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Featured Stories


‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made Ventilators Could Portend Product Problems

Two former US FDA officials tell Medtech Insight they’re concerned about product problems down the line as automobile manufacturers make critically needed medical ventilators amid the COVID-19 crisis, and as other device makers quickly scale up manufacturing on items like masks and gowns. Compounding problems is the agency’s decision to stop conducting quality systems inspections at facilities in the US and China.

Manufacturing Safety Quality

Becton Dickinson, BioMedomics Collaborate On Rapid Serology COVID-19 Test

BD and BioMedomics have released a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.

Approvals Coronavirus COVID-19 Infectious Diseases

FDA Open To Home COVID-19 Testing With Caveats, OIVD’s Stenzel Says; Grants First Serology Test EUA To BD

The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health. Stenzel also heralded the FDA’s first emergency use authorization for a coronavirus serology test, which was granted to diagnostic developer Becton Dickinson.

Policy Coronavirus COVID-19 FDA

Grail’s Liquid Biopsy Can Detect Numerous Deadly Cancer Types Early

Grail announced results from an initial validation study that showed its early-detection blood test could identify 12 of the deadliest cancers with a low rate of false-positive results.

Cancer Clinical Trials Digital Health

UK Waives Import Taxes On COVID-19 Products

Suppliers to the UK’s National Health Service from outside the EU could save up to 12% in costs for some equipment during COVID-19 emergency measures as the UK tries to increase supplies

Europe EU Medical Device

Industry Asks If Small Business Loan Relief Applies To Companies With Equity Investors

A medtech industry group is asking the Trump administration to clarify if small medical device companies that have equity investors qualify for small business loans and forgiveness under the coronavirus relief package.

Policy Commercial Coronavirus COVID-19

Countdown to EU MDR

 
The EU Medical Device Regulation comes into force on 26 May. Click here to read more.
 

Latest from PR Newswire

Click here to access further medical device and diagnostics news.
 


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Policy & Regulation Explore this Topic

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What COVID-19? FDA’s CDRH Sets June In-Person Meeting For Eye Implant Device

The US agency’s Center for Devices and Radiological Health is assembling an in-person advisory committee meeting in early June, the first since the COVID-19 pandemic began. The goal is to discuss the approval of an implant device to treat the natural aging of the eye.

Regulation Commercial Advisory Committees

US VP And CMS Chief Urge In-House Academic Hospital Labs To Share COVID-19 Data With HHS

US Vice President Mike Pence and Medicare administrator Seema Verma want academic and university hospital laboratories to send their de-identified COVID-19 test data results, daily, to the Department of Health and Human Services. Commercial and private labs are exempt from the request, as they already share their coronavirus test results with the government.

Policy Coronavirus COVID-19 Medicare

Warning Letter Roundup & Recap – 31 March 2020

No device-related warning letters were released by the US FDA the week of 31 March.

Device Warning Letters FDA

COVID-19: Medtronic Shares Ventilator Specs Amid Multi-Industry Efforts To Increase Ventilator Production

Medtronic shares an open-source design for its ventilator to help mitigate the nation’s ventilator shortage for COVID-19 patients.

Coronavirus COVID-19 Safety

UK MHRA To Medtech: Check Before Applying For Non-COVID-19 Trials

The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these. 

Coronavirus COVID-19 Clinical Trials

Belgium Bans COVID-19 Antibody Self-Tests But UK Goes Ahead

While the UK is moving forward quickly to provide COVID-19 antibody self-testing, the Belgian government considers the tests not sufficiently accurate to be used in the pandemic.

Medical Device Europe

QUOTED. 31 March 2020. US FDA.

The US FDA published on 29 March an emergency temporary guidance that relaxes oversight of certain sterilizers, disinfectant devices and air purifiers intended to kill the SARS-CoV-2 virus. See what the agency said about it here.

Quoted Regulation

FDA To Relax Some Standards For Use Of Surgical Gowns, Gloves, Other Apparel During COVID-19 Crisis

The US FDA wants to expand the availability of surgical apparel – including gowns, hoods and examination gloves – for health care professionals to use for the duration of the COVID-19 public health crisis. That means the agency will “not object” to the use of gowns and gloves providing low-to-minimal protection, as long as they do not create an undue risk to patients or users.

