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Featured Stories



COVID-19 Shows Remote Monitoring Can Work For Pre-Cert Program

In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.

Regulation Artificial Intelligence Coronavirus COVID-19

Novocure Transforms Patient Support System During Pandemic

The company is running a pilot program to allow glioblastoma patients who use Novocure’s Optune Tumor Treating Fields device to download data from the device at home.

Business Strategies Telehealth Cancer

Amwell Stock Rises 28% In Market Debut

Amwell’s increased the size of its IPO and raised $742m when it sold 41.2 million shares at $18 each.

Telehealth Digital Health Financing

International Harmonization: Not Just For Audits Anymore

The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.

International Regulation Compliance

Human Factors Experts Forge Ahead With ‘Tricky’ In-Person Studies In The Age Of Coronavirus

Sanofi usability expert Molly Story and other longtime human factors professionals detail some extraordinary measures they’re taking to keep study participants and moderators safe, from the simple (masking up) to the more extreme (using separated testing rooms). Also: the US FDA weighs in on remote testing.

Safety Clinical Trials Coronavirus COVID-19

Device Week, 18 September 2020 – Keeping The ‘Human’ In Human Factors Amidst COVID-19

In the age of coronavirus, human factors professionals are doing their best to find their way through the pandemic by putting unique twists on usability testing to see what works and what doesn’t in the new reality. That’s the topic of this week’s podcast.

Device Week Safety Coronavirus COVID-19

CMS Final Kidney Disease Treatment Model To Encourage More Home Dialysis

The US Medicare agency introduced a new end-stage renal disease treatment model on Friday to incentivize use of home dialysis.

Policy Reimbursement Government Payers

Infographic: Glucose Monitor and Insulin Pump Markets To Reach A Combined $17.9Bn By 2023

The markets for glucose monitors and insulin pumps together have a four-year growth rate of over 12%, with the...

Device Week Podcast





Discussed in this episode:


Start-Up Spotlight: Nuvo Group’s Remote Monitoring Platform Could Make Prenatal Checks More Accessible

Israel-based Nuvo Group offers pregnant women prenatal checkups via its FDA-cleared remote monitoring platform.

Start-up Spotlight StartUps and SMEs


Recent Tweets from Medtech Insight


Latest from PR Newswire


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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Refined FDA Analysis Report Finds 2 Fewer Deaths Linked To Essure

In a 15 September update of adverse events from Bayer’s now-defunct Essure birth control device, the US agency tallies patients’ unwanted pregnancies and describes serious injuries.

Policy FDA Post Market Regulation & Studies

EU Designates 17th Notified Body Under MDR

Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.

EU Europe Slovakia

Latest From Policy & Regulation

Taskforce On Telehealth Policy Releases Final Recommendations On Safeguarding Virtual Care Beyond Pandemic

The recommendations include lifting geographic restrictions on originating sites, reinstating HIPAA provisions and eliminating restrictions on telehealth across state lines.

Telehealth Coronavirus COVID-19

FDA Gives Insight On Changing Approval Landscape

Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.

Regulation Approvals

Warning Letter Roundup & Recap – 16 September 2020

Two companies were sent FDA warning letters for selling adulterated COVID-19 tests, while a third was dinged for selling its transilluminator device for breast evaluation without agency approval or clearance.

Device Warning Letters FDA

EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

Europe EU

Sen. Schumer Calls On HHS Head Azar To Resign

Chuck Schumer, the top Democratic senator, is calling on HHS secretary Alex Azar to resign, accusing him of putting politics over public health.

Leadership Policy

Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’

Jeff Shuren, director of the US FDA’s device center, signaled on 15 September that the agency might not have the hotly anticipated draft of its retooled Quality System Regulation ready for release by next month.

Quality Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Warning Letter Roundup & Recap – 16 September 2020

Two companies were sent FDA warning letters for selling adulterated COVID-19 tests, while a third was dinged for selling its transilluminator device for breast evaluation without agency approval or clearance.

