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FDA Increases Premarket Application Fees Again This Year, But Not By As Much

Fees for filing a premarket application with the US FDA increased 2.5% for fiscal year 2022, which is significantly less than the 7% they went up last year. 

FDA User Fees Review Pathway

Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections

Former US FDA device center compliance chief Steve Silverman argues in this opinion piece that the agency and stakeholders should take steps now to develop a remote-inspection framework for medical device manufacturers.

FDA Enforcement Coronavirus COVID-19

FDA Warning Letter Recap, July 2021: Device Center Brings Hammer Down On Face Mask Vendors

The US FDA says the 11 companies were selling masks without agency clearance, approval or authorization. A total of 13 device-related missives were released by the FDA in July.

Device Warning Letters FDA Enforcement

Handheld Ultrasound Developer Exo Raised $220M In Series C

As Exo awaits FDA clearance for its handheld ultrasound device, it will use the new funding for planned commercialization. Exo has raised more than $320m to date. 

Financing Diagnostic Imaging Digital Health

Warning Letter Close-Outs – July 2021

The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.

Device Warning Letters FDA Enforcement

Intuitive Fights Da Vinci Surgical Robot Monopoly Claims

Intuitive Surgical is facing multiple antitrust suits that say the company took advantage of its dominant market position by demanding hospitals come to it for expensive repairs and replacements.

Robotic Surgery Legal Issues Commercial

QUOTED. David Stein.

Babson Diagnostics recently raised $31m to accelerate commercialization of its blood testing “ecosystem.” CEO David Stein discussed the potential of the technology.

Quoted Digital Health Consumer

Device Week Podcast


In This Episode:

Latest Physician Fee Schedule Proposal Could Impact Companies’ Bottom Line

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

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Policy & Regulation Explore this Topic

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NHS England: Can Stevens’ Legacy Be Bettered As Health Care Transformation Gains Pace?

Sir Simon Stevens leaves his position as chief executive of NHS England at the end of July after seven years of probably unmatched achievement. His will be big shoes to fill by Amanda Pritchard, his erstwhile deputy.

United Kingdom Policy Medical Device

Many Device-Related Deaths Are Not Being Accurately Reported To FDA, Study Claims

Research from the University of California, San Francisco claims that many deaths involving medical devices are incorrectly reported to the US agency, and says improving the accuracy of how these deaths are classified could improve patient safety.

FDA Safety Quality Control

Latest From Policy & Regulation

FDA Grants Labelers Of Lower-Risk Devices More Time To Comply With UDI Reg

Labelers of an array of medical devices, from contact lenses to condoms, have been given more time to comply with the US FDA’s eight-year-old Unique Device Identification rule. The agency says labelers of certain products may continue using Universal Product Codes (UPCs) on packaging through September 2023.

FDA Regulation

COVID-19: FDA Schedules 4 More Virtual Town Halls Through August

The US agency has announced four additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.

Diagnostics FDA

Exec Chat: New CEO Of Digital Therapeutics Alliance Says Reimbursement Remains Big Issue

In an interview with Medtech Insight, Andy Molnar, new CEO of the Digital Therapeutics Alliance, outlines some of the big issues facing the digital therapeutics industry, which has seen tremendous growth during the pandemic.

Exec Chat Digital Health

CDC To Yank EUA On Original COVID-19 Test At Year’s End

The US body says it wants to encourage labs to use newer, faster alternatives that can also detect other pathogens.

Coronavirus COVID-19 Review Pathway

Device Week, 28 July 2021 – US Medicare Reimbursement News And A Roundup Of UK Regulatory Changes

On this week’s podcast we highlight US Medicare reimbursement topics that industry should keep an eye on, and discuss important regulatory changes underway in the UK.

Device Week Policy

Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips

Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.

Regulation Respiratory

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

FDA Grants Labelers Of Lower-Risk Devices More Time To Comply With UDI Reg

Labelers of an array of medical devices, from contact lenses to condoms, have been given more time to comply with the US FDA’s eight-year-old Unique Device Identification rule. The agency says labelers of certain products may continue using Universal Product Codes (UPCs) on packaging through September 2023.

FDA Regulation

How To Comply With New Requirements For Companion Diagnostics Under IVDR

The regulation of companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.

