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FEATURED STORIES

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CAPITAINER POSITIONS ITS QDBS TECHNOLOGY AS CATCH-ALL BLOOD TESTING SOLUTION
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The Swedish company has tweaked its dried blood spot sampling technology so that
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 * 20 Feb 2023

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MEDTECH SMES SET OUT REGULATORY NEEDS AS UK ADVANCES POST-EU SYSTEM

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 * 22 Feb 2023

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WHY NICE IS BUILDING THE MEDTECH INNOVATION PLANE AS IT FLIES

By Eliza Slawther

England’s NICE is ditching the rulebook in favor of “failing forward faster”
when it comes to tackling medtech innovations. The organization’s interim
director of medical technology says this approach mirrors the entrepreneurial
nature of the medtech, diagnostics and digital sectors.

Europe United Kingdom Health Technology Assessment
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 * 20 Feb 2023

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ANOTHER NOTIFIED BODY DESIGNATION COMING DOWN THE LINE UNDER THE EU MDR

By Amanda Maxwell

With two IVD Regulation notified body designations in the last week, there
should be one more notified body listed under the Medical Device Regulation
designation shortly. But then there is likely to be a gap.

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 * 17 Feb 2023

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EXEC CHAT: BUTTERFLY NETWORK BRINGS MATERNAL ULTRASOUND TO UNDERSERVED REGIONS

By Reed Miller

Medtech Insight talked to Sachita Shah, Butterfly Network's director of global
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POLICY & REGULATION EXPLORE THIS TOPIC

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 * 09 Feb 2023

 * NEWS


INNOVATIVE DIAGNOSTIC FOR BABIES WINS NICE EARLY VALUE ASSESSMENT PILOT BACKING

By Eliza Slawther

An innovative genetic test that can detect which babies are likely to develop
deafness if treated with a common antibiotic is set to receive conditional
funding in the UK under NICE’s rapid evaluation pilot scheme.

EU United Kingdom Diagnostics
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 * 10 Feb 2023

 * NEWS

 * 


REPORT FINDS MOST FDA-APPROVED AI DEVICES ARE USED FOR IMAGING

By Hannah Daniel

The pace of artificial intelligence development has accelerated in recent years
and now most of the artificial intelligence devices approved by the FDA are
imaging devices.

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LATEST FROM POLICY & REGULATION


GERMAN REFORM: ‘SENSE OF PROPORTION’ URGED BY HOSPITALS

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 * 23 Feb 2023

 * ANALYSIS

By Ashley Yeo

Germany’s hospital reform continues apace, most recently with changes to
emergency care. The hospitals themselves have now submitted an impact analysis
of the government’s structural and reimbursement proposals.

Policy Germany


FDA UPDATES SLEW OF RADIOLOGY GUIDANCE DOCUMENTS

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 * 22 Feb 2023

 * NEWS

By Elizabeth Orr

The US Food and Drug Administration has released revised versions of six
guidance documents to reflect new x-ray reporting requirements, among other
changes.

Regulation FDA


IMPLEMENTING THE EU MDR AMENDMENT: “MESSY” AND “A LOT TO FIGURE OUT ON THE HOOF”

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 * 21 Feb 2023

 * INTERVIEWS

By Amanda Maxwell

The EU Medical Device Regulation amending regulation is not some kind of
“bail-out or blanket extension” for manufacturers, medtech expert lawyer Erik
Vollebregt warns. But it offers valuable opportunities to already-prepared
manufacturers.

Europe EU


TOTAL NUMBER OF IVD REGULATION DESIGNATIONS REACHES 10

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 * 20 Feb 2023

 * NEWS

By Amanda Maxwell

Two EU IVDR notified bodies have now been designated this week. NSAI of Ireland
has been designated as a notified body under the IVD Regulation, the tenth under
the EU’s IVDR, and is specializing in self-testing.

