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How The MDR Is Making The EU Competitively Backward

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.

Europe EU Regulation

More Robots In The Operating Room Could Mean More Lawsuits In The Courtroom

With the era of medical automation upon us, surgeons are increasingly turning to robots and artificial intelligence for better results in the OR. But when things go wrong, who’s to blame?

Legal Issues Artificial Intelligence Robotic Surgery

Digital Platform Caresyntax Extends Series C To Total $130M Raised

Caresyntax raised $130m in total funding to expand commercialization of its software that seeks to reduce variability and improve outcomes in the operating room.

Financing Artificial Intelligence Digital Health

Time To Comment On ‘Bold New Regulatory Regime’ For UK

Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.

Ireland United Kingdom Medical Device

Execs On The Move: Zimmer Biomet Announces ZimVie Spin-Off Roles

Zimmer Biomet has announced who will help newly named ZimVie spine and dental spin-off business.

Executive Changes Companies Commercial

Overflow Issue With Abbott COVID Tests Could Result In False Positives

The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.

Regulation Commercial Companies

QUOTED. Scott Whitaker.

Industry representatives like AdvaMed president Scott Whitaker have criticized the US Medicare agency’s decision to withdraw a rule that would give temporary automatic coverage to breakthrough devices.

Quoted Medicare Innovation

Device Week Podcast


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AAOS 2021: Digital Tools In Surgical Ecosystem, Software-Enabled Tech, Robots, Wearables, Sensors

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

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Policy & Regulation Explore this Topic

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Device Manufacturing Firm Settles Discrimination Charges

The US Department of Justice says that the company violated federal law by demanding specific documents from new employees, rather than allowing employment eligibility to be demonstrated in a range of ways.

Regulation Legal Issues United States

Final Guidance From FDA Maintains Relaxed Restrictions On Face Coverings

The US Food and Drug Administration continues to ease up on rules around various types of face protectors and respirators throughout the duration of the COVID-19 pandemic, so long as they do not pose an undue risk to the public health and provide proper labeling.

FDA Coronavirus COVID-19 Durable Medical Equipment

Latest From Policy & Regulation

New FDA Office Aims To Improve IT Interactions With Sponsors

The US agency’s new Office of Digital Transformation will aggregate a number of IT operations under one office to streamline the agency’s work, including its interactions with device sponsors.

FDA Policy

CMS Dashes Industry Hopes For MCIT Rule Any Time Soon

The US Medicare agency has proposed to withdraw a rule that would give temporary automatic coverage to breakthrough devices, stating the rule doesn’t meet its evidence threshold and could put patients at risk.­­­­­­­

Regulation Medicare

Industry Needs Direction And Support As Notified Body Powers Strengthen

Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶  and the EU regulatory outlook is becoming worrisome.

EU Europe

FDA Greenlights First-Of-Its-Kind Heart Software

The authorization means that similar technology, known as interventional cardiovascular implant simulation software, can be cleared for market via the 510(k) pathway in the future. 

Approvals Cardiology

EN ISO 13485 Linked To MDR and IVDR At Last

Nearly four months after the full application date of the EU’s Medical Device Regulation, the EU standards bodies have updated the most critical medtech standard to align it with the new EU medtech regulations.

Europe EU

US Regulation Of Fat Transfer Devices Shifts To FDA Biologics Center

The move is consistent with a 2007 guidance document, which said that devices that use human cells or tissue to create a therapeutic agent at the point of care should be regulated as biologics.

Regulation Review Pathway

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

FDA Sounds Alarm: Cluster Of Class I Recalls Prompts Aluminum Toxicity Warning From Agency

The US agency has warned health care providers that certain devices used to warm fluids for bodily circulation could leach dangerous levels of aluminum.

Recalls Safety

FDA Slaps Class I Label On Recall Of Eco-Med Ultrasound Gels, Lotions

Now-defunct Canadian manufacturer Eco-Med Pharmaceutical Inc. initiated the recall of its gels and lotions – sold under an array of product names – because there’s a chance they could be contaminated with harmful bacteria.

