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‘Hunker Down, Expect The Worst And Hope For The Best’: Investment Analyst Advises Medtech Businesses To Cut Costs

Maxim Jacobs, managing partner at Edison Investment Research, urges medtech companies to be financially prudent as the COVID-19 pandemic worsens. Cancellations of routine surgeries are creating a huge strain on device businesses which could continue for months.

Analysis Commercial Companies

COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps, ECMO Devices, Thermometers, And More

In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.

FDA Guidance Documents Coronavirus COVID-19

COVID-19: ResMed Ramps Up CPAP, BPAP Manufacturing To Address Ventilator Shortage

ResMed plans to double or even triple production of intensive ventilators and sleep apnea machines this year amid rising demand by hospitals to use CPAP and BPAP machines to treat COVID-19 patients during the ventilator shortage. 

Coronavirus COVID-19 Respiratory Infectious Diseases

Trump Pushes Back On OIG Report That Hospitals Want Feds To Better Police Resources, Relax Regs

When asked about an inspector general report that found hospitals are struggling with tests and resources, and are looking to the federal government to help facilitate more efficient distribution of medical devices to fight the COVID-19 crisis, President Trump attacked the report as a political hit from an Obama holdover.

Regulation Coronavirus COVID-19 Approvals

US Medicare Agency Alters Payments For Use Of Telehealth Tech, Lab Specimen Collection For COVID-19

An interim final rule posted by the CMS this week widens further a series of telehealth exemptions and lab specimen collection payment provisions it has previously issued to help providers during the COVID-19 pandemic.

Policy Coronavirus COVID-19 Medicare

New EU Rules Allow Buyers To Procure COVID-19 Devices ‘Within Hours’

With hospitals throughout the EU short of urgently needed COVID-19 medical supplies, including respiratory equipment, there are ways for companies to sell and deliver their products quickly.

Medical Device Europe EU

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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Commission Provides Regulatory Advice For COVID-19 Medtech Sector Entrants Amid Counterfeit Concerns

A new European Commission guidance document explains the regulatory basics and emergency market entry criteria for new entrants to the devices sector amid the COVID-19 crisis.

Medical Device Europe EU

Manpower Not Materials Could Hold German COVID-19 Testing Back

Lab testing for COVID-19 has risen to a new high of 314,000 tests per week in Germany, where the concerns are perhaps less about test availability than staff numbers to oversee the testing protocols.

Germany Coronavirus COVID-19 Policy

MDR Delay: Is It All Good News Or Does It Bring Its Own Problems?

In responding to industry’s plea for more time to comply with the EU’s MDR, the European Commission’s proposed one-year delay may also create some unwelcome repercussions for manufacturers and notified bodies.

EU Europe

QUOTED. 8 April 2020. Carlos Nunez.

ResMed plans to double, even triple its production of ventilators, CPAP and BPAP machines to help fight the shortage of life-saving ventilators to treat COVID-19 patients. See what ResMed’s chief medical officer, Carlos Nunez, said about the company’s supply chain.

Quoted Respiratory

COVID-19: WHO Supports Pooling Of Rights, MPP Includes Drugs and Tests

Intellectual property rights are in the spotlight again, after the World Health Organization and the Medicines Patent Pool announced initiatives to help ensure that all countries will be able to access products being developed for COVID-19.

International Coronavirus COVID-19

Notified Body Expert Akra Calls For Special Taskforce Measures To Oversee New COVID-19 Products

With many non-CE marked products being allowed onto various EU member state markets, who is going to monitor compliance? TÜV-SÜD’s Bassil Akra calls for cooperation to avoid unsafe products being used on patients.

Europe EU

QUOTED. 7 April 2020. Surendar Magar.

California-based biosensor patch company LifeSignals Group plans to file for an emergency use authorization from the US FDA for a new patch that can monitor vital signs to help individuals decide when to seek the help of a health care provider. See what LifeSignals’ CEO Surendar Magar said about it here.