Europe EU


NEWS WE’RE WATCHING – MEDICARE COVERS DEXCOM CGM; NEW MPOX EUA; $106M PATENT
VERDICT AGAINST MEDTRONIC

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 * 17 Feb 2023

 * NEWS

By Brian Bossetta, Hannah Daniel and Elizabeth Orr

Medicare announced coverage for the Dexcom G7 continuous glucose monitor, as
well as a breast cancer indication for Natera Inc.’s Signatera; the FDA
authorized a new monkeypox test; the FDA issued a warning letter to a Texas
masks firm; and a new report says NIST labs are failing behind. 

Regulation Policy


HOW CAN THE EU GET CLINICAL EVALUATIONS FOR HIGH-RISK DEVICES RIGHT?

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 * 17 Feb 2023

 * INTERVIEWS

By Eliza Slawther

The new EU medtech regulations were developed as a reaction to unsafe products
reaching patients; yet implementing new rules on clinical evidence has been
anything but smooth. An expert from the BioMed Alliance tells Medtech Insight
how this challenge can be addressed.

Europe EU


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FDA UPDATES SLEW OF RADIOLOGY GUIDANCE DOCUMENTS

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 * 22 Feb 2023

 * NEWS

By Elizabeth Orr

The US Food and Drug Administration has released revised versions of six
guidance documents to reflect new x-ray reporting requirements, among other
changes.

Regulation FDA


GREATER TRANSPARENCY FOR MEDICARE ADVANTAGE PROGRAM NEEDED, MDMA SAYS

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 * 16 Feb 2023

 * NEWS

By Hannah Daniel

Medtech industry groups call for greater transparency and oversight for Medicare
Advantage plans.

Medicare Policy


EU GIVES FINAL THUMBS UP TO ALTERING TRANSITION DEADLINES FOR MDR LEGACY
PRODUCTS

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 * 16 Feb 2023

 * NEWS

By Amanda Maxwell

EU institutions have unanimously agreed to amendments to support the
implementation of the Medical Device Regulation. The speed at which this has
been done reflects the urgency of new measures to address the EU’s crisis.

Europe EU


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 * 21 Feb 2023

 * NEWS


MINUTE INSIGHT: MEDTRONIC’S EXTRAVASCULAR ICD EARNS EUROPEAN APPROVAL

By Jane Reed

The Aurora extravascular implantable cardioverter defibrillator and the Epsila
extravascular lead earned a CE mark supported by results from a global pivotal
study.

Minute Insights Clinical Trials Commercial

LATEST FROM COMMERCIAL


DEALS SHAPING THE MEDTECH AND DIAGNOSTICS INDUSTRY, JANUARY 2023

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 * 23 Feb 2023

 * DATA

By Barnaby Pickering

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 January 2023. Data
provided by Citeline's Biomedtracker.

Medical Device Commercial


MINUTE INSIGHT: METHINKS SECURES CE MARK FOR AI-BASED STROKE DETECTION PRODUCT.

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 * 23 Feb 2023

 * NEWS

By Barnaby Pickering

MeThinks Stroke Suite uses convolutional neural networks to identify hemorrhage
and occlusions within the brain.

Digital Health Innovation


INVESTOR EYE: CHARITIES COULD BE THE BEST OPTION FOR START-UPS

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 * 16 Feb 2023

 * INTERVIEWS

By Barnaby Pickering

One of the UK’s largest charities, Macmillan, has launched a fund to invest in
start-ups that aim to benefit the lives of cancer patients.

Platform Technologies Financing


EXEC CHAT: ABBOTT WANTS TO IDENTIFY HEART FAILURE PATIENTS EARLIER

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 * 16 Feb 2023

 * INTERVIEWS

By Reed Miller

Abbott executives Philip B. Adamson and Robert Kormos talked to Medtech Insight
about how the company is trying to slow the progression of heart failure and
reduce heart failure hospitalizations.

