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23andMe Acquires Telehealth Company Lemonaid Health For $400M
With the acquisition of Lemonaid Health, at-home genome testing company 23andMe hopes to transform the primary care business with genetics insights.
FDA Guidance Priorities For FY 2022 Include Transitioning EUAs; List Includes CDS Software Again
The US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.
Compliance Corner: Here’s How Stryker Decides Whether To Launch A Device Recall
Stryker Corp. regulatory expert Ommeed Shahrokh explains the device giant’s decision-making process around product recalls and describes what’s included in recall letters to customers.
AliveCor Partners With SolveCare To Integrate ECGs Into Telehealth
AliveCor’s KardiaMobile EKG devices will be connected to SolveCare’s global telehealth exchange to allow users to share EKG data with their doctors through SolveCare’s blockchain platform.
Spotlight On Recalls & Safety
Rust Cause: Cook Medical Recalls Medical Needles Because They Might Be Rusty
The company recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.
MRA Or Not, Swiss Medtech Industry Urges Maximum Convergence With EU MDR
Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the Swiss industry is anxious that new national regulations do not impose higher hurdles than the EU MDR. At present, there is a risk of that happening.
Certus Gets Funding From Pentagon To Develop Devices That Could Save Lives On The Battlefield
The US Department of Defense is helping Salt Lake City-based medical device company Certus Critical Care develop AI-enabled technology to treat catastrophic wounds on the battlefield and beyond.
COVID-19: FDA To Hold 3 More Virtual Town Halls In November, December
The US agency has announced three additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.
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Medtronic ‘Refreshes Brand,’ Announces New Environmental, Social, and Governance Targets
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Notified Bodies Group: New Euro AI Regs Could Cause Undue Burdens
The European medical devices notified bodies association says a proposed rule published earlier in the year risks forcing manufacturers, regulators and notified bodies to duplicate their work.
CMS Should Create New Roadmap For Breakthrough Technologies, Trade Group Urges
The Medical Device Manufacturers Association wants the US Medicare agency to come up with a new rule for implementing a coverage pathway for breakthrough devices by June 2022.
Latest From Policy & Regulation
December FDA Panel Meeting Set For Stroke Patient Implant
Brainsgate’s ISS500 can reportedly lessen stroke symptoms if put into use within 24 hours of the onset of symptoms.
FDA Targets Makers Of OTC COVID-19 Tests With Tweaks To 2 EUA Templates
The US agency made changes to two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for over-the-counter use and to offer “flexible study recommendations.”
Settlements Announced In Three ‘Electro-Acupuncture’ False-Claims Cases; Charges Filed Against Billing Consultant
Fraudsters have reportedly billed the government for the treatment, which uses electric impulses to replace the traditional needles of acupuncture.
Hear! Hear! Industry Responds To FDA Proposal On OTC Hearing Aids
The FDA’s recent proposal to allow hearing aids to be sold over the counter without a prescription has mostly been met with approval. Many Americans, however, are unaware of the plan.
Importer And Distributor Repackaging And Relabeling In The EU: New Guidance Published
It is vital that importers and distributors in the EU who are repackaging and relabeling medical devices know their responsibilities under the new MDR and are aware that they could be moving into manufacturer territory. New guidance spells out the new rules.
EMA Consults On Proposed Framework For Patient Preference Studies
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.
Quality Control & Compliance Explore this Topic
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Latest From Quality Control
UK To Up Transparency By ‘Auto Registering’ Trials
The UK Health Research Authority (HRA) has partnered with an international clinical trials registry to make it easier for sponsors and researchers to comply with the mandatory requirement of registering their studies in an established public database within a specific time frame.
Rust Cause: Cook Medical Recalls Medical Needles Because They Might Be Rusty
The company recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.
EU Has Now Designated 30 Notified Bodies For Medtech Products
Latest EU MDR notified body designation brings total in Italy to six, the same as Germany.
OUTLOOK 2021
Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings
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Market Intel: Lessons Learned From COVID-19: A Global Perspective On Digital Health Transformation
Health leaders in Sweden, Norway, Australia, Canada and Taiwan predicted the universal impact of digital solutions during the pandemic and lessons learned that will impact future care.
Latest From Commercial
CTA’s Standards For Digital Therapeutics Clears Up ‘Industry Confusion’
The Consumer Technology Association hopes its newly developed standard for digital therapeutics will clear up industry confusion and encourage the adoption of these treatments.
Device Week, 21 October 2021 – Post-Pandemic Perspectives; Good And Bad News For Medtronic
In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.
Execs On The Move: Promotions At Intuitive
Intuitive has appointed new chief financial, commercial and strategy and growth officers.
J&J Pushes Back Launch Of Ottava Robotic Platform By Two Years
The company originally expected the first-in-human trial of the soft-tissue robotic surgery system to begin in late 2022 and reach the market by 2023, but the company now expects those trials to begin in 2024.
Inivata Continues Trials Of Its Liquid Biopsy Platform
The partnership with the Princess Margaret Cancer Center will support two studies of liquid biopsy testing for lung cancer.
Exec Chat: Abionic Is Accelerating Diagnostics To Save Lives
Abionic CEO Nicolas Durand explains how Abionic is filling unmet needs in diagnostics and the Swiss company’s plans for expansion.
Clinical R&D Explore this Topic
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Cardiovascular Catch-Up: TAVR Withstands Delta Virus So Far; Stereotaxis Robot Succeeds In Trial
The impact of the Delta variant of COVID-19 on procedure volumes remains a major concern for transcatheter valve makers, Abbott launches a new PFO closure device, and more highlights from the cardiovascular technology market in early October.
Latest From Research & Development
CTA’s Standards For Digital Therapeutics Clears Up ‘Industry Confusion’
The Consumer Technology Association hopes its newly developed standard for digital therapeutics will clear up industry confusion and encourage the adoption of these treatments.
J&J Pushes Back Launch Of Ottava Robotic Platform By Two Years
The company originally expected the first-in-human trial of the soft-tissue robotic surgery system to begin in late 2022 and reach the market by 2023, but the company now expects those trials to begin in 2024.
Exec Chat: Abionic Is Accelerating Diagnostics To Save Lives
Abionic CEO Nicolas Durand explains how Abionic is filling unmet needs in diagnostics and the Swiss company’s plans for expansion.
FDA Reminds Diagnostics Makers Of Rules On Research Using Human Specimens
Even research using leftover, deidentified specimens must be reviewed by an IRB, the US agency said in a letter to industry.
Medtronic Pushes Completion Of Pivotal Renal Denervation Trial To Late 2022
The company announced that results from the pivotal SPYRAL HTN-ON MED trial of its Symplicity renal denervation system will not be available until the trial completes enrollment next year. The company previously expected to be able to present favorable interim results from the trial in November.
Dexcom Announces CGM Real-Time Data Now Available On Garmin Wearables, Bike Computers
Dexcom is making CGM data available through consumer devices starting with Garmin’s smartwatches and bicycle computers.
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