Enforcement Policy

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Quality Should Ride Shotgun As US Auto Makers Rev Engine On Making Ventilators

As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.

Quality Manufacturing

COVID-19 May Delay WHO’s Prequalification Of Devices, IVDs

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

Quality Safety

COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators

The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.

United States Quality Control

Commercial Explore this Topic

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Execs On The Move: New Global Comms Boss At Siemens; CRH CEO Now Also Chair; New CEO At ChroniSense Medical

German multinational firm Siemens picks a global communications head; CRH Medical CEO also takes on chairmanship; ChroniSense Medical, a developer of medical monitoring devices, hires a new CEO; and more.

Commercial Appointments Medical Device

Latest From Commercial

QUOTED. 1 April 2020. Bob White.

Medtronic is publicly sharing design specifications for its PB 560 ventilator to help the global multi-industry effort devise options for rapid ventilator manufacturing. See what Bob White, president and executive VP for Medtronic’s Minimally Invasive Therapies Group, said about it here.

Quoted Coronavirus COVID-19

COVID-19: Medtronic Shares Ventilator Specs Amid Multi-Industry Efforts To Increase Ventilator Production

Medtronic shares an open-source design for its ventilator to help mitigate the nation’s ventilator shortage for COVID-19 patients.

Coronavirus COVID-19 Safety

MiDiagnostics Raises €14M For ‘Lab On A Chip’ Blood Test Tech

Belgian start-up miDiagnostics has closed a €14m investment round to accelerate development of its silicon-chip-based diagnostics platform. The company believes the blood analyzer could deliver rapid test results in multiple settings.

Diagnostics Financing

In A Bizarre Move, Trump Orders GM To Make Ventilators – Even Though The Auto Giant Already Is

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.

Coronavirus COVID-19 Manufacturing

Start-Up Spotlight: Iraq War Veteran Deploys ‘Bone Paint’ To Combat Traumatic Injuries

Theradaptive's “paint-like” regenerative therapeutic can be applied to any device to promote bone regrowth or regenerate tissue.

Commercial Innovation

COVID-19: FDA Offers Cautionary FAQs On 3D Printing Of Key Medical Supplies

In a 28 March FAQ document, the US agency cautions manufacturers on the 3D printing of medical devices to address the shortage of ventilators and other medical supplies during the coronavirus pandemic.

Coronavirus COVID-19 FDA

Clinical R&D Explore this Topic

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ACC 2020: SPYRAL HTN-OFF MED Results Support Medtronic’s Renal Denervation System

Three-month results of the SPYRAL HTN-OFF MED pivotal trial show renal denervation with Medtronic’s Symplicity Spyral system significantly reduced blood pressure in hypertensive patients not taking anti-hypertensive medications.

Clinical Trials Innovation Cardiovascular

Latest From Research & Development

QUOTED. 1 April 2020. Bob White.

Medtronic is publicly sharing design specifications for its PB 560 ventilator to help the global multi-industry effort devise options for rapid ventilator manufacturing. See what Bob White, president and executive VP for Medtronic’s Minimally Invasive Therapies Group, said about it here.

Quoted Coronavirus COVID-19

COVID-19: Medtronic Shares Ventilator Specs Amid Multi-Industry Efforts To Increase Ventilator Production

Medtronic shares an open-source design for its ventilator to help mitigate the nation’s ventilator shortage for COVID-19 patients.

Coronavirus COVID-19 Safety

Approval Of Medtronic’s Renal Denervation System Delayed By COVID-19

Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.

Clinical Trials Coronavirus COVID-19

COVID-19 Raises Demand For Butterfly's Single-Probe Ultrasound System

Butterfly Network is disseminating the lessons from China and Italy about the poential value of lung ultrasound in the management of COVID-19 patients with respiratory disease.

Coronavirus COVID-19 Clinical Trials

Abbott Launches Five-Minute POC Rapid COVID-19 Test

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

Coronavirus COVID-19 Approvals

More Than Hot Air: Dyson Wins UK Order For New CoVent Ventilator

UK engineering firm Dyson, best known for its vacuum cleaners, fans and hand driers, plans to make 10,000 specially designed ventilators under a UK government contract.

United Kingdom Coronavirus COVID-19
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