Medical Product Outsourcing

Cardiovascular

Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.

PR Newswire 01.19.21

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

CMS Expedites Breakthrough Device Access; Industry Applauds

New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’

MPO Staff 01.13.21

Exero Medical’s Smart Sensor Granted FDA Breakthrough Designation

The product provides data on internal tissue healing in the gastrointestinal tract.

Exero Medical 01.11.21

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

Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation

aerSleep II applies negative pressure over the external surface of the neck to hold airway open during sleep.

Business Wire 11.17.20

FDA Grants Breakthrough Device Designation for Magnetic Anastomosis Technology

The innovation is designed to help surgeons deliver less invasive solutions through magnetic compression anastomosis.

GI Windows Medical Corp. 11.13.20

Neurological

Salvia BioElectronics' Neurostim System for Chronic Migraine Earns Breakthrough Status

Bioelectronics solution addresses drug-refractory chronic migraine.

PR Newswire 11.03.20

Neurological

First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status

Revolutionary clinical-stage head device to beat back Alzheimer’s disease at home.

Business Wire 10.28.20

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

Cardiovascular

Medtronic's TYRX Driveline Wrap Device Earns Breakthrough Status

Securely holds a percutaneous driveline in patients receiving a ventricular assist device.

Medtronic 09.23.20

Digital Health

FDA Breakthrough Device Designation Granted for Algorithm to Predict Acute Kidney Injury

The algorithm monitors hospitalized patients and can predict acute kidney injury more than a full day before patients meet the clinical criteria for diagnosis.

Business Wire 09.08.20

Cardiovascular

PQ Bypass Earns Breakthrough Designation for Fully Percutaneous Femoral-Popliteal Bypass Device

First device of its kind to treat extremely long, complex blockages in the superficial femoral artery, according to the company.

Business Wire 09.03.20

AdvaMed, MDMA Support CMS Proposed Rule to Improve Coverage for ‘Breakthrough’ Technologies

Associations had pushed for updated rule for quite a while.

AdvaMed & MDMA 08.31.20

FDA Breakthrough Device Designation Granted for Fully Implanted Cochlear Implant

The Acclaim device offers the benefits of traditional partially implanted cochlear implants without the external components and associated disadvantages.

Business Wire 08.28.20

Neurological

Synchron’s Stentrode Brain-Computer Interface Earns Breakthrough Status

Stentrode is the only investigational, implantable device that does not require open brain surgery.

Business Wire 08.28.20

Mike on Medtech: Breakthrough Designation Program Update

Mike Drues and Sean Fenske revisit the breakthrough designation program and talk about the changes that have occurred since its inception.

Sean Fenske, Editor in Chief 08.28.20

Neurological

Neurolief's Relivion DP Headset for Major Depression Earns Breakthrough Status

Non-invasive multi-channel brain neuromodulation helps those who haven't received adequate improvement from drug treatment.

Business Wire 08.11.20

Surgical

FDA Grants Breakthrough Device Designation for Ethicon’s Microwave Ablation Technology

Provides a minimally invasive option for soft tissue lesions.

Ethicon 07.30.20

Diagnostics

Breakthrough Dental Device Detects Very Early Cavities Well Before X-Rays

New Ortek-ECD device developed and tested at Stony Brook University School of Dental Medicine.

PR Newswire 07.23.20

Xealth Receives 2020 MedTech Breakthrough Award for its Digital Health Platform

The awards program attracted more than 3,750 nominations worldwide.

Business Wire 07.21.20

Cardiovascular

FDA Breakthrough Device Designation Granted for Thoraflex Hybrid Graft

The product combines a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft.

Terumo Aortic 06.25.20

FDA Grants Breakthrough Device Designation to Vapotherm's Oxygen Assist Module

Vapotherm's OAM is a module for use with most versions of its Precision Flow systems.

Business Wire 06.05.20

Neurological

Noctrix Health's Wearable Restless Legs Syndrome Therapy Earns Breakthrough Status

NTX100 Neuromodulation therapy treats adults with primary moderate-severe RLS refractory to medications.

PR Newswire 06.03.20

New Breakthrough Antimicrobial Technology Kills Coronavirus on Contact

CovaGuard provides persistent protection by trapping and deactivating microbes over an extended period of time, up to four days.

Business Wire 06.02.20

Cardiovascular | Surgical

Thermedical’s SERF Ablation System Earns Breakthrough Status

Offers the potential for an entirely new therapy for ventricular tachycardia.

Business Wire 05.20.20

Neurological

PhotoPharmics' Non-Invasive Parkinson's Phototherapy Wins Breakthrough Status

PhotoPharmics is currently raising a B round to finance their pivotal, phase 3 study.

Business Wire 04.30.20

Aria CV Announces $31 Million in Series B Funding

Money will support the Aria CV Pulmonary Hypertension System Feasibility Study.

Business Wire 04.24.20

Health Canada Expands Emergency Use of CeraShield Endotracheal Tube

May help prevent deadly ventilator-associated bacterial infections and complications in COVID-19 patients.

PR Newswire 04.24.20

Cardiovascular

VisCardia's Heart Failure Therapy Gains Breakthrough Designation

Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.

NewsWire 04.23.20

Cardiovascular

Endospan's Aortic Arch Stent Graft Earns Breakthrough Status

Addresses significant unmet clinical need for difficult-to-treat aortic arch anatomy.

Business Wire 04.20.20

Cardiovascular

Transcatheter Tricuspid Valve Replacement System Gains Breakthrough Status

Cardiovalve is first company to receive FDA early feasibility study approval for both tricuspid regurgitation and mitral regurgitation indications.

Business Wire 04.17.20

Device Measures QT Segments in COVID-19 Patients Using Hydroxychloroquine

BardyDx’s CAM Patch will be used at hospitals across the Seattle area to monitor cardiac rhythms for COVID-19 patients on HCQ.

Bardy Diagnostics Inc. 04.09.20

Diagnostics

DNAe’s Point-of-Need Sequencing Diagnostic Earns Breakthrough Status

Can support tests for infectious diseases, cancer, infection control, and preparedness and response for pandemics.

Business Wire 04.09.20

Polarity Medical Developing Virus-Killing UV-C Light

Technology is designed to automatically sterilize doorknobs, railings, pin pads and other CDC-defined high-touch areas.

PR Newswire 04.08.20

Embracing the ‘Amazon Effect’ to Improve Financial Health

Healthcare product suppliers can improve their image to customers through automated, easy-to-use transactional utilities.

Online Exclusives Mitchell Rose, SVP and GM, Corporate Segment, Billtrust 04.08.20

Emergency Use Authorization Granted for N8 Medical CeraShield Endotracheal Tubes

The tubes have anti-fouling coating designed to prevent deadly bacterial infections that occur in ventilated patients with respiratory viral infections.

PR Newswire 04.03.20

Tubing & Extrusion

Pathways to Care: Tubing Technologies

Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially.

Mark Crawford, Contributing Writer 04.01.20

R&D & Design

Why Outsourcing Is in: Piecing Out Projects Makes Sense

Getting outside help is a trend both large and small medical device companies are following as outsourcing engineering services continues to gain traction.

Dawn A. Lissy, President & Founder, Empirical 04.01.20

Cardiovascular