FDA Releases New Cybersecurity Premarket Guidance and Study Shows 10 Year Delay Before a New CPT Code is ReimbursableMay 19, 2022Regulatory US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions [...]
FDA releases MDUFA V commitment letter and Transitional Coverage for Emerging Technologies is under review at CMSApril 5, 2022Regulatory MDUFA V: US FDA sets performance goals for De Novo medical device reviews MDUFA V will set [...]
FDA Publishes Proposed Rule To Align QSR With ISO 13485 And CMS Adds New HCPCs Code For Prescription Digital TherapeuticsMarch 9, 2022Regulatory US FDA formally proposes aligning Quality System Regulations with ISO 13485 The US Food and Drug [...]
FDA Misses MDUFA V Deadline After Months Of Contentious TalksFebruary 1, 2022Regulatory FDA misses MDUFA V deadline after months of contentious talks FDA has failed to send the final [...]
FDA Expands eSTAR Filing To De Novo Devices, IVDsJanuary 11, 2022Regulatory FDA expands eSTAR filing to de novo devices, IVDs US medical device and in vitro diagnostic [...]
FDA Issues Draft Guidance For Device Software In Premarket SubmissionsDecember 3, 2021Regulatory FDA issues draft guidance for device software in premarket submissions The US Food and Drug [...]
CDRH outlines guidance plans for FY2022November 1, 2021Regulatory FDA nixes GUDID submission requirements for class I consumer healthcare devices Manufacturers of [...]
FDA Issues Draft Guidance On Electronic 510(k) Submissions and CMS Proposes to Repeal MCITOctober 11, 2021Regulatory FDA issues draft guidance on electronic 510(k) submissions The US Food and Drug Administration [...]
Salona Global Medical Device Corp. Announces Acquisition of Simbex, a Multi-Product, IP-Driven Medical Device CompanyOctober 4, 2021
FDA Seeks Increased Oversight of Medical Device Cybersecurity and New HCPCS Codes Issued for Medical DevicesSeptember 13, 2021Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional [...]
FDA and MDCG Release UDI Implementation GuidancesAugust 3, 2021Regulatory US FDA rolls out final guidance on Unique Device Identifier (UDI) labeling requirements The FDA has [...]
Medical Device Recalls Up in First Half of 2021 and Draft Cures 2.0 Bill Seeks Breakthrough CoverageJuly 1, 2021
Simbex Designs Bioentrepreneurship Educational Series for Dartmouth Innovations Accelerator for CancerMay 21, 2021
FDA Deregulates Certain Device Software FunctionsMay 4, 2021Regulatory FDA issues final rule removing certain software from medical device regulations The US FDA has [...]
Device Firms Oppose Proposed 510(k) Exemptions and CMS Delays Coverage of Breakthrough DevicesApril 2, 2021Regulatory Device, digital health firms oppose HHS’ proposed 510(k) exemptions Medical device and digital [...]
Key Concepts for Medical Device EntrepreneursMarch 2, 2021At Simbex, our holistic approach to product design centers on identifying risk at every stage of the [...]
UK Passes Post-Brexit Medical Device Regulation and Four Healthcare Payment Trends Expected for 2021March 1, 2021Regulatory UK passes post-Brexit medical device regulatory bill into law The cornerstone of the UK’s [...]
FDA Makes COVID Exemptions For Low-Risk Devices PermanentFebruary 3, 2021Regulatory Safer technologies program finalized by FDA A newly finalized guidance from the FDA smooths the [...]
ISO 14971: Managing Risk in Medical Device DevelopmentJanuary 25, 2021With the growth of medical device usage, the challenge for medical device developers and manufacturers for [...]
CDRH Priorities for 2021 and Strategies for Digital Health CompaniesJanuary 11, 2021A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]
FDA releases new EMC draft guidance and CMS increases home health reimbursement for 2021November 30, 2020A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]
Innovation at Simbex Highlighted by New Hampshire Union LeaderOctober 30, 2020Researchers and engineers with great ideas sometimes need help getting their innovations from the concept [...]
FDA Releases New Biocompatibility Draft Guidance and CMS provides further comment on “reasonable and necessary”October 30, 2020A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]
New Digital Health Center of Excellence & Coverage for “Breakthrough” DevicesSeptember 30, 2020A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering [...]
