform

Zenition's new interface and imaging capability will boost OR workflow.

Philips 01.27.20

Japanese Approval Granted for Shape Memory Medical's IMPEDE Embolization Plug Family

The Plug is designed to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Business Wire 01.23.20

Cardiovascular | Surgical

Cook Medical Launches TriForce Peripheral Crossing Set

Supports procedures to treat patients with vascular obstructions.

Business Wire 01.15.20

AngioDynamics Appoints Interim CFO

The company's outgoing chief financial officer will remain with the firm through filing of the second fiscal quarter financial documents.

Businesswire 11.26.19

Medtronic Drug-Coated Balloon Approved by FDA

Designed to treat arteriovenous fistula lesions.

Medtronic plc. 11.22.19

Cardiovascular | Surgical

Shape Memory Medical's TrelliX Embolic Coil System Gains CE Mark

The coil system obstructs or occludes blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Business Wire 10.21.19

Cardiovascular

FDA OKs Sky Medical Technology's geko Device to Prevent Venous Thrombosis

Sky Medical Technology furthers presence in $3.5B U.S. market for venous thromboembolism prevention

PR Newswire 10.11.19

Cardiovascular | Surgical

Medtronic Recalls Catheters Due to Separation and Fragmentation Issue

Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device.

U.S. Food and Drug Administration 10.08.19

Cardiovascular | Contract Manufacturing | Neurological | Surgical

Integer Acquires US BioDesign Assets

The acquisition will add the differentiated capability for complex braided and formed biomedical structures to Integer’s portfolio.

Integer Holdings Corporation 10.08.19

AngioDynamics Acquires Eximo Medical

Expands AngioDynamic’s product portfolio.

AngioDynamics Inc. 10.07.19

Former J&J Executive Joins AngioDynamics Board of Directors

New member served as corporate vice president for Worldwide Government Affairs & Policy at Johnson & Johnson.

Business Wire 09.25.19

Cardiovascular

First Patients Enrolled in Reflex Medical's DEEPER OUS Spur Stent Trial

The Temporary Spur Stent System is a retrievable stent designed to treat severely calcified infrapopliteal disease.

Business Wire 09.23.19

Cardiovascular | Tubing & Extrusion

Heraeus Medical Components Acquires Via Biomedical

Expands capabilities and development services for catheter technologies.

Heraeus Medical Components 09.06.19

Ablative Solutions Appoints President and CEO

Veteran leader brings extensive experience from both pharmaceutical and device industries.

Business Wire 09.04.19

LivaNova Welcomes New Board Member

Most recent addition boasts a career spanning more than 25 years in the healthcare and medical technology industry.

Business Wire 08.07.19

Cardiovascular | Surgical

Cardiovascular Systems Buys Gardia's WIRION Embolic Protection System

CSI to commercialize product upon successful manufacturing transfer.

Business Wire 08.06.19

Cardiovascular

Orchestra BioMed Partners With Terumo Corporation on Development of Virtue Sirolimus-Eluting Balloon

Virtue SEB is expected to become a flagship therapeutic product for Terumo and will strengthen its U.S. and global portfolio of interventional solutions.

Globe Newswire 08.01.19

Cardiovascular

Cardiovascular Systems Inc. Enrolls First Patient in REACH PVI Clinical Study

Trial to study treatment of peripheral artery disease with orbital atherectomy via radial access.

Business Wire 07.31.19

Materials

Beyond the Surface: Examining Coatings and Surface Treatment Options

Advancements in coatings technologies enable greater benefits to manufacturers for their devices.

Mark Crawford, Contributing Writer 07.30.19

Safety, Efficacy of Philips’ Stellarex .035 Low-Dose Drug-Coated Balloon Shown in Clinical Trial

No significant difference in mortality was found compared to standard of care through three years.

Royal Philips 07.18.19

AngioDynamics Receives FDA OK to Initiate Study for Use of NanoKnife in Prostate Cancer Treatment

The prospective, non-randomized pilot study includes six subjects at up to three clinical sites.

Business Wire 07.12.19

AngioDynamics Enrolls First Patient in NanoKnife DIRECT Clinical Study

Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer.

Business Wire 06.27.19

Cardiovascular

Intact Vascular Launches Tack Endovascular System in the U.S.

The first-of-its-kind dissection repair device is implanted post-angioplasty to resolve dissections in patients with peripheral arterial disease.

Business Wire 06.20.19

Clinical Innovations Hires VP of Business Development and Strategy

Medical device industry veteran will accelerate company’s global M&A strategy.

Clinical Innovations 06.12.19

AngioDynamics Selling its NAMIC Fluid Management Business to Medline Industries for $167.5 Million

Besides the NAMIC brand, deal includes manifolds, contrast management systems, closed fluid systems, disposable transducers, and interventional accessories.

Business Wire 06.04.19

Patient Monitoring

Keeping Tabs on Tissue Oxygen in Peripheral Artery Disease Patients

Insights from those who have helped develop and test the Lumee Oxygen Platform on its benefits over traditional monitoring methods.

Online Exclusives Sean Fenske, Editor-in-Chief 05.30.19

Cardiovascular | Surgical

Philips Launches New IntraSight Interventional Applications Platform

The platform will seamlessly integrate intravascular imaging and physiology applications for image-guided procedures.

GlobeNewswire 05.20.19

AngioDynamics Receives FDA Approval to Initiate NanoKnife DIRECT Clinical Study

Study will examine the efficacy in the NanoKnife's treatment of Stage III pancreatic cancer.

AngioDynamics Inc. 05.15.19

OARtrac Radiation Dose Monitoring System Gets Expanded FDA Clearance for Electron Radiation Therapy

The additional indications clear the OARtrac System for use with patient-specific, pre-calibrated Plastic Scintillating Detector (PSD) sensors.

Business Wire 05.14.19

Cardiovascular | Surgical

FDA Approves Intact Vascular's Tack Endovascular System

First-of-its-kind treatment for post-angioplasty above-the-knee dissections now available.

Business Wire 04.15.19

Cardiovascular

Vesper Medical Hires Chief Medical Officer

New executive team member was chief medical officer for Merit Medical.

Business Wire 04.12.19

Cardiovascular | Surgical

£1.1M Project to Develop New Biodegradable Stents

The project will see bioresorbable stents treating severe vascular disease and dissolving within two years after implant.

University of Bristol 04.10.19

Teleflex Receives FDA PMA Approval for MANTA Vascular Closure Device

Product is indicated for closure of femoral arterial access sites while reducing time to hemostasis.

Business Wire 03.20.19

Cardiovascular | Contract Manufacturing | Neurological | R&D & Design

Minimally Invasive Device Segments from Creganna Medical

Read about a variety of Minimally Invasive Device Solutions from Creganna Medical

Medical Device Incubator CEO Appointed to PQ Bypass Board of Directors

Company is expanding its board to support future phase of growth and development.

Business Wire 03.04.19

Cardiovascular

Intact Vascular Launches the Tack Endovascular System in the European Union

First commercial use took place in Germany.

Business Wire 02.19.19

Cardiovascular

Intact Vascular Announces Enrollment Completion of TOBA II BTK Clinical Trial

Study is designed to demonstrate safety, efficacy of the Tack Endovascular System in treating post-PTA dissections below the knee.

Business Wire 02.12.19

Cardiovascular

InnovHeart Appoints New Chief Executive Officer and Board Member

Company's latest leader has more than 22 years of experience in the medical device industry, including 18 in the interventional cardiovascular market.

PR Newswire 02.06.19

Materials