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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.
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.
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.
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.
Spotlight On US FDA
FDA Gives Insight On Changing Approval Landscape
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’
Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus
Consensus Standards: FDA Guidance Describes Recognition Process
FDA: Two-Step Test Can Find Reg Status Of Non-Device Functions
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.
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.
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.
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...
Latest News
Device Week Podcast
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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.
Data Trackers
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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.
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.
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.
FDA Gives Insight On Changing Approval Landscape
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
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.
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.
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.
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 Control & Compliance Explore this Topic
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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.
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.
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.
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.
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.
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.
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.
Takeda Offloads Surgical Patch To Corza Health For €350M
Johnson & Johnson previously agreed to acquire TachoSil but terminated the transaction due to regulatory hurdles.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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