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Executive Exclusives

Set Alert for Executive Exclusives and Hindsight 20/20

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

Diversity & Inclusion Business Strategies

VERIGRAFT Is Taking A Fresh Approach To Personalized Tissue Grafting

The Swedish company has developed a proprietary method of personalizing venous grafts, and plans to bring it – alongside some other products – to the market.

Medical Device Diabetic Care

Spinning Around – One Company's Bid To Diagnostic-ify The Metabolism

Lifespin is working on tools to characterize a patient’s metabolism and provide more detailed information about a disease.

In Vitro Diagnostics Metabolic

Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

FDA Regulation

Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

Digital Health Diagnostics

Q&A: Jeffrey Shapiro Talks Device Approval Strategy And More

The seasoned regulatory attorney, who recently moved to law firm King & Spalding, spoke to Medtech Insight about his priorities, what keeps him interested in device law, and the three things manufacturers should consider when seeking a device approval.

FTC Health Breach Proposal Could Create Confusion For HIPAA Entities

Medtech Insight followed up with Invitae’s Deven McGraw about further possible confusion that could be caused by the Federal Trade Commission’s proposed amendments to the Health Breach Notification Requirements (HBNR).

Policy Safety

GaitBetter On Mission To Bring VR, AI-Based Solution To Gait Training; Will Physical Therapists Pay For It?

Israeli-based medtech company GaitBetter is hoping to make bigger strides in bringing its VR- and AI-based gait training and rehabilitation solution to more physical therapy clinics in the US.

Neurology Innovation

Should Pharma Firms Cover CDx Costs For Precision Cancer Drugs?

Significant financial reward awaits drugmakers that invest more in companion diagnostics during the development and marketing of precision cancer drugs, says Peter Keeling, CEO of Diaceutics – but Novartis warns that relying on pharma firms to fund these tests is unsustainable.

In Vitro Diagnostics Personalized Medicine

The Book Of GLP-1s: For Medtech They Giveth, As Well As Taketh Away

GLP-1 inhibitors for weight loss are rapidly threatening several medtech segments; however, in ensuring their long-term efficacy, digital health companies could benefit.

Digital Health Platform Technologies

Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel

The European medical device database, Eudamed, is arguably the missing lynchpin in the implementation of the EU’s Medical Device and IVD Regulations. Medtech Insight spoke with Lionel Tussau of atrify to discover what companies need to know now and how actors should be preparing.

EU Europe

New Public Citizen Health Lead To Keep Banging Drum On Stronger Benefit-Risk Ratios

Robet Steinbrook, the third director of the 50-year-old health group, plans to stay true to the organization’s long-held mission of holding FDA approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.

Drug Safety Drug Approval Standards

Medtech Connect Episode 8: Exploring Regulatory Differences Between The EU And US

In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations. If you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.

Medtech Connect Digital Health

Orthopedics Corner: Catalyst Looks To Clinical Data To Distinguish Its Shoulder Arthroplasty Technology

Orthopedics Corner is a new series highlighting new developments in spine and orthopedics technology you may have missed. Catalyst OrthoScience CEO Carl O’Connell, along with surgeon and researcher Matthew Budge, talked to Medtech Insight about Catalyst’s innovation in shoulder arthroplasty.

Clinical Trials Orthopedics

MDR Amending Regulation Improves Communication and Workflow But Thorny Issues Remain

In the EU, the amending regulation to the MDR is not creating as many waves as the amending regulation to the IVDR did. The reasons are many.  But this is good news for the medtech industry, as is a general uptick in purposeful communication.

Europe EU

Old Tech, New Tricks: The ‘Game-Changing’ Potential In Thermal Imaging For Diabetes

Thermal imaging technology has existed for almost 100 years, but still has plenty of untapped power in medical diagnostics. Finnish healthtech Thermidas explains why its AI-assisted thermal imaging software is a potential game-changer for people with diabetes.

Europe EU
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