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French Notified Body Anticipates UK Designation By Summer 2022

After the shake-up of notified bodies based in the UK in the wake of Brexit, GMED is one EU notified body that is hoping for its UK subsidiary to be designated as a UK approved body within the next six to nine months.

EU Europe Medical Device

Q3 Recalls Snapshot: Cardinal Health’s Recall Of 267 Million Syringes Causes Recalled Units To Swell

The number of recalled device units ballooned to a whopping 372,215,986 in the third quarter of 2021, mostly driven by an August recall of Monoject Flush Prefilled Saline Syringes by Cardinal Health. Check out our Q3 recalls infographic.

Recalls FDA Safety

Exec Chat: Alcon Seeks Vision ‘Utopia’ For Cataract Surgery Patients

Jeannette Bankes, the general manager of Alcon’s global surgical business, talked to Medtech Insight about how the company is addressing the cataract surgery market with a range of intraocular lenses intended to return the patients vision to as close to its natural optimal function as possible.

Exec Chats Ophthalmic Surgery

FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments

The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.

Policy Enforcement FDA

Comments Invited on European Commission Vision For IVDR EU Reference Laboratories

Two long-awaited European Commission proposals have been published which shed light on how EU reference laboratories will operate under the IVD Regulation and likely timelines.

EU Europe Policy

Three OTC COVID-19 Tests Win FDA Clearance After Template Updates

Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes. All three hold emergency use authorizations.

Diagnostics Coronavirus COVID-19 Policy

US FDA Proposes Making It Easier To Get Certain HIV Tests To Market

Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.

Regulation Policy FDA

Device Week Podcast


In This Episode:

Congenica Tries To Bring Clarity To Personalized Medicine For Rare Diseases

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics. >More Podcasts


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Infusion Pump Testing Takes Center Stage In TIR Guidance From AAMI

The Association for the Advancement of Medical Instrumentation’s new technical information report guides pump makers as they test their devices for a variety of clinical scenarios and conditions. TIR101:2021 also tackles flow rates, metrics, labeling, and more.

Standards International Safety

Podcast: How Do You Protect Yourself When Your AI Makes Mistakes?

Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.

Policy Commercial Artificial Intelligence

Latest From Policy & Regulation

App Developers Turning To HIPAA Compliance In Face Of Growing State Data Privacy Constraints

Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.

Patient Monitoring Legal Issues

Minute Insight: HHS Gets $35M Shot In Arm To Expand Telehealth For Family Planning

The US Department of Health and Human Services said on 23 November that the money will be used “to enhance and expand the telehealth infrastructure and capacity of Title X family planning providers.”

Telehealth Policy

Power Morcellation Containment Devices Placed In FDA Class II

The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.

Regulation FDA

Digital Health Technologies: Where The Shift Is Needed In The EU To Increase Uptake

The market for the reimbursement of digital health technologies is being held back because of the current fragmentation in reimbursement and funding. MedTech Europe is calling for change.

EU Europe

EU’s First IVDR Expert Panel View Published

The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.

EU Europe

FDA To Impose Premarket Requirements On Blood Lancets

Single-patient lancets will face new special controls and 510(k) submission, while multiple-patient lancets would require a PMA.

Regulation FDA

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

App Developers Turning To HIPAA Compliance In Face Of Growing State Data Privacy Constraints

Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.

Patient Monitoring Legal Issues

FDA Posts Study Confirming OD Risk From ENFit LDT Syringes

The US FDA has posted a study affirming a safety communication the agency issued in October that warned of overdose risk from certain low dose tip syringes.

Safety FDA

FDA Warns Of Severe Risks Associated With Medtronic Leadless Pacemakers

The US Food and Drug Administration has issued a warning to clinicians of the heightened risk for adverse events, including death, from potential cardiac perforation during implantation of Medtronic’s Micra Transcatheter Pacing System (TPS).

