Medical Product Outsourcing

Materials

Peak Performance Compounding Achieves ISO 13485:2016, 9001:2015 Certifications

ISO certifications achieved for toll processing and formulation of thermoplastic compounds for the medical and industrial markets.

Peak Performance Compounding 08.18.20

Materials

Peak Obtains ISO 13485:2016 and 9001:2015 Certifications

Offers toll processing and custom formulations for the medical and industrial markets.

Peak Performance Compounding Inc. 08.04.20

3DEO Achieves ISO 9001:2015 Certification

The certification took three months, roughly half the average time it takes for conventional implementation.

3DEO 07.17.20

Universal Photonics Achieves ISO 9001:2015 Certification

Company's Central Islip, N.Y., facility joins its already-certified Vernon, N.Y., facility, creating a comprehensive ISO 9001:2015 certified operation.

Universal Photonics Inc. 06.05.20

Battelle Offering Mask Decontamination Services at No Charge

The $400 million cost of decontaminating N95 respirator masks across 60 deployment sites will be funded by the federal government.

Business Wire 04.13.20

Pentax Medical to Pay $43 Million Over Misbranded Endoscopes

Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.

U.S. Department of Justice 04.08.20

PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables

Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.

PhysIQ 04.07.20

Mack Molding Names Vice President of Business Development

Company also has added positions and/or promoted workers in quality, business development, customer management, manufacturing, purchasing and human resources.

Mack Molding 04.02.20

A Manufacturer’s Secret Weapon: R&D Tax Credits

For small and medium-sized medical device manufacturers, qualifying for the tax credits could result in an unexpected windfall.

Chris Lake, President, R&D Tax Credit Consultant 04.01.20

Battelle Develops Decontamination System for Medical Protective Equipment

Organization receives FDA emergency use authorization to reprocess previously worn PPE.

Business Wire 03.30.20

Surface Disinfectant Available to Combat COVID-19

Ace Disinfectant is a one-step ready-to-use spray that can be used on all surfaces as an Eco-friendly disinfectant.

Ace Healthy 03.30.20

Digital Health

9 Ways AI Will Disrupt Healthcare in the Next 5 Years

The technology could impact areas from stroke detection to mental health to access to specialized care.

Online Exclusives Scott Molina, IT Consultant 03.26.20

QIAGEN Names New CEO

Thierry Bernard has been with QIAGEN since 2015.

QIAGEN 03.25.20

Diagnostics

COVID-19 Self-Assessment Tool Offered by MyTelemedicine

Leading telemedicine provider seeks to rapidly deploy consumer-friendly solutions to mitigate spread of deadly coronavirus.

PR Newswire 03.18.20

Diagnostics

Coronavirus Detectable With IDbyDNA Explify Respiratory Test

Explify Respiratory is a validated laboratory developed test for respiratory pathogens, including human coronaviruses.

Business Wire 03.10.20

Cardiovascular

FDA OKs Access Vascular's Next-Gen HydroPICC

Biomaterial platform in peripherally inserted ventral catheter (PICC) may virtually eliminate clot accumulation.

PR Newswire 03.04.20

Flat Panel Medical X-Ray Detectors Outperforming Analog Counterparts

Growth in CT and radiography tests and the total number of tests performed annually have led to significant demand for digital radiography detectors.

Future Market Insights 03.04.20

R&D & Design

The New Source of Medtech R&D

Do alliances between academia and the medical device industry represent the future of research and development in the medical device industry?

Sean Fenske, Editor-in-Chief 03.04.20

Use of Endosurgery Devices in Laparoscopic Surgeries to Grow

Increase is attributable to growth in use of surgical staplers, advancements in endomechanical devices, and a rise in various types of endosurgery.

Transparency Market Research 03.04.20

Surgical

Baxter Launches Next-Gen Staple Line Reinforcement Material

New generation is two times faster to prepare compared to the previous version.

Business Wire 02.27.20

Machining & Laser Processing

Keeping Pace with Laser-Driven Technologies

Laser Light Technologies — Experts at the laser manufacturing of high-precision products

Cardiovascular

FDA OKs Fresenius' Novalung for Respiratory, Cardiopulmonary Failure

Extracorporeal membrane oxygenation (ECMO) system cleared for long-term use.

PR Newswire 02.25.20

415 CAPITAL Closes New Medtech Venture Capital Fund

The fund will invest in medical device companies in Europe, Israel and the United States.

