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COVID-19 Tests: How The EU Rules Are Changing And Where Questions Still Lie
There are very few regulatory hurdles to placing a COVID-19 test on the EU market under the IVD Directive. This situation, however, is changing under the IVD Regulation. The European Commission explains what manufacturers need to weigh up when deciding their regulatory pathway.
Singapore Prepares UDI System, Malaysia Seeks Regulatory Improvements And Indonesia Adjusts To Changing Environment
Medtech industry representatives from ASEANMed member economies, notably Singapore, Malaysia and Indonesia, provided regulatory updates at the February Asia Regulatory Roundtable. These roundtables are organized by the ARQon consultancy and the Asia Regulatory Professional Association (ARPA). They are sponsored by Medtech Insight.
Start-Up Spotlight: Elypta Targets World’s First Metabolism-Based Early Cancer Diagnosis
The Swedish liquid biopsy start-up expects to be the first company to secure US FDA approval for a metabolism-based urine test for the early detection of kidney cancer in post-surgery patients.
Start-Up Scanwell Adds Another Collaboration, Targets Home COVID-19 Testing With BD
Scanwell Health, a leader in smartphone-enabled home diagnostics tests, has announced a partnership with Beckton Dickson.
Spotlight On US FDA
FDA Commissioner Race: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options
The White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as US FDA commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.
COVID-19: FDA Schedules 5 More Virtual Town Halls Through March
Experts: COVID-19, Departure Of Key FDA Staff Likely Contributing Factors For Delayed AI/ML Action Plan
FDA Adds 7 New Tools To Its Regulatory Science Toolbox
Coronavirus Variants Spur FDA To Write New Guidance For COVID-19 Test Developers
White House To Deliver 25 Million Face Masks To Low-Income Americans
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.
US High Court Punts On ‘Objective Falsity’ FCA Standard
Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
Latest News
Device Week Podcast
Discussed in this episode:
Market Intel: Rivalry Among Insulin Pump Makers Heats Up With Expected Launches In 2021
The global insulin pump market is expected to see double-digit growth, reaching $5.1bn in 2024, with product launches expected by Medtronic, Insulet, ...
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Policy & Regulation Explore this Topic
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When Will A Notified Body Conduct An MDR/IVDR Virtual Audit And How? BSI Netherlands Gives Its Views
When it comes to notified bodies deciding whether to undertake virtual audits or not in the context of the new EU medtech regulations, there are many elements that need considering and many different potential responses and cost implications. In this interview, BSI Netherlands explains its approach.
HHS Secretary Nominee Becerra Commits To Telehealth Expansion, Procedure Price Transparency
At two recent confirmation hearings, HHS secretary nominee Xavier Becerra promised Senators he would help expand telehealth and procedure price transparency.
Latest From Policy & Regulation
COVID-19: FDA Schedules 5 More Virtual Town Halls Through March
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
FDA Commissioner Race: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options
The White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as US FDA commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.
New AdvaMed Board Chair To Make Military Veteran Recruitment A Priority
A former Army ranger, Michael Minogue wants to help military veterans transition into and gain employment opportunities in the medtech industry.
Update On EU Standardization: Will CEN/Cenelec Accept Commission’s Latest Request?
The European Commission is optimistic that work on standards for the new EU medtech regulations will begin as soon as May. After previous setbacks, the medtech sector is pinning it hopes on the EU standards bodies, CEN and Cenelec, accepting the Commission’s latest proposal
Experts: COVID-19, Departure Of Key FDA Staff Likely Contributing Factors For Delayed AI/ML Action Plan
The recent artificial intelligence/machine learning software action plan released by the US agency took nearly two years to develop.
US Medicare Agency Makes It Easier For Texas Suppliers To Replace DME Lost To Winter Storms
Durable medical equipment suppliers get temporary HHS and CMS waivers to help Texas Medicare and Medicaid beneficiaries due to the state’s winter storm.
