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Medtech Connect 16: AI For Cross Border Regulation

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

Digital Health Manufacturing

China Market For Medtech: Opportunity Or Headache?

Medtech companies have typically seen a “mixed picture of growth” in China in the past year or two, but it is a market that requires ongoing commitment, a panel of experts argued at the MedTech Forum 2024.

China Market Access

Fatty Liver Disease Drug Approval Opens New Patient Population In Imaging Market

The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

Regulation Liver & Hepatic

WHO Launches 'One-Stop Shop' For Global Information On Medical Devices

The Medical Devices Information System (MeDevIS) platform, launched by the WHO this week, consolidates information on 2,301 device types and streamlines device nomenclature to support informed decision-making by governments, regulators, payers, and healthcare providers.

International Supply Chain

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

FDA Patents

FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

Regulation FDA

Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee

The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.

Policy Advisory Committees

Floreo CEO Champions FDA Path For Autism VR Therapy

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

Digital Health Reimbursement

UK NHS, Industry Agreement On Artificial Pancreas Pricing Clears Way For Takeoff

The UK’s national rollout of hybrid closed loop (HCL) technologies marks NHS England as the global leader in providing equitable and fair access to next-generation diabetes management, Partha Kar, type 1 diabetes and technology lead, told Medtech Insight. Market leader Medtronic offers perspective.

United Kingdom Reimbursement

News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

Regulation Commercial

Implantica CEO On Potential New Standard Of Care For Treating GERD: RefluxStop

Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.

Europe United Kingdom

Radiologists Ask For AI-Focused Reimbursement Pathway

The pathway, which would be separate from breakthrough device reimbursement, would allow new AI technology to be reimbursed based on “clinical value and public stakeholder engagement.”

Medicare Artificial Intelligence

Industry Finds Innovative Revenue Streams For Digital Therapeutics

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

DTA Digital Health

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

What’s New In Digital Therapeutics? Investment Strategies, Reimbursement And More From DTA Annual Summit Day 1

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

DTA Digital Health

European IVD Industry On Rocky Road; Veer Toward 'Pockets of Growth'

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

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