Medical Product Outsourcing

Mike on Medtech: Biocompatibility and Nitinol Guidances

Mike Drues and Sean Fenske discuss two FDA guidance documents that focus on biocompatibility and nitinol-containing devices.

Sean Fenske, Editor-in-Chief 10.26.20

MedCrypt Acquires MedISAO, Addressing FDA Premarket and Postmarket Guidances

The deal establishes the implementation standard for medical device security.

PR Newswire 10.06.20

Cardiovascular | Surgical

FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System

Allows electrophysiologists to visualize 3D electroanatomic models in real-time, via a wearable headset.

PR Newswire 09.30.20

Medtech’s Battle on Multiple Fronts Against COVID-19

From PPE to testing to ventilator solutions, medtech firms are trying to find answers for healthcare’s needs against the novel coronavirus.

Online Exclusives Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20

Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts

Tests will aid in responsible back-to-work assessment, according to manufacturer.

Ortho Clinical Diagnostics 04.27.20

MDR Delay Official; Industry Urges Push Back of IVDR

European Council voted 27-0 to adopt amendment delaying MDR application by one year due to COVID-19 pandemic.

MedTech Europe 04.24.20

Patient Monitoring | Surgical

Brainlab's ExacTrac Dynamic Patient Positioning, Monitoring Gains CE Mark

New 4D thermal surface tracking combined with flagship X-ray technology increases versatility.

Business Wire 04.21.20

Diagnostics

FDA Update: COVID-19 Antibody Test Validation and Education

Results from these tests can help identify who has been infected and developed antibodies.

U.S. Food and Drug Administration 04.20.20

Baxter’s Q1 Earnings Forecasted to Increase, GlobalData Says

Job postings triple as demand increases.

GlobalData 04.17.20

FDA Continues User-Fee Related Reviews Through COVID-19

FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.

U.S. Food and Drug Administration 04.17.20

FDA OKs B. Braun Infusion Pumps with Nebulizers to Treat COVID-19

Pumps to be used for tracheal delivery of continuous nebulized medications into a nebulizer.

PR Newswire 04.14.20

Non-Invasive Ventilators Offer Life-Saving Treatment for Less Severe COVID-19 Patients

Manufacturers could produce more than 60,000 per week, easing pressure on the system.

AdvaMed 04.09.20

MedLite ID Appoints New Board Chairman, COO/CFO

Company founder is associated with over 100 patents ranging from mechanical devices, dental products, medical devices, and medical software products.

PR Newswire 04.08.20

Zimmer Biomet CEO Foregoing Salary During COVID-19 Crisis

Bryan Hanson's salary forfeit is among many steps the company is taking to contain costs amid the pandemic.

Zimmer Biomet 04.07.20

Foster Corporation, LioChem Expand Medical Color Masterbatch Capability

Lioplax MD color masterbatch products, capability, and expertise will allow Foster to offer increased service levels and larger order capabilities.

Foster Corporation 04.07.20

Cardiovascular

ExThera’s Blood Filter Treats COVID-19 Patients in Europe

Treatments are expected to begin in the U.S. soon.

ExThera Medical 04.06.20

Diagnostics

COVID-19 Patients Being Triaged, Assessed Using Two-Minute Breath-Based Gas Test

The MediPines AGM100's breathing gas-based measurement can provide immediate respiratory data after the patient breathes into a breathing tube.

PR Newswire 04.06.20

Diagnostics

Researchers Validate Viability of Saliva in COVID-19 Detection

Saliva testing allows for simple self-administered sample collection that even those in quarantine or self-isolation can use.

Spectrum Solutions LLC 04.03.20

The U.S. May Not Be Able to Purchase More N95 Respirators from 3M

According to GlobalData, 3M may have lost control of its distributor system.

GlobalData 04.03.20

Johnson & Johnson Pauses 2020 Medical Devices Business Review

Coronavirus outbreak postpones review planned to take place March 13.

PR Newswire 04.02.20

Circadia Health Commits $3 Million in Respiratory Monitors to Combat COVID-19

Effort is in response to FDA’s latest guidance to expand the availability and capability of non-invasive remote respiratory monitoring devices.

Globe Newswire 04.02.20

R&D & Design

Examining the Usability of Medical Software

Developers need to consider the ‘human factor’ when it comes to testing medical device software.

Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20

Software & IT

Validating Your QMS the ‘EZ Way’

Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.