Business Wire 02.25.20

Diagnostics

WaveGuide Launches Formµla Portable NMR Device

Performs rapid screening and diagnostics of solid and liquid substances.

Business Wire 02.24.20

STAAR Surgical Gains Supplemental Lens Approval for EVO Visian ICL

CE Mark addresses post-cataract-surgery myopia, hyperopia and astigmatism patients with residual refractive error.

Business Wire 02.19.20

Digital Health

A Wearable Health Monitor That Never Needs Charging

Medirom and MATRIX Industries partnering to develop device powered by body heat.

Business Wire 02.14.20

Bactiguard's CEO Steps Down

Replacing 16-year leader Christian Kinch is CFO and deputy CEO Cecilia Edström.

PR Newswire 02.05.20

Cardiovascular

Medtronic Receives CE Mark for Portfolio of Defibrillators

Next-gen tech automatically adjusts to patient needs and offers heart failure diagnostic insights.

Globe Newswire 01.30.20

Study: New Approach to Dialysis Access Leads to High Patient Satisfaction

Significant success rates reported in patients who had their fistulas created with the Ellipsys Vascular Access System.

Videos Access Solutions

Cardiovascular

FDA OKs Eko's AFib and Heart Murmur Detection Algorithms

Converts the classic stethoscope into a powerful early detection tool.

Business Wire 01.28.20

New CFO Assumes Role at Intersect ENT

Owens & Minor executive has more than two decades of experience in healthcare.

Business Wire 01.22.20

Machine Keeps Human Livers Alive for a Week Outside the Body

This breakthrough may increase the number of available organs for transplantation.

University of Zurich 01.15.20

Cardiovascular

Data Show Zilver PTX Leads to Fewer Complications, Shorter Hospital Stays

Additionally, the procedure with Zilver PTX takes about half the time as bypass surgery.

Business Wire 01.15.20

Health Canada Approves Tandem Diabetes Care's t:slim X2 Insulin Pump

The t:slim X2 pump is up to 38 percent smaller than other pumps yet can hold up to 300 units of insulin.

Business Wire 01.14.20

Diagnostics | Digital Health

KA Imaging Prepares to Shake Up Healthcare Market With Digital X-Ray Detector

The company's technology overcomes limitations of traditional and dual-energy X-ray imaging.

Business Wire 01.14.20

Cardiovascular

Medtronic Gains CE Mark for InterStim Neurostimulator and MRI Leads

Offers lifestyle-friendly choices in sacral neuromodulation therapy to Europeans suffering from incontinence.

Medtronic plc 01.13.20

Zephyr Valve Scores High in GOLD Report for its Emphysema Treatment

Data affirms that endobronchial valves like Zephyr's are a proven, viable, minimally-invasive treatment option for severe emphysema.

Businesswire 01.02.20

Toughened, Urethane Based Epoxy System Meets USP Class VI Specifications

Product: EP30DPBFMed

Dr. Stephen Hahn Confirmed as New FDA Leader

He has never worked in a government position, so his potential FDA agenda is currently unknown.

Sam Brusco, Associate Editor 12.13.19

Cardiovascular | Diagnostics | Patient Monitoring

Ladies First: An Examination of the Women's Health Device Industry

Economic burden for women's diseases tops $500 billion, but women’s health makes up about 4 percent of total R&D funding for healthcare products and services.

Online Exclusives Hrishikesh Kadam, Research Content Developer, Global Market Insights (GMI) 12.11.19

Celmatix Sues Research Partner 23andMe for $100M

Celmatix claims breaches of the parties' agreement and tortious interference with efforts to raise capital.

PR Newswire 12.11.19

Cardiovascular

FDA Grants Supplemental-PMA Approval to Impulse Dynamics' Next-Generation Optimizer Smart System

Product offers a new therapy for heart failure patients with reduced ejection fraction.

Businesswire 12.10.19

Former Executives, Employees of Health Technology Startup Charged in $1 Billion Fraud Scheme

Federal government claims workers falsely represented revenue for additional profit.

U.S. Department of Justice 11.26.19

Miles D. White to Step Down as Abbott CEO

Current president and COO Robert B. Ford, a 23-year Abbott veteran, will succeed White as CEO.

PR Newswire 11.13.19

Patient Monitoring

Philips Debuts Vital Signs Monitor for Early Patient Intervention in General Care Setting

Early Warning Scoring, predictive trend analytics, and intelligent algorithms help detect patient deterioration earlier to enable timely intervention.

GlobeNewswire 11.05.19

Packaging & Sterilization