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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.
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 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.
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.
Spotlight On COVID-19
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.
FDA’s ‘Clearly Very Concerned’ About Delta COVID-19 Variant, CDRH’s Shuren Says
First Test That Predicts Severe Outcomes In COVID-19 Patients Receives CE Mark
‘Never Again’: Shuren Talks COVID-19 Lessons At FDA Small Business Event
FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
OUTLOOK 2021
Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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