Safety FDA

OUTLOOK 2021

Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings

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Exec Chat: Medtronic’s Linnea Burman Targets 'Consensus-Driven Care' Using AI, Robotics In Spine Care

Linnea Burman, the general manager of enabling technologies for cranial and spinal technologies at Medtronic, talked to Medtech Insight about plans for the Mazor spinal robotic system, the incoming new president of the division, and other new developments.

Exec Chats Business Strategies Commercial

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Execs On The Move: Endologix Gets New CEO, Medtronic Appoints New Head Of Global Strategy

Bob Hopkins, previously the managing director at Bank of America Merrill Lynch, is now Medtronic's head of global strategy.

Commercial Companies

Device Week, 19 November 2021 – J&J Break-Up, And Genomic Diagnostics

On this episode of Device Week, Medtech Insight’s Marion Webb explains the recent announcement that Johnson & Johnson will split into two separate businesses – one focusing on medical products, and the other focusing on consumer. Barnaby Pickering discusses recent results from the UK’s 100,000 Genome project, and how its analysis partner, Congenica, hopes to deliver personalized medicine through widescale genomic testing.

Device Week Diagnostics

Angle Outlines Strategy As It Nears Major Regulatory Announcements

With approvals looming over the next few months, Angle spoke to Medtech Insight to probe deeper about its presentation at the 2021 Jefferies Healthcare Conference.

In Vitro Diagnostics Personalized Medicine

Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation

Cala Health’s FDA-cleared Cala Trio wearable for treating essential tremor is currently being tested in Parkinson’s disease patients and is targeting a $20bn global market opportunity.

Start-Up Spotlight Digital Health

Minute Insight: Big Medtechs Usually Do Well During High Inflation, But Not in 2021

A new analysis from Wells Fargo found that the big medtech stocks typically perform at least as well as the overall market when inflationary expectations are high, but 2021 defied that trend.

Minute Insights Coronavirus COVID-19

Minute Insight: Siemens Healthineers Launches The World's First Photon-Counting CT Scanner

Naeotom Alpha will allow for faster, more precise, and safer computed tomography imaging for cardiac imaging, oncology, and pulmonology.

Minute Insights Launches

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AI Expert: Awareness Is Key To Managing Biases

A Walden University professor discussed various types of biases AI/ML developers need to take into consideration during the recent Xavier Health AI Summit. She noted a working group will produce a white paper laying out different types of biases to raise awareness.

Research & Development Artificial Intelligence Digital Health

Latest From Research & Development

Cala Health Hopes To Jolt Essential Tremor Market With Wrist-Worn Non-Invasive Stimulation

Cala Health’s FDA-cleared Cala Trio wearable for treating essential tremor is currently being tested in Parkinson’s disease patients and is targeting a $20bn global market opportunity.

Start-Up Spotlight Digital Health

Minute Insight: Siemens Healthineers Launches The World's First Photon-Counting CT Scanner

Naeotom Alpha will allow for faster, more precise, and safer computed tomography imaging for cardiac imaging, oncology, and pulmonology.

Minute Insights Launches

Virtual MRI Tool Added To FDA Developer Resources

The computer-based software helps predict how devices will react to increased temperature in MRI machines.

Regulation FDA

Cardiovascular Catch-Up: Medtronic And Edwards Make Headlines At TCT Conference

The first half of November was full of cardiovascular device news, led by clinical trial results from renal denervation and transcatheter aortic valve trials presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Clinical Trials Research & Development

J&J To Split Consumer From Medtech and Pharmaceutical Businesses – Creating Two Companies To Unlock More Value, Growth, Innovation

Johnson & Johnson expects that the new J&J unit will be better positioned to share expertise such as combing medical devices with drugs and continue to innovate.

Financing Business Strategies

Minute Insight: Kaia Health Stretches Access To Online Physical Therapy With Luna Deal

Kaia’s digital therapy system will be available to users through a Luna On-Demand Physical Therapy, a provider of at-home physical therapy services.

Minute Insights Digital Health
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