EU Europe

Notified Bodies Urge Companies To Pay Attention To Vague Implant Card Rules

Due to a lack of clarity in the MDR wording around which devices should be accompanied by implant cards, there is a risk companies may not supply them when patients would benefit. TEAM-NB offers guidance.

EU Europe

OUTLOOK 2021

Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings

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Commercial Explore this Topic

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Babson Diagnostics Plans To Deliver What Theranos Could Not

Babson recently raised $31m to accelerate commercialization of its blood testing “ecosystem,” developed with help from Siemens Healthineers and Becton Dickinson.

Digital Health Diagnostics Consumer

Latest From Commercial

Signifier Medical Technologies Raises $35M In Series D

The UK-based company said it will use the new funding to advance commercialization of its daytime treatment for mild sleep apnea and snoring.

Financing Digital Health

LinkDoc’s US Listing In Jeopardy Following China's New Data Security Requirements

The US listing of Chinese artificial intelligence, medical records and patient management system company Linkdoc could be derailed, after China issued new data review requirements tightening the oversight of overseas listings of domestic companies.

China Commercial

Exec Chat: New CEO Of Digital Therapeutics Alliance Says Reimbursement Remains Big Issue

In an interview with Medtech Insight, Andy Molnar, new CEO of the Digital Therapeutics Alliance, outlines some of the big issues facing the digital therapeutics industry, which has seen tremendous growth during the pandemic.

Exec Chat Digital Health

Kaia Health Publishes Study Showing Digital Physical Therapy Corrections On Par With Human Therapist

Kaia Health published a study suggesting its digital physical therapy is not inferior to seeing a physiotherapist. Digital app makers focusing on rehabilitating musculoskeletal conditions have seen significant growth during the pandemic.

Digital Health Artificial Intelligence

First Test That Predicts Severe Outcomes In COVID-19 Patients Receives CE Mark

MeMed’s test measures immune system response to assess a patient’s COVID-19 trajectory.

Coronavirus COVID-19 Approvals

Abbott’s Q2 Medical Device And Diagnostic Sales Surpass 2019 Levels

Abbott expects the ongoing recovery of medical procedure volumes to continue even as new virus variants are causing COVID-19 cases to increase in some geographies.

Sales & Earnings Coronavirus COVID-19

Clinical R&D Explore this Topic

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Inspira Goes Public To Develop Its Alternative To Mechanical Ventilation

The Israeli company raised $16m to support its Augmented Respiration Technology, a novel approach for delivering oxygen directly into the venous system. The company expects to earn FDA clearance for first product by 2023.

Respiratory Financing Innovation

Latest From Research & Development

Signifier Medical Technologies Raises $35M In Series D

The UK-based company said it will use the new funding to advance commercialization of its daytime treatment for mild sleep apnea and snoring.

Financing Digital Health

Kaia Health Publishes Study Showing Digital Physical Therapy Corrections On Par With Human Therapist

Kaia Health published a study suggesting its digital physical therapy is not inferior to seeing a physiotherapist. Digital app makers focusing on rehabilitating musculoskeletal conditions have seen significant growth during the pandemic.

Digital Health Artificial Intelligence

Happify Health Launches Prescription Digital Therapeutics To Treat Depression Or Anxiety

After raising $73m in a series D in March, Happify Health is recruiting patients in a real-world study to further evaluate its behavioral health app.

Digital Health Neurology

Digital Health Roundup, June 2021: Winners In Record-Breaking H1 Digital Health Funding; ADA 2021; Telehealth Update

In this roundup feature focusing on the developments in digital health, we highlight the key news and announcements from June.

Digital Health Telehealth

Ancora Heart Raises $80M To Support Ongoing Trial To Treat Heart Failure Patients

Ancora Heart will use the new funding to accelerate its pivotal trial of the AccuCinch ventricular restoration system for treating heart failure patients with reduced ejection fraction.

Cardiology Financing

Foundation Medicine Obtains FDA Approval For Non Small Cell Lung Cancer Companion Diagnostic

Foundation Medicine and Novartis’ commercial partnership has achieved another success as Foudation’s Liquid CDx is approved.

In Vitro Diagnostics Cancer
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