James Shore and Roxana Rosales 04.01.20

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

Diagnostics

Gaining a Clearer Picture of Hitachi

Diagnostic imaging is gaining the attention of many in healthcare as the technologies shrink in size and become available to those outside the hospital.

Sean Fenske, Editor-in-Chief 04.01.20

R&D & Design

Top 10 Considerations for Medtech Inventors

If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.

Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20

The Economics of a Sound Regulatory Strategy

While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.

Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20

COVID-19’s Impact on the Medical Device Supply Chain

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Tony Freeman, President, A.S. Freeman Advisors LLC 04.01.20

Diagnostics

BD, BioMedomics Launch Test to Detect Exposure to COVID-19

Point-of-care blood test detects evidence of present or past exposure in 15 minutes.

BD 03.31.20

R&D & Design

Rice Joins U of U-Led Human Factors Consortium

Brings new expertise to the consortium, led by University of Utah.

University of Utah 03.30.20

Medtronic Shares Ventilator Design Specifications

The company aims to accelerate efforts to increase global ventilator production amid COVID-19.

Medtronic 03.30.20

FDA Takes Action to Increase U.S. Ventilator, Respirator Supply

Certain ventilators and machines modified for use as ventilators granted emergency use authorization.

U.S. Food and Drug Administration 03.30.20

Advanced Sterilization Products Extends the Lifespan of N95 Masks

ASP qualified a protocol for reprocessing select N95 masks so hospitals can triple the lifespan of the mask using the Sterrad Sterilizers.

Advanced Sterilization Products 03.30.20

Philips to Assess PCI Outcomes Using Integrated iFR Technology

Global multi-center study will compare outcomes between physiological guidance by iFR data co-registered on the angiogram vs. angiogram alone.

Royal Philips 03.27.20

FDA Releases Face Mask, Respirator Enforcement Policy for COVID-19 Pandemic

Aims to expand general use face masks for the public, and filtering respirators for healthcare professionals.

U.S. Food and Drug Administration 03.26.20

Nu-Med Plus Monitoring Outcomes on COVID-19 Treatment Trials

Inhaled nitric oxide has been used in the past as a supportive measure in treating coronavirus-infected patients.

Globe Newswire 03.25.20

Cardiovascular | Patient Monitoring

FDA OKs AliveCor's KardiaMobile 6L to Measure QTc in COVID-19 Patients

Monitors QT duration in patients receiving medications that can cause potentially life-threatening QT prolongation.

PR Newswire 03.24.20

Digital Health

MobileSmith Health's Mobile Apps Support Hospital Response to COVID-19

Apps allow hospitals to share reliable, accurate information on the coronavirus pandemic with the community, hospital employees, and volunteers.

Globe Newswire 03.24.20

Diagnostics

UC San Diego Partners with 5 Dx Manufacturers to Boost COVID-19 Testing

The University is working with Thermo Fisher, Roche, GenMark, Luminex, and Abbott.

University of California - San Diego 03.23.20

FDA Relaxes Ventilator Oversight in Effort to Boost Supply

The measure will help expand the availability of devices that facilitate respiration, including ventilators and accessories during pandemic.

U.S. Food and Drug Administration 03.23.20

Diagnostics

FDA-Cleared Blood Test Used to Guide COVID-19 Treatment

The Daxor test has been shown to reduce ICU mortality by as much as 66%.

Globe Newswire 03.20.20

Patient Monitoring

FDA Expands Use of Remote Vital Signs Monitoring Devices

These devices provide crucial information when diagnosing or treating COVID-19 or co-existing conditions.

U.S. Food and Drug Administration 03.20.20

R&D & Design

Pediatric Medical Device Pitch Competition Announces 30 Semi-Finalists

Thirty innovators will compete on March 23, 2020 in a virtual showcase.

National Capital Consortium of Pediatric Device Innovators 03.19.20

Patient Monitoring

Medicare Telehealth Benefits Expanded During COVID-19 Outbreak

Beneficiaries can receive common office visits, mental health counseling, and preventive health screenings remotely.

Centers for Medicare & Medicaid Services 03.18.20

Diagnostics

New COVID-19 Diagnostic Test Could Confirm Virus in Under One Hour

The test may be able to confirm the SARS-CoV-2 virus at the point of care (patient's bedside).

PR Newswire 03.17.20

Diagnostics

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

Diagnostics

Avellino Labs Launches FDA-Recognized COVID-19 Test

Test uses the company’s existing genetic diagnostics platform.

Business Wire 03.09.20

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