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Featured Stories

The EU’s New Batteries Regulation: When And How Its Requirements Will Impact Medtech

The EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.

EU Europe Medical Device

Federal Government Takes Action To Protect American Data

The Biden administration issued an executive order to protect American data privacy. On the same day, the Senate HELP committee released its report on health data privacy with suggestions to update HIPAA for a modern healthcare world. 

Policy Digital Health Safety

The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

‘We’re coming back,’ Oncology Center of Excellence Director Richard Pazdur says. Office of New Drugs Director Peter Stein says transition from virtual to in person will be gradual because FDA is trying to be sensitive to adcomm members' need to schedule travel and demands on their time.

Advisory Committees FDA Regulation

Global Medtech Guidance Tracker: February 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

Guidance Documents Regulation International

Spotlight On AI Regulation

Experts Press For New Artificial Intelligence Regulatory Approaches

Rigid regulations are delaying patient access to life-saving technology and preventing AI innovation in the EU, researchers say. A new paper from the publishers of Nature gives concrete proposals for how to adapt EU regulatory approaches to support innovative health tech.

EU Europe

Medtech Insight Podcasts


This Episode:

Medtech Connect Episode 12: Apple’s Patent Infringement Cases
 

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

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Global Device Regulation

DOJ: False Claims Settlements Neared $2.7Bn In 2023

The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.

Enforcement Regulation

UnitedHealth Group Cyber Attack Disrupts Major Pharmacies For A Week With No End In Sight

Systems from Change Healthcare are experiencing disruptions for the seventh day in a row after a ransomware attack on parent company UnitedHealth Group.

Cybersecurity Regulation

‘Deep Concerns’ Raised Over EHDS Regulation By Medtech Industry

Health stakeholder organizations including COCIR and MedTech Europe have issued a press statement outlining 10 fundamental issues with the European Health Data Space Regulation. The groups’ areas of focus include: legal clarity and member state harmonization; coordination and cooperation with existing infrastructures and stakeholders; and training.

EU Europe

UK MHRA Seeks New Leader As Dame June Says She Is Stepping Down

The medicines and medical devices regulator hopes to appoint a new CEO by the autumn to take over from Dame June Raine, under whose leadership the MHRA became the first agency in the world to authorize a COVID-19 vaccine.

United Kingdom Regulation
Digital Health

News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance

This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.

Regulation Digital Health

AdvaMed Principles For Artificial Intelligence Focus On Patient, Physician Needs

AdvaMed’s principles for artificial intelligence deb focus on using the technology to meet patient needs.

Digital Health Regulation

Down To Earth: NASA Discoveries Advance Human Health

While the latest missions from NASA may seem like the stuff of science fiction, discoveries from outer space are not only unlocking the mysteries of the cosmos, but improving technologies used every day on Earth, including those in the medtech industry.

Research & Development Robotics

SVB’s Milo Bissin Predicts ‘Reckoning In 2024’ For Health Care Companies With Sky-High Valuations

VC funding will remain challenging for many in the health care industry, Silicon Valley Bank’s market manager Milo Bissin told attendees at the recent DHIS West conference. Companies focusing on promising areas such as AI-powered technologies, women’s health and value-based care likely have the best chances to draw investors’ attention.

Artificial Intelligence Business Strategies
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Interviews

Experts Press For New Artificial Intelligence Regulatory Approaches

Rigid regulations are delaying patient access to life-saving technology and preventing AI innovation in the EU, researchers say. A new paper from the publishers of Nature gives concrete proposals for how to adapt EU regulatory approaches to support innovative health tech.

EU Europe

Abbott Moves Forward With TriClip G4 TTVR After Successful Advisory Panel

After an FDA advisory panel voted in support of Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device, Medtech Insight discussed the panel’s review with Barathi Sethuraman, DVP for clinical affairs for Abbott’s structural heart business.

