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FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall

The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.

Coronavirus COVID-19 Recalls Regulation

Hologic Adds Vessel Sealing Tech By Acquiring Bolder Surgical For $160M

Colorado-based Bolder recently announced the global launch of the CoolSeal vessel sealing platform, which will complement Hologic’s obstetrical/gynecological surgery product line.

M & A Gynecology & Urology Surgery

Democratic Lawmakers Want ACA Contraceptive Coverage Enforced

The Affordable Care Act requires health insurers to cover contraceptives; some lawmakers in the US House want to make sure those requirements are upheld.

Legislation Policy FDA

Why The Commission Had No Choice But To Propose New Transition Periods For The EU IVDR

While it was obvious to those in the sector that the implementation of the EU IVD Regulation was heading for a disaster, this article looks at the facts and figures that helped sway the European Commission to propose new transition periods to better manage its implementation.

EU Medical Device In Vitro Diagnostics

Spotlight On Recalls & Safety

FDA Warns Of Overdose Risk For ENFit Syringes

The US FDA issued a safety communication to patients and health care providers about the potential for overdose when using ENFit low dose tip syringes, and also told manufacturers to update labeling to account for the risk.

FDA Safety

Abbott COVID-19 Lab Test Recall Deemed High-Risk Class I

The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.

Regulation Recalls Safety

Execs On The Move: A Relatively Quiet Week For Executive Appointments

Invent Medic Sweden has appointed a new chief executive officer and OncoCyte appointed a new chief operating officer.

Executive Changes Commercial Companies

Deals Shaping Medtech And Diagnostics, September 2021

Medtech Insight's Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – in vitro diagnostics and medical devices – and then categorized by type – acquisition, alliance, or financing. This month’s column covers deals announced in September 2021. Data provided by Biomedtracker.

Deals Financing M & A

Device Week Podcast


In This Episode:

Boston Scientific Acquisition, And Poor SPAC Float

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

More Podcasts

Recent Tweets from Medtech Insight

Latest from PR Newswire

Click here to access further medical device and diagnostics news.

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

TEAM-NB Training Sessions Aim To Harmonize Best Practice At Time Of Rapid Change

With new EU medtech regulation in place, demand for qualified and well-trained staff at notified bodies is at an all-time high. As an abundance of new auditors are faced with a steep learning curve ahead, moves are afoot to harmonize practices.

Europe EU Medical Device

COVID-19: Report Finds Staffing, IT Issues Posed Challenges To EUA Process

The agency asked consultants Booz Allen Hamilton to evaluate its handling of diagnostic EUAs as a way to prepare for potential future pandemics.

Policy FDA Diagnostics

Latest From Policy & Regulation

European Commission Gives In On IVDR Delays: Proposal For New Transition Periods

The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.

EU Europe

Alcohol, Repeat Attendees Could Raise Red Flags On Speaker Programs, OIG Attorney Says

Benjamin Wallfisch, a senior attorney at the Office of the Inspector General in the US Department of Health and Human Services, recently discussed how companies can avoid apparent violations of anti-kickback law while hosting educational programs.

Compliance Regulation

Device Week, 13 October 2021 – Spotlight On The Latest Medtech Industry News From The EU

In this week’s podcast,  EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.

Regulation EU

FDA Updates Guidance On Unique Device Identification Labeling For Class I Devices

The US FDA’s most recent guidance revises UDI requirements for class I and unclassified medical devices the agency issued in July. Class I devices categorized as consumer health products will be exempt from some submission requirements.

FDA Regulation

EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.

EU Europe

Chinese Volume-Based Procurement Pilot Hits Medtech Stock Prices

The consequences of China’s volume-based, centralized procurement of medical supplies, initiated in 2018, are starting to become clear, according to reports from Omdia.

China Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

European Commission Gives In On IVDR Delays: Proposal For New Transition Periods

The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.

EU Europe

Alcohol, Repeat Attendees Could Raise Red Flags On Speaker Programs, OIG Attorney Says

Benjamin Wallfisch, a senior attorney at the Office of the Inspector General in the US Department of Health and Human Services, recently discussed how companies can avoid apparent violations of anti-kickback law while hosting educational programs.

Compliance Regulation

EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.

EU Europe

OUTLOOK 2021

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

VIEW NOW

Commercial Explore this Topic

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Medtronic ‘Refreshes Brand,’ Announces New Environmental, Social, and Governance Targets

The company reported its progress in key environmental, social, and governance areas over the past year along with some new performance targets related to sustainability and inclusion. Medtronic also added a new “tagline” to its brand.

Sustainability Diversity & Inclusion Commercial

Latest From Commercial

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.

Diabetic Care Digital Health

Point Of Care Diagnostics Market Projected To Continue Rapid Growth

A new report from Informa's Meddevicetracker highlights strong projected growth in the market, explaining the underlying reasons why.

Market Intelligence In Vitro Diagnostics

PDT Company Better Therapeutics Ready To Go Public With SPAC Deal

Better Therapeutics is developing prescription digital therapeutics for behavioral therapy to address the root causes of cardiometabolic disease.

Digital Health M & A

Pear Therapeutics Obtains First Medicaid Coverage For PDTs

Massachusetts’ Medicaid program will cover reSET and reSET-O prescription digital therapeutics for the treatment of substance abuse disorder and opioid use disorder.

Reimbursement Telehealth

FDA Clears Withings' Smart Watch For Detecting AF and Measuring Blood Oxygen

The French company is promoting its ScanWatch as the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist.

Approvals Retail

Medtech Companies Face Challenges And Choices When Going Public

In a panel discussion at The Medtech Conference, hosted by AdvaMed, CEOs discussed the challenges, benefits and technicalities surrounding an IPO.

Diversity & Inclusion Financing

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates

In this roundup of developments in digital health, we highlight the key news and announcements from August and September.

Digital Health Artificial Intelligence Commercial

Latest From Research & Development

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.

Diabetic Care Digital Health

FDA Clears Withings' Smart Watch For Detecting AF and Measuring Blood Oxygen

The French company is promoting its ScanWatch as the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist.

Approvals Retail

Medtronic’s Hugo Surgery Robot Enters European Market

Medtronic’s robotic-assisted surgery system earned a CE mark approval for urologic and gynecologic procedures, which make up about half of all robotic procedures.

Robotic Surgery Approvals

Leonardo DiCaprio-Backed Digital Therapeutics Company Raises $125M

MindMaze, which designs VR-based games to help people retore motor function after stroke or brain injury, will use the proceeds to accelerate marketing of its platform and run clinical trials.

Financing Digital Health

Cardiovascular Catch-Up: J&J RF Balloon Ablation; Biotronik Home Monitor; And More

September has been full of cardiovascular technology news, including announcements from Biotronik and Biosense Webster. Here are a few of the highlights.

Cardiovascular Cardiology

AAOS 2021: A Closer Look At Think Surgical’s Active, Open-Implant Orthopedic Robot And What’s Ahead

Medtech Insight sat down with Think Surgical’s CFO Paul Weiner at the recent AAOS conference to discuss the roll-out of the next-generation TSolution One TKA robot and company plans.

Robotic Surgery Orthopedics
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