Exec Chats Patient Monitoring


NEXTMED HEALTH OR ‘WHEN BURNING MAN MEETS HEALTH CARE AT THE BEACH,’ JUST WEEKS
AWAY

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 * 15 Feb 2023

 * INTERVIEWS

By Marion Webb

The XMed conference, now NextMed Health, returns to the Hotel del Coronado with
packed programming. Health care innovators will join leaders from industry,
governments, organizations and academia to discuss the future of health care.

Innovation Artificial Intelligence


MINUTE INSIGHT: INSULET ACQUIRES INSULIN PUMP PATENTS FROM BIGFOOT, AGC

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 * 14 Feb 2023

 * NEWS

By Reed Miller

Insulet will acquire insulin pump patents from Bigfoot Biomedical for $25m,
which Bigfoot will use to expand its Unity diabetes management system. Insulet
also announced the acquisition of automated insulin delivery assets held by
Automated Glucose Control.

Minute Insights Intellectual Property


CLINICAL R&D EXPLORE THIS TOPIC

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 * 10 Feb 2023

 * NEWS


GE HEALTHCARE TO BUY AI IMAGING FIRM CAPTION HEALTH TO BOLSTER ULTRASOUND
BUSINESS

By Marion Webb

GE HealthCare’s acquisition of Caption Health is part of the company’s wider
investment strategy to bring innovative technologies in-house.

Artificial Intelligence Digital Health Innovation

LATEST FROM RESEARCH & DEVELOPMENT


EXEC CHAT: ABBOTT WANTS TO IDENTIFY HEART FAILURE PATIENTS EARLIER

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 * 16 Feb 2023

 * INTERVIEWS

By Reed Miller

Abbott executives Philip B. Adamson and Robert Kormos talked to Medtech Insight
about how the company is trying to slow the progression of heart failure and
reduce heart failure hospitalizations.

Exec Chats Patient Monitoring


LUX CAPITAL’S DEENA SHAKIR BULLISH ON WOMEN’S HEALTH: ‘FUNDAMENTALLY A MASSIVE
MARKET OPPORTUNITY’

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 * 07 Feb 2023

 * INTERVIEWS

By Marion Webb

Medtech Insight talked with Lux Capital’s general partner Deena Shakir about her
investments in women’s health, untapped opportunities and barriers, gender
equality in investment, and her outlook for investment in women’s health.

Exec Chats Women's Health


MINUTE INSIGHT: J&J MONARCH ROBOT REMOVES KIDNEY STONE WITH MINI-PCNL PROCEDURE

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 * 07 Feb 2023

 * NEWS

By Reed Miller

The company is sponsoring the first clinical study of robotically assisted
electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy
– kidney stone removal – with the Monarch robotic-assisted platform for urology.

Minute Insights Clinical Trials


WOMEN’S HEALTH EXPERT PANEL ADDRESSES CHALLENGES, OPPORTUNITIES IN POST-ROE ERA

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 * 30 Jan 2023

 * ANALYSIS

By Marion Webb

After years of underfunding, stigmatization and lack of research, companies
working on products and services that address women’s health care are gaining
traction. But the sector also faces unique challenges, such as gaining approval
for ads on major social media platforms.

Women's Health Digital Health


MINUTE INSIGHT: ABBOTT WINS EXPANDED FDA APPROVAL FOR PROCLAIM XR SPINAL CORD
STIMULATOR FOR DIABETIC PERIPHERAL NEUROPATHY

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 * 26 Jan 2023

 * NEWS

By Marion Webb

Abbott said a major competitive benefit of the Proclaim XR SCS system is the
battery life of up to 10 years at low settings.

Minute Insights Approvals


DIGITAL HEALTH ROUNDUP: CES 2023 HIGHLIGHTS; US FDA VR, AR WEBSITE; BAYER’S
POWERS UP ON RADIOLOGY

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 * 24 Jan 2023

 * ANALYSIS

By Marion Webb, Reed Miller and Barnaby Pickering

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides
highlights from the recent CES 2023 conference in Las Vegas. Reed Miller
discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby
Pickering highlights Bayer’s jump into medtech with its buyout of Blackford
Analysis.

Digital Health Artificial Intelligence


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