Recalls Safety

Industry Needs Direction And Support As Notified Body Powers Strengthen

Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶  and the EU regulatory outlook is becoming worrisome.

EU Europe

OUTLOOK 2021

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

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Procept BioRobotics Seeks $164M To Go Public

The company is selling 6,556,000 shares at $25 a share to support the commercialization of its AquaBeam robotic system for minimally invasive treatment of benign prostatic hyperplasia.

Financing Gynecology & Urology Robotic Surgery

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Device Week, 16 September 2021 – AAOS Conference Wrap-up; Exciting New Diagnostic Method

In this week's podcast Medtech Insight’s Marion Webb gives a summary of this year’s American Academy Of Orthopedic Surgeons annual meeting, where she discusses new products from a range of companies, and interesting meetings with executives. UK-based reporter Barnaby Pickering sheds light on Owlstone Medical’s new diagnostic method, and managing editor Reed Miller highlights a story about the troubled Stereotaxis.

Device Week Diagnostics

Zimmer Biomet’s Dental And Spine Spin-Off Will Be Called ZimVie

The company also named ZimVie’s management team, led by CEO Vafa Jamali.

M & A Dental Oral

Illumina Accelerator Invests In Seven Genomics Start-Ups

Illumina selected seven start-ups to join the third funding cycle of its Accelerator in the US and UK.

Commercial Companies

Flywheel.io Raises $22M And Buys Out Competition

A series C funding round will enable Flywheel.io to buy out Radiologics and continue development of its clinical trial data management products.

M & A Financing

Dexcom COO Quentin Blackford Takes CEO Job At iRhythm

The move is supported by iRhythm investors and disappointed Dexcom’s shareholders.

Executive Changes Patient Monitoring

Judge OKs Class-Action Suit From Allergan Investors

The lawsuit says that Allergan repeatedly downplayed the cancer risk its textured breast implants posed as compared to those from other manufacturers.

Legal Issues Commercial

Clinical R&D Explore this Topic

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Stereotaxis Continues Its Turnaround, Bringing Robots To Endovascular Intervention

In an interview with Medtech Insight, Stereotaxis CEO David Fischel explained how the company intends to continue its recovery after a troubled near decade of decline.

Robotic Surgery Innovation Financing

Latest From Research & Development

Illumina Accelerator Invests In Seven Genomics Start-Ups

Illumina selected seven start-ups to join the third funding cycle of its Accelerator in the US and UK.

Commercial Companies

Zoll Medical Signs Definite Agreement To Buy Itamar Medical For $538M

The combination of Zoll Medical and Itamar Medical would help strengthen the collaboration between the worlds of cardiology and sleep medicine, Jon Rennert, Zoll’s CEO said.

Digital Health Financing

European Study Is Good News For Sleep Apnea Devices

Patients with obstructive sleep apnea treated with positive airway therapy experienced significantly better outcomes than those not receiving the treatment, according to a new European study. After a series of setbacks, the study is positive news for sleep apnea device makers.

Research & Development Europe

AAOS 2021: Digital Tools In Surgical Ecosystem, Software-Enabled Tech, Robots, Wearables, Sensors

At the live AAOS conference, exhibitors, including major orthopedics players, demoed digital innovations, software-enabled technologies, robotics and smart implants that are expected to create efficiencies in the surgical continuum and provide data to improve outcomes.

Orthopedics Robotic Surgery

Cardiovascular Catch-Up: Abbott, Medtronic, Boston Scientific Stay Hot During Summer

June, July and August brought a number of important new approvals and trial announcements from the major cardiac device companies. Here are some of the highlights you might have missed during the summer.

Clinical Trials Research & Development

Device Week, 1 September 2021: Future Of Surgery Part 3; Fracture Fixation Overview

In this week’s podcast, Marion Webb discusses the future of robotic surgery and Barnaby Pickering breaks down the trauma fixation device market.

Device Week Clinical Trials
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