FDA Issues Pandemic Inspections Guidance & CMS Announces New Payment RatesAugust 31, 2020FDA issued an immediately effective frequently asked questions guidance explaining its approach to inspections [...]
How to Conduct a Technology & Intellectual Property Review for Medical DevicesAugust 21, 2020A Technology Review often begins with early assessment of the technology solution, which entails confirming [...]
Rx Rehab Exercise Devices Now 510(k) Exempt & First CMS Code for ExoskeletonsJuly 31, 2020Read the latest regulatory and healthcare reimbursement news, including the FDA exempts additional Class II [...]
More Remote Monitoring Devices Added to FDA’s EUA and a Step Forward for Digital Therapeutics ReimbursementJune 30, 2020Read the June, 2020 regulatory and healthcare reimbursement recap from Simbex, including the FDA expands [...]
How to Define Product Requirements for Medical DevicesJune 12, 2020A product requirements document is a collection of the many requirements that will define the expected [...]
A Call for Innovation in HealthcareJune 5, 2020As innovators ourselves, we recognize the opportunity to draw on the lessons-learned from this crisis, which [...]
International Regulators Talk of Phased Implementation & Telehealth Coverage Extends, But Usage Still FaltersJune 1, 2020The implementation of the Eudamed has been delayed by two years and the implementation of the Medical Devices [...]
MDR Officially Delayed and Telehealth is Here to StayApril 30, 2020Regulatory News MDR delay official as industry calls to push back IVDR The European Council voted 27-0 to [...]
Global Medical Device Regulators and Payors Adapt in Response to PandemicMarch 31, 2020Regulatory News FDA allows expanded use of devices to monitor patients’ vital signs remotely FDA does not [...]
COVID-19 UpdateMarch 30, 2020On Thursday, March 26, a stay-at-home order was issued for New Hampshire residents, including the closure of [...]
Medical Device Industry Braces for Life After Brexit and Silicon Valley Conference Focuses on Future of DTx ReimbursementFebruary 28, 2020
New Cybersecurity Guidances Under MDR and IVDR and Health Systems Invest in Remote Health MonitoringJanuary 31, 2020Regulatory News New guidance published for Medical Device and IVD Cybersecurity under MDR and IVDR in Europe [...]
EU Postpones MDR Adoption Requirement for Some Self-Certified Devices and Bill to Repeal Medical Device Tax Goes to VoteDecember 27, 2019Regulatory News European Parliament Adopts Second Round of MDR, IVDR Corrigenda This change means that devices [...]
FDA Delays Modernization of QSR and CMS Assigns Reimbursement Code to Pain Management DeviceNovember 26, 2019Regulatory News Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings in April 2020, FDA [...]
What is Special About Simbex?November 8, 2019A client recently told me, “Your team approaches product development problems differently than others – and it [...]
FDA to discuss EtO Sterilization and Providers are Unprepared for Upcoming Interoperability RulesOctober 30, 2019Regulatory News Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting On 6 and 7 [...]
Simbex Commercialization Center Receives $50,000 SBA AwardOctober 9, 2019Simbex’s NIH-Funded Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) [...]
FDA Issues Over 12 Major Medical Device Guidances in a Month and AI gets its First Procedural Billing CodeSeptember 30, 2019Regulatory News De Novo Requests: FDA Finalizes Three Guidances FDA finalized three guidance documents related [...]
CEO Rick Greenwald Joins Tuck Professor Sydney Finkelstein on The SydcastSeptember 5, 2019Rick Greenwald has spent his life working towards making sports and medical devices safer. A couple weeks ago, [...]
Co-Op Spotlight: Ian WoodSeptember 3, 2019Ian Wood has been working with Simbex as a Summer 2019 Marketing Co-op.
Simbex Launches New ActiveStep WebsiteAugust 30, 2019This month, we launched our new website for ActiveStep®. ActiveStep® is an instrumented treadmill that uses [...]
Co-Op Spotlight: Josh PosenAugust 28, 2019Josh Posen has been working with Simbex as a Summer/Fall 2019 Product R&D Co-op.
FDA Increases User Fees for 2020 and CMS Increases Payments for FDA Breakthrough DevicesAugust 28, 2019Regulatory News US FDA medical device user fees increase six percent for 2020 FDA medical device user fees for [...]