Device Warning Letters FDA

EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

Europe EU

Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus

William Maisel says FDA investigators are putting their best foot forward when conducting facility inspections amidst the coronavirus pandemic.

FDA Enforcement

Commercial Explore this Topic

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Start-Up Spotlight: OrthoSon Targets Back Pain With Ultrasound, Injectable Hydrogel Combo

The Oxford University spin-off has raised over £3m so far to develop its minimally invasive disc nucleus replacement technology and plans a £10m series A.

Research & Development Start-up Spotlight StartUps and SMEs

Latest From Commercial

Execs On The Move: Shuffling At Pacific Biosciences Of California; Curis CEO Goes To Metabomed

Pacific Biosciences of California’s former CEO steps down to be director and senior fellow for technology development, while its former chairman takes his old job; Metabomed hires a new CEO from Curis; Asterias CFO makes a lateral move to Rockwell Medical; and more.

Appointments Commercial

Taskforce On Telehealth Policy Releases Final Recommendations On Safeguarding Virtual Care Beyond Pandemic

The recommendations include lifting geographic restrictions on originating sites, reinstating HIPAA provisions and eliminating restrictions on telehealth across state lines.

Telehealth Coronavirus COVID-19

Interview: Data And Connected Insight In Arthroplasty Will Take Corin Beyond COVID

Corin has transformed from a niche UK hip resurfacing company into an innovative global player in orthopedics with a portfolio that includes robotics. UK managing director Paul Gibbons explained the group’s approach to business during COVID-19, and its culture of innovation.

Commercial Orthopedics

Takeda Offloads Surgical Patch To Corza Health For €350M

Johnson & Johnson previously agreed to acquire TachoSil but terminated the transaction due to regulatory hurdles.

M & A Deals

Medica Germany Joins The ‘Virtual Club’ For 2020

Medica, the world’s largest medtech, IVDs, rehab and health care systems exhibition, will be held in virtual form in 2020.

International Commercial

Apple Adds Blood Oxygen Sensor To Apple Watch

The company is sponsoring research on how the blood oxygen sensor feature on its Apple Watch 6 could be applied to specific health problems.

Digital Health Clinical Trials

Clinical R&D Explore this Topic

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Beyond Diabetes: Abbott Launches Glucose Sport Biosensor For Athletes To Track Blood Sugar

Analyst Larry Biegelsen expects Abbott’s CGM move into the consumer market could open a large new marketing opportunity.

Launches Diabetic Care Diagnostics

Latest From Research & Development

Polyganics Initiates Clinical Trial For Actiseal Surgical Patch

The Dutch company received the US FDA's breakthrough device designation in 2018 for the surgical patch.

Liver & Hepatic Surgery

Apple Adds Blood Oxygen Sensor To Apple Watch

The company is sponsoring research on how the blood oxygen sensor feature on its Apple Watch 6 could be applied to specific health problems.

Digital Health Clinical Trials

FDA Approves Two New Indications For Edwards’ Sapien 3 TAVR System

Sapien 3 is now indicated to treat failed right ventricular outflow tract conduits, surgical bioprosthetic pulmonary valves and transcatheter aortic valves.

Approvals Clinical Trials

Azalea Vision Formed To Develop Artificial Iris

Researchers have created the "smart contact lens" to dynamically improve the vision of people with various optical defects.

Clinical Trials Ophthalmology

Alydia Health Prepares US Launch For Maternal Care Device

The Jada system has received 510(k) clearance from the US FDA to treat postpartum hemorrhage and abnormal postpartum uterine bleeding.

Approvals Gynecology & Urology

Grail Files For $100M IPO, Plans To Launch Multi-Cancer Early Detection Test In 2021

Grail hopes to launch its Galleri test in 2021 as a laboratory developed test and submit a PMA to the US FDA in 2023.

Financing In Vitro Diagnostics
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