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MedTech Forum 2023: Why The Commission Must Not ‘Shoot For The Moon’ With EHDS Plans
EU policymakers have ambitious goals to enable greater sharing of electronic health data through the creation of a European Health Data Space, but experts at the MedTech Forum conference urged the commission to ensure its regulation is implementable.

DTA Standardizes Definition Of Digital Therapeutics
The Digital Therapeutics Alliance (DTA) released a standardized definition and guidance for digital therapeutics during its annual meeting in Washington, DC. The move comes as part of a push toward standardization for the fast-changing field.

Cardio Catch-Up: Boston Scientific Moves Forward With Cryoablation In Parallel With PFA
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition focuses on FROZEN AF, the pivotal trial of Boston Scientific's POLARx cryoablation system. New results from the trial were presented at the Heart Rhythm 2023 meeting in New Orleans in May.

Cardio Catch-Up: Boston Scientific's Next-Gen Watchman FLX Pro Reduces Thrombi Risk In Trials
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. Boston Scientific is promoting pre-clinical research of the next generation version of its Watchman left-atrial appendage closure device
Spotlight On AI Diagnostics
TytoCare Plans To Integrate More AI Into Diagnostics To Drive Longitudinal ‘Family’ Care At Home
Medtech Insight recently sat down with TytoCare’s chief commercial officer Tamir Gotfried to discuss plans for driving virtual care in the home, and engage physicians and consumers, at a time when pandemic-era state-level telehealth flexibilities continue to evolve.

News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.

Abbott Invests Millions In Clinical Trial Diversification Efforts
Abbott is investing millions of dollars in its Diversity in Research Office to diversify clinical trials in the industry.

Cardio Catch-Up: Boston Scientific's Next-Gen Watchman FLX Pro Reduces Thrombi Risk In Trials
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. Boston Scientific is promoting pre-clinical research of the next generation version of its Watchman left-atrial appendage closure device
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Canada Proposes List Of ‘Critical Products’ & More Agile Regulation To Address Shortages
The Canadian government says stakeholders are “poised for action” to improve the collective response to medical product shortages and has come up with some questions and possible answers as to how best to go about it.

FTC Health Breach Notification Amendments Underscore Need For Federal Legislation, Expert Says
Former deputy privacy director of HHS Deven McGraw spoke to Medtech Insight about the shortfalls of the FTC’s proposed health breach notification amendments.
Latest From Policy & Regulation
FDA Seeks Feedback On Attempt To Modernize Clinical Trials
The US FDA has released a draft guidance from the International Council for Harmonisation that aims to modernize clinical trials. The agency is requesting feedback on the draft, which includes updates on good clinical practices.
Is The Implementation Of The EU Medtech Regulatory Structure Entering A New Phase?
Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?
Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials, and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations, and Kaminski shares a personal story about why the safety of medical devices matters so much to him.
EU AI Act Legal Deep-Dive Part 1: What Can Medtech Expect, And When?
The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.
FDA Tweaks Q-Sub Meeting Guidance
The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.
Quality Control & Compliance Explore this Topic
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Latest From Quality Control
Is The Implementation Of The EU Medtech Regulatory Structure Entering A New Phase?
Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?
Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
FDA Adds More MDRs, Deaths, To Philips Ventilator Tally
Less than a month after Philips released test results that it said showed the company’s much scrutinized sleep therapy devices were safe, the FDA has reported more complaints, including deaths, associated with the machines.
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Medtronic Creates Chief Technology And Innovation Officer Role
Ken Washington, the former general manager of consumer robotics, will help the company “accelerate innovation-driven growth.”
Latest From Commercial
Cardio Catch-Up: Two Studies Support Boston Scientific’s Subcutaneous ICD
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition covers the two clinical studies of Boston Scientific's Emblem MRI subcutaneous implantable cardioverter defibrillator.
Cardio Catch-Up: Boston Scientific's Farapulse PFA Shows Short Learning Curve In European Registry
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition recaps the presentation of results from EU PORIA, a European registry atrial fibrillation patients treated with Boston Scientific's Farapulse pulsed field ablation system.
Execs On The Move: New Leaders for Vyaire, Nevro, And More In May 2023
An interactive summary of recent executive-level company changes and promotions in the medical device and diagnostics sectors.
Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
Akili Introduces Adult Version Of Video Game Therapy To Lessen ADHD Symptoms
Video game therapy developer Akili Interactive launched a mobile video game therapy to reduce ADHD symptoms in adults. The company plans to seek FDA clearance.
Minute Insight: Owlstone Medical’s 'Breath Biopsy' Tech Adopted By US Military
The company will create a handheld version of its FAIMS technology, to be used in rapid testing for transmissible illnesses in combat scenarios.
Clinical R&D Explore this Topic
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Exec Chat: PacBio Addresses Latest Results, New Tech And Long-Read Sequencing’s Future
PacBio has been burning through investors’ cash as it works to make long-read sequencing more accessible. Neil Ward, the company’s general manager, laid out his thoughts on the technology, its place in the market and how genomics data can be both effectively and fairly utilized.
Latest From Research & Development
Cardio Catch-Up: Two Studies Support Boston Scientific’s Subcutaneous ICD
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition covers the two clinical studies of Boston Scientific's Emblem MRI subcutaneous implantable cardioverter defibrillator.
Cardio Catch-Up: Boston Scientific's Farapulse PFA Shows Short Learning Curve In European Registry
Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations that you may have missed. This edition recaps the presentation of results from EU PORIA, a European registry atrial fibrillation patients treated with Boston Scientific's Farapulse pulsed field ablation system.
Novo Nordisk In Negotiations To Acquire Medical Device Maker Biocorp For About $165M (€154M)
After a nearly two-year collaboration, Novo Nordisk said it has begun talks to buy a controlling stake in French medical device company Biocorp.
Minute Insight: Inbound Health Now Offers Post-Surgical Hospital Care At Patients’ Homes
The hospital-to-home care movement is rising, and Inbound Health wants to be at the forefront of enabling health systems and health plans nationwide to bring hospital-level care into the home, now adding general surgery to its offerings.
Exec Chat: Abbott’s Burton Talks About Abbott’s Plans To Address Chronic Pain With SCS
Allen Burton, the medical director of Abbott’s neuromodulation business and a leader in pain medicine, talked to Medtech Insight about the FDA’s new labeling for Abbott’s spinal cord stimulation devices that includes non-surgical back pain.
White House Takes Steps To Advance ‘Responsible’ AI That ‘Upholds Democratic Values’
The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.
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