FDA Outlines Priorities for Advancing Public Health and Wearable Technology Data are Impacting Health Insurance PoliciesJuly 29, 2019Regulatory News Sharpless Outlines FDA’s Key Priorities for Advancing Public Health Acting FDA Commissioner [...]
EC Cautions on MDR’s Impact on Device Availability and New Executive Order Requires Transparency for Out of Pocket Healthcare CostsJune 27, 2019Regulatory News EC Cautions on MDR/IVDR Impact on Device Availability The European Commission acknowledged [...]
Simbex Co-op Spotlight: Chen QiuJune 26, 2019Chen Qiu has been working with Simbex as a Spring 2019 Software/Web Developer Co-op.
CDRH Officially Launches OPEQ and ONC’s Proposed Information Blocking Rule Gets Push Back Regarding FeesMay 29, 2019Regulatory News CDRH Announces Implementation of Office of Product Evaluation and Quality OPEQ will integrate [...]
Simbex CEO Rick Greenwald on Head Impact Monitoring in SportsMay 21, 2019Last week, Simbex CEO Rick Greenwald presented at the ASTM Sixth International Symposium on Safety in Ice [...]
FDA proposes framework for AI devices and opportunity for CMS payment increase to breakthrough devicesApril 26, 2019Regulatory News FDA Drafts Guidance on Inspections of Medical Device Establishments The three-page draft [...]
Simbex featured in NHBR write up for tech in the Upper ValleyApril 1, 2019Click here to read more on NHBR.com.
Outgoing FDA head calls for better regulation of EHRs and CMS announces AI Health Outcomes ChallengeMarch 29, 2019Regulatory News CDRH Qualifies 3rd Medical Device Development Tool The OsiriX CDE aims to standardize how [...]
First national registry of people who have lost limbs promises to collect data to improve prevention, treatment, and rehabilitationMarch 6, 2019The Mayo Clinic is partnering with the American Joint Replacement Registry and the Thought Leadership & [...]
Standardized approach to assess cybersecurity and progress in exoskeleton reimbursementFebruary 26, 2019Regulatory News FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices A [...]
FDA Pre-Cert, reduction in HACs, and telehealth regulationsJanuary 30, 2019Regulatory News Impact of the USMCA on the Medical Device Industry In the US-Mexico-Canada Agreement (USMCA), [...]
Alexa – What was at CES 2019 for consumer health technology?January 17, 2019Simbex CTO, Jeff Chu, and I attended the Consumer Electronics Show in Las Vegas last week. This year, CES had [...]
2018 Trends in Medical Device ReimbursementDecember 20, 20182018 Trends in Medical Device Reimbursement Telehealth: improvements in coverage and access No one can ignore [...]
2018 Trends in Medical Device RegulationDecember 19, 20182018 Trends in Medical Device Regulation The continued trend of consumer tech disruptors entering MedTech via [...]
NH Business Review Names Simbex and Rick Greenwald as a 2018 Business Excellence Awards RecipientNovember 2, 2018Rick Greenwald among 16 recipients honored at 16th annual award reception on Nov. 1 Lebanon, N.H. – November [...]
October, 2108 Medical Regulatory & Reimbursement NewsOctober 29, 2018General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]
September Medical Device Regulatory & Payment NewsSeptember 27, 2018General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]
August Medical Device Regulatory and Reimbursement NewsAugust 24, 2018General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]
TREAT Recognized by RESNA with Leadership AwardAugust 1, 2018The Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) was presented with [...]
July Medical Device Regulatory & Payment NewsJuly 24, 2018General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]
June Medical Device Regulatory & Payment NewsJune 29, 2018General | Software | Rehab & AT | Injury Prevention | Pain Management | Real World Evidence [...]
New Technologies with the Same Old ChallengesMay 14, 2018When do you know that you have completed requirements gathering and that your documentation is sufficient to [...]
Simbex at BIOMEDevice in BostonApril 19, 2018Simbex Chief Business Development Officer, Greg Lange, reports on what he saw at this year’s BIOMEDevice [...]
Dr. Richard Greenwald Inducted into American Institute for Medical and Biological EngineeringApril 10, 2018Washington, DC – The American Institute for Medical and Biological Engineering (AIMBE) has announced the [...]
Simbex Co-op Spotlight: Kavita BaradurMarch 29, 2018Kavita Baradur has been working with Simbex as a Spring 2018 Engineering Co-op. Learn more about her in our [...]
