Medical device companies play an essential role in combatting the novel coronavirus (COVID-19). To help, MD+DI is tracking developments in evolving regulator policies, support from medtech suppliers, and the progress being made in meeting urgent needs for medical supplies. Click on the links below for details, and monitor this page for updates.

Regulations, Policies, and Government Response
Feds Take Pandemic Profiteering Seriously
FDA Warns of COVID-19 Antibody Testing Limitations
3D Printing of PPE and Other Medical Devices
A Comprehensive Guide to COVID-19 EUA Submissions
How CDRH Is Responding to COVID-19
Proposal to Postpone EU Medical Device Regulation Underway
FDA Warns Against Fraudulent COVID-19 Tests and Treatments
FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices
FDA Issues Enforcement Policy for Ventilators Amid Shortage Concerns
U.S. Government Issues RFI for Solutions to Combat Coronavirus (COVID-19)
FDA Gives EUA to CDC Coronavirus Detection Test
FDA Lays Out Plan for Coronavirus Medical Countermeasures

Supplier Support
Supplier Stories for the Week of April 12: Carbon, Arburg, FLIR Systems, WAI
Supplier Stories for the Week of April 5: Polyzen Inc., Tessy Plastics Corp., SpotSee, Walki, KOGANEI International America Inc., Placon, NiceLabel, Solvay, Qosina, SABIC, Chamfr, and Fictiv
Supplier Stories for the Week of March 29: Esys Automation, a JR Automation; Delve; IMI Precision Engineering; Primex Plastics Corp.; and Specialty Silicone Products (SSP)
Battelle Earns FDA EUA for Decontaminating Respirator Masks
Formlabs Is 3D Printing More than 100,000 COVID-19 Test Swabs Daily
Respira Next Generation Personal Protective Equipment Mask: HS Design
Thermoformer Develops Face Shields Needed in COVID-19 Pandemic: Prent Corp.
Supplier Stories for the Week of March 22: Web Industries, Smalley, Sensirion, Qosina, and Bindatex
Supplier Stories for the Week of March 15: Nelson Laboratories
Virtual Medical Device Meetings You Need to Know About: Nanofabrica
How 3D Printing Is Helping in the Fight Against Coronavirus

Medtech’s Response
Employing AI and Remote Patient Monitoring in the Fight Against COVID-19
FDA Grants EUA for LabCorp’s At-Home COVID-19 Test
FemtoDx Working to Develop Rapid At-Home COVID-19 Test
Single-Use Bronchoscopes Could Reduce Contamination Risks During COVID-19 Pandemic
Saliva Used to Monitor Glucose Levels?
How Abbott Became a Leader for COVID-19 Testing
Lab Validates Use of Co-Diagnostics's Covid-19 Test on Saliva Samples
Ortho Clinical Diagnostics Picks up EUA for COVID-19 Total Antibody Assay
Device to Assist in Weaning Patients Off Ventilators is Granted EUA
FDA Grants EUA to First Saliva-Based Coronavirus Test
AI-Powered CT Imaging System Shown to Detect COVID-19
It's Not Just Diabetes Patients Who Need Glucose Monitoring During This Pandemic
Several Telemedicine and Remote-Patient Monitoring Solutions Cutting Through the COVID-19 Clutter
How CGM Systems Are Joining the COVID-19 Fight
How to Service Essential Medical Equipment During a Pandemic
Luminex Gains EUA for Diagnostics as Demand for COVID-19 Tests Soars
Siemens Developing New Diagnostic for COVID-19
Healthcare Tech Company Nets $13M for Faster, More Accessible COVID-19 Test
S+N Lands Contract to Produce OxVent Ventilators on a Large Scale
Abbott Brings Rapid Testing to the Front Lines
Medtronic Shares Ventilator Design Amid Shortage Concerns
New York Times Article on Failed Ventilator Program Triggers a Response from Medtronic
Thermo Fisher Granted CE Mark for COVID-19 Test
Astrotech Developing New Test for COVID-19
Masimo’s Latest Acquisition Could Help in the Fight Against COVID-19
Abbott Brings Home EUA for COVID-19 Test
Rapid Diagnostics Firm Secures Financing Amid Covid-19 Crisis
BD Ramps Up Production, Collaborates on New Diagnostic in Response to COVID-19
Can Remote Patient Monitoring Curb COVID-19?
Medical Equipment Manufacturer Increases Production to Meet Demand Driven by COVID-19 Pandemic
More Tests on the Way as Coronavirus Spreads
Researchers Discover Interesting Imaging Features for Coronavirus
Co-Diagnostics Grabs CE Mark for Coronavirus IVD
8 Ways the Medtech Industry is Responding to the Coronavirus

Market Impact
Dexcom Patients Will Have Longer Wait for G7 as COVID-19 Disrupts Pivotal Trial
Second Sight Gives Clearer Picture of Strategy Going Forward
Volunteer Efforts Vet N95 Cleaning Methods
Is Medtech Prepared for Recovery?
Medtech Perseveres During COVID-19
Conformis Gets Some Economic Relief to Help with Negative COVID-19 Impact
Can Intuitive Surgical Continue to Rise Above COVID-19 Disruptions?
COVID-19 Business Updates Provide Some Clarity
Telemedicine Is Here to Stay
Ventilator Supply Numbers a Very Quickly Moving Target
GenMark Diagnostics Sees 80% Revenue Boost in First Quarter
More Medical Device Businesses Impacted by COVID-19
Boston Scientific Cuts Pay and Withdraws Revenue Guidance
COVID-19 Could Hurt Orthopedics Companies in More Ways than One
Is Second Sight Closing up Shop?
Quarantined Physician Waiting on COVID-19 Test Results for Nearly 2 Weeks
Obalon Mulling Over Strategic Options Amid COVID-19 Crisis
How Is COVID-19 Impacting Organ Transplants?
Conformis Faced with Tough Decision to Furlough One-Third of Its Workforce
The Biggest Threat to Medical Device Revenue Growth During the Pandemic
FDA Suspends Inspections Outside of the US Due to Coronavirus Outbreak
Coronavirus Hits Big Medtech Where It Hurts Most – Revenue

Other Innovations
Rushing Supplies to the COVID-19 Forefront
Apple Jumps into COVID-19 Fight with New Screening Tool
Elon Musk Talks Ventilators with Medtronic
Virginia Boy 3D Prints Mask for Sick Uncle and Others