Quoted Coronavirus COVID-19

Warning Letter Close-Outs – March 2020

The US FDA released five device-related close-out letters in March.

Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

Warning Letter Close-Outs – March 2020

The US FDA released five device-related close-out letters in March.

Device Warning Letters FDA

As China Rushes Medical Supplies To World, Quality Issues Resurface

As China is poised to supply medical products to fight the coronavirus around the world, a battle to banish its image of poor product quality is on.

Quality Regulation

‘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

Commercial Explore this Topic

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

BD and BioMedomics will soon begin distributing 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

Latest From Commercial

QUOTED. 8 April 2020. Carlos Nunez.

ResMed plans to double, even triple its production of ventilators, CPAP and BPAP machines to help fight the shortage of life-saving ventilators to treat COVID-19 patients. See what ResMed’s chief medical officer, Carlos Nunez, said about the company’s supply chain.

Quoted Respiratory

Execs On The Move: Promotions Are In The Spotlight At Terumo And MiMedx Group

Japanese medical device manufacturer Terumo Corp. promoted senior management execs; MiMedx Group, developer of human placental tissue allografts, raised exec to CFO; and more.

Commercial Appointments

QUOTED. 7 April 2020. Surendar Magar.

California-based biosensor patch company LifeSignals Group plans to file for an emergency use authorization from the US FDA for a new patch that can monitor vital signs to help individuals decide when to seek the help of a health care provider. See what LifeSignals’ CEO Surendar Magar said about it here.

Quoted Coronavirus COVID-19

QUOTED. 6 April 2020. Bethany Hills.

Diagnostics company Bodysphere had to retract an announcement that it had received an emergency use authorization from the US FDA for a COVID-19 serologic test. See why Bethany Hills, an attorney with law firm Morrison & Foerster, says this may be a cautionary tale for other manufacturers.

Quoted Regulation

QUOTED. 3 April 2020. Minetta Liu.

Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.

Quoted Clinical Trials

LifeSignals Plans To Market Biosensor Patch To Help Consumer Identify COVID-19 Symptoms

LifeSignals plans to soon launch a biosensor patch to consumers to help them monitor for potential symptoms of COVID-19. 

Coronavirus COVID-19 Digital Health

Clinical R&D Explore this Topic

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ACC 2020: TAVR Matches Surgery In Two-Year PARTNER 3 Results

The two-year results from the PARTNER 3 trial showed transcatheter aortic valve replacement with Edwards Lifesciences' Sapien 3 system was statistically non-inferior to surgical valve replacement in low-risk patients. The one-year results from the trial had shown TAVR was superior to surgery in low-risk patients.

Clinical Trials Research & Development Cardiovascular

Latest From Research & Development

QUOTED. 7 April 2020. Surendar Magar.

California-based biosensor patch company LifeSignals Group plans to file for an emergency use authorization from the US FDA for a new patch that can monitor vital signs to help individuals decide when to seek the help of a health care provider. See what LifeSignals’ CEO Surendar Magar said about it here.

Quoted Coronavirus COVID-19

Device Week, April 3, 2020 – New Telemonitoring Patch; Medtronic Delays Renal Denervation Approval

In this edition of the Device Week podcast, Medtech Insight managing editor Marion Webb discusses LifeSignals’ plans for a vital-sign monitoring patch that could help remotely monitor patients during the pandemic. Deputy editor Reed Miller highlights some important device trials presented at the American College of Cardiology online conference.

Device Week Clinical Trials

QUOTED. 3 April 2020. Minetta Liu.

Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.

Quoted Clinical Trials

LifeSignals Plans To Market Biosensor Patch To Help Consumer Identify COVID-19 Symptoms

LifeSignals plans to soon launch a biosensor patch to consumers to help them monitor for potential symptoms of COVID-19. 

Coronavirus COVID-19 Digital Health

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

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 Research & Development
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