Advisory Committees Companies

Freenome Bags Another $254m As Study Results Draw Closer

Freenome, the Roche-backed early cancer detection liquid biopsy developer has raised yet more money, making it one of the best-funded companies in its sub-sector. With trial results due relatively soon, investors are likely hoping this will be the last funding round required before full commercialization.

Diagnostics Cancer

Prostate Screening: UK Industry Body Explores Role In Study, Points To Growing Diagnostics Remit

Early diagnosis information is central to disease detection and will reduce treatment costs overall, says Nishan Sunthares, who heads the Association of British HealthTech Industries’ work on diagnostic technologies including IVDs.

United Kingdom Policy
Podcasts

Diagnostics CEOs In Triplicate Weigh In On Upcoming Hurdles

Tune in to this one-off podcast feature discussing the state-of-play in the diagnostics sector, with guests from ImmunExpress, Lucid Diagnostics and ChromaCode. 

Blood & Coagulation Disorders Diagnostics

Medtech Connect Episode 12: Apple’s Patent Infringement Cases

Medtech Insight regulatory reporter Hannah Daniel speaks to Sanjay Voleti, AliveCor’s chief business officer, about his company’s patent infringement case against Apple and what it’s like to take on a tech giant over intellectual property.

Intellectual Property Legal Issues

5-Minute Podcast: An SME's Environmental Sustainability Challenge − Pennine Healthcare

Medtech SME Pennine Healthcare has a range of business challenges to navigate, but compliance with heightened environmental sustainability standards has rapidly risen up its list of priorities.

Sustainability Policy

Cardio Conversations: AVS' Talks About Starting A Company In A Pandemic, Cracking Peripheral Plaques And More

In this edition of Cardio Conversations, Medtech Insight editor Reed Miller talked to Robert Chisena, the co-founder and CTO of AVS (Amplitude Vascular Systems) where leads research and product development. He talked about his company's novel interventional technology for calcified peripheral arterial disease and how the company came together despite the pandemic.

Cardio Conversations Cardiovascular
See All
Recent Stories

DOJ: False Claims Settlements Neared $2.7Bn In 2023

The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.

UnitedHealth Group Cyber Attack Disrupts Major Pharmacies For A Week With No End In Sight

Systems from Change Healthcare are experiencing disruptions for the seventh day in a row after a ransomware attack on parent company UnitedHealth Group.

‘Deep Concerns’ Raised Over EHDS Regulation By Medtech Industry

Health stakeholder organizations including COCIR and MedTech Europe have issued a press statement outlining 10 fundamental issues with the European Health Data Space Regulation. The groups’ areas of focus include: legal clarity and member state harmonization; coordination and cooperation with existing infrastructures and stakeholders; and training.

Execs On The Move: January 2024

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

News We're Watching: Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More

Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.

UK MHRA Seeks New Leader As Dame June Says She Is Stepping Down

The medicines and medical devices regulator hopes to appoint a new CEO by the autumn to take over from Dame June Raine, under whose leadership the MHRA became the first agency in the world to authorize a COVID-19 vaccine.

News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance

This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.

FDA Guidance Doc Would Waive Registration Fees For Bankrupt Small Businesses

The document waives the annual registration fee for companies with gross sales below $1m that are currently going through bankruptcy.

Canary Speech’s Voice AI Can Help Detect Alzheimer’s With 40-Second Conversation

AI voice tech start-up Canary Speech is developing algorithmic models for detecting behavioral health, progressive neurological and cognitive diseases based on a 40-second recording of speech. Medtech Insight caught up with Canary CEO Henry O’Connell at DHIS West to learn more about the company and its plans.

NICE Recommends Endoscopic Sleeve Gastroplasty To Treat Obesity

NICE has recommended endoscopic sleeve gastroplasty for the treatment of obesity in adults.

New EU Regulation Extending IVD Deadlines Expected In April

IVD manufacturers look set to be granted up to 18 more months to comply with the EU IVD Regulation very soon.

AdvaMed Principles For Artificial Intelligence Focus On Patient, Physician Needs

AdvaMed’s principles for artificial intelligence deb focus on using the technology to meet patient needs.

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