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QUOTED. April 13, 2018. Ora Dar.

Check out what Ora Dar, from the Israel Innovation Authority, had to say about the country's plans to branch out globally in digital health.

Israel Digital Health

Insights From the Wells Fargo Health Care Conference

Medtech executives at the the Wells Fargo Healthcare Conference talked about the challenges facing them now, including hospital staffing shortages, supply chain constraints, and inflation. Here are some of the highlights from their comments

Business Strategies Commercial

Inflation, Supply Chain Headaches And Staffing Shortages: CEOs Talk About 'Big Picture' Challenges

Although procedure volumes have mostly recovered from the shock of COVID-19 two years ago, the effects of the pandemic on the medtech sector and the economy overall will be felt for years to come. In recent analyst and sales and earnings presentations, CEOs of major medtech companies faced questions about how their company is handling these major "macro" issues.

Leadership Sales & Earnings

QUOTED. Toon Overbeeke.

Dutch-based Vitestro will soon enter pivotal trials with its autonomous blood-sampling device, which it hopes to market in 2024, pending regulatory approval. See what Vitestro’s CEO, Toon Overbeeke, said about one of the challenges in the ongoing development of the phlebotomist robot here.

Quoted Launches

QUOTED. Dennis Gucciardo.

The FDA’s proposed Quality Management System Regulation (QMSR) does not say if a regulation limiting the types of reports FDA investigators can review will be kept in place, which concerns some observers – including Morgan Lewis partner Dennis Gucciardo.

Quoted Quality

QUOTED. Oliver Bisazza.

In the EU, lack of regulatory predictability is creating frustration and sending innovators across the Atlantic. MedTech Europe director Oliver Bisazza considered the issue in a conversation with Medtech Insight.

Quoted Europe

QUOTED. Harel Gadot.

Medtech Insight talked with XACT Robotics’ executive chairman Harel Gadot about plans for the FDA-cleared ACE robotic system and market opportunities. See what Gadot said about the market opportunity here. 

Quoted Cancer

QUOTED. Moshe Shoham.

Medtech Insight talked with Moshe Shoham about the innovative technologies and successful medical robotics companies, like Mazor Robotics, that were spun out of his lab at the Technion Institute. See what Shoham said about the future of robotic-assisted surgeries.

Quoted Digital Health

QUOTED. Cathy McMorris-Rodgers.

US House of Representatives Energy and Commerce committee ranking member Rep. Cathy McMorris-Rodgers, R-WA, raised questions about the $3bn earmarked for new health research agency ARPA-H during user fee hearings on 11 May.

Quoted Legislation

QUOTED. John Milad.

Since closing its $245m funding raise, Quanta Dialysis Technologies has been scaling up its commercial infrastructure and bolstering its US presence. CEO John Milad told Medtech Insight what that means for the company.

Quoted Innovation

QUOTED. Jeff Shuren.

Jeff Shuren, the director of the US FDA Center for Devices and Radiological Health, is urging lawmakers to come up with modern digital health regulatory frameworks and more strongly tackle cybersecurity issues. See what Shuren said about it here.

Quoted Digital Health

QUOTED. Daniele Bollati.

With demand for EU notified body medtech services fast outstripping capacity, Daniele Bollati, an auditor at Italy’s IMQ, explained how the shortage is affecting his organization's customer relationships.  

Quoted EU

QUOTED. Monika Paule.

Caszyme CEO and 2022 In Vivo Rising Leader Monika Paule is on a mission to expand the CRISPR toolbox of available proteins to enhance diagnostic tools, therapeutics and even agricultural practices.

Quoted Leadership

QUOTED. Suzanne Schwartz.

The US FDA issued a new guidance on 8 April that outlines a comprehensive approach device manufacturers can take to address cybersecurity concerns throughout the total product life cycle of their products. See what Suzanne Schwartz, director of the agency’s Office of Strategic Partnerships and Technology Innovation, said about it here.

Quoted Cybersecurity

QUOTED. Martha Shadan.

Medtech Insight spoke what Martha Shadan, CEO of Miach Orthopaedics, about the company’s marketing efforts for its FDA-cleared BEAR implant for treating anterior cruciate ligament (ACL) tears. See what Shadan said about it here.

Quoted Clinical Trials

QUOTED. Brian Savoie.

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) will put on the Medcon conference this year. RAPS exec Brian Savoie spoke to us about what each of the groups brings to the table.

Quoted FDA
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