Quality Control & Compliance Explore this Topic
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Recall Of Valiant Navion Could Cost Medtronic $40M
The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.
FDA Adds 7 New Tools To Its Regulatory Science Toolbox
The US agency has updated its Catalog of Regulatory Science Tools.
2 Deaths, 22 Injuries Lead To Class I Recall For Hillrom Overhead Lift
The US FDA has designated a recall of Hillrom’s Liko Multirall 200 Overhead Lift as high-risk class I. The recalled lifts have been manufactured since 2000.
OUTLOOK 2021 IS LIVE
Access In Vivo’s annual showcase of special features and industry league tables, including Scrip 100
VIEW 2021 RANKINGSCommercial Explore this Topic
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Execs On The Move: Slew Of Directorships At Zimmer And 908 Devices
908 Devices, Zimmer Biomet and Ortho Clinical Diagnostics have all appointed new directors, Biolase promotes executive vice president to chief executive officer role, and more.
Latest From Commercial
NuVasive Adds Artificial Cervical Disc By Acquiring Simplify For $150M
Simplify’s total disc replacement complements NuVasive’s C360 line of cervical repair surgery devices, addressing a market that could eventually be worth $2.6bn.
Office Supply Vendor Faces Proposed Class Action Over Counterfeit N95 Masks
The proposed class action suit alleges that W.B. Mason took advantage of the pandemic by overcharging for the phony respirators.
Medtronic Claims Share Gains In Cardiovascular And Neurostim
The company’s revenue was down just 1% year-over-year in the third quarter of fiscal 2021, despite the ongoing impact of the pandemic.
New AdvaMed Board Chair To Make Military Veteran Recruitment A Priority
A former Army ranger, Michael Minogue wants to help military veterans transition into and gain employment opportunities in the medtech industry.
Truvian Sciences Raises $105M Series C To Fund Development Of Point-Of-Care Testing Platform
Truvian Sciences will use the proceeds to fund regulatory submission for its POC testing system in Europe and the US with hopes to bring to retailers, pharmacies, health systems in 2022.
Recall Of Valiant Navion Could Cost Medtronic $40M
The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.
Clinical R&D Explore this Topic
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Trial Shows Lateral Flow Antibody Testing Could Be Used To Assess COVID-19 Vaccine Efficacy
Abingdon Health has announced that a study run in conjunction with the UK Rapid Test Consortium has demonstrated that its AbC-19 test could be an effective tool for testing vaccine efficacy.
Latest From Research & Development
NuVasive Adds Artificial Cervical Disc By Acquiring Simplify For $150M
Simplify’s total disc replacement complements NuVasive’s C360 line of cervical repair surgery devices, addressing a market that could eventually be worth $2.6bn.
Medtronic Claims Share Gains In Cardiovascular And Neurostim
The company’s revenue was down just 1% year-over-year in the third quarter of fiscal 2021, despite the ongoing impact of the pandemic.
Truvian Sciences Raises $105M Series C To Fund Development Of Point-Of-Care Testing Platform
Truvian Sciences will use the proceeds to fund regulatory submission for its POC testing system in Europe and the US with hopes to bring to retailers, pharmacies, health systems in 2022.
FDA Adds 7 New Tools To Its Regulatory Science Toolbox
The US agency has updated its Catalog of Regulatory Science Tools.
Exec Chat: Steven Mickelsen Helps Acutus Translate Science Into Improved Outcomes
Mickelsen, an electrophysiologist at the University of Iowa, recently joined the rapidly growing San Diego-area company as Chief Translational Science Officer and is helping to guide the company’s development of novel electrophysiology therapies to treat cardiac arrhythmias.
ReWalk Plans $40M Private Placement To Fund Marketing, R&D Of Exoskeletons
ReWalk plans to use the proceeds to fund sales, R&D and reimbursement expenses related to its ReStore and Personal 6.0 devices as it continues to face negative effects of pandemic.
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