What’s New in Medical Device Regulation and Reimbursement for 2018February 4, 2018With so much changing in healthcare, we keep our finger on the pulse of medical device regulation and [...]
Call for Abstracts from TREATJanuary 20, 2018The NIH-funded Center for Translation of Rehabilitation Engineering Advances and Technology (TREAT) is seeking [...]
Greg Lange elected as Chair for Alice Peck Day Memorial Hospital Board of TrusteesJanuary 5, 2018Greg Lange, Simbex Chief Business Development Officer, was elected as Chair of the Board of Trustees for the [...]
Simbex Co-op Spotlight: Jomkit JujaroenJanuary 4, 2018Simbex welcomes Jomkit Jujaroen from Rochester Institute of Technology as a Spring 2018 Engineering Co-op. [...]
Accelerating Recovery from Stroke and Spinal Cord Injuries – Research Yields New Rehab OptionNovember 22, 2017“Ground-breaking research could change the lives of millions.” You have read the headlines, but what happens [...]
NEPDC Funds Three Companies for Pediatric Healthcare InnovationSeptember 1, 2017For a fourth year, NEPDC has announced funding and in-kind service support for solutions targeting a specific [...]
Simbex Featured in Valley News Enterprise MagazineMay 30, 2017Changing the Game: Simbex evolves from measuring head impacts to developing a variety of medical devices. Read [...]
2017 USA Hockey Annual Award Winners AnnouncedMay 17, 2017USA Hockey hosted its 2017 Annual Congress in Colorado Springs, Colorado. The four-day event provided USA [...]
Greg Lange joins Simbex as Chief Business Development OfficerJanuary 9, 2017Greg Lange joins Simbex as Chief Business Development Officer. Greg brings to Simbex 25+ years of healthcare [...]
Jonathan Beckwith Promoted to VP of Research and DevelopmentJanuary 2, 2017Jonathan Beckwith is promoted to Vice President of Research and Development. Jonathan was previously Director [...]
Rick Greenwald Elected to the National Academy of InventorsDecember 10, 2016CEO/President Rick Greenwald is elected to the National Academy of Inventors as a Fellow, the highest [...]
NEPDC Featured In NH Business ReviewNovember 8, 2016An associate professor of engineering at Dartmouth College, Kofi Odame was looking for a problem he could [...]
NEPDC and TREAT Award $150K to Medical Device InnovatorsSeptember 13, 2016Four winners announced in 2016 Target Challenge grant competition held by New England Pediatric Device [...]
NEPDC Awarded $50K for Small Business StartupsSeptember 12, 2016The U.S. Small Business Administration (SBA), through its Office of Investment and Innovation (OII), Office of [...]
Riddell Releases an Updated Version of InSite Player ManagementJune 9, 2016Riddell releases an updated version of InSite Player Management (ISPM 3.0) that revolutionizes head impact [...]
Center Receives $6.2M for Rehabilitation and Assistive TechnologiesFebruary 4, 2016Say that you have an idea for a product that would not only help someone regain independence after an injury, [...]
Simbex Co-Founder Named National Academy of Inventors fellowDecember 15, 2015Retired Dartmouth engineering professor Robert Dean holds 28 U.S. patents, with five more pending. Dean is the [...]
InSite Impact Response SystemOctober 10, 2014InSite Impact Response System® is a 2014 NH High Tech Council Product of the Year Finalist.
InSite Impact Response System Edison Award Gold Medal WinnerApril 30, 2014InSite Impact Response System® is a 2014 Edison Award Gold Medal Winner
Riddell’s InSite System Uses Advanced Helmet InsertsNovember 20, 2013Riddell’s new InSite system uses technologically advanced helmet inserts to alert sideline staff when football [...]
NEPDC Receives FDA Innovation and Commercialization AwardNovember 8, 2013The New England Pediatric Device Consortium (NEPDC), a non-profit research and education foundation aimed at [...]
Football Concussions Could Be Reduced By Riddell’s InSite SystemOctober 24, 2013“This is not a diagnostic tool.” That’s what Riddell, the country’s largest [...]
Simbex Receives 2013 New Hampshire Excellence AwardSeptember 10, 2013Simbex LLC has been selected for the 2013 New Hampshire Excellence Award amongst all its peers and competitors [...]
New Partnership to Accelerate Commercialization of Pediatric TechnologiesJuly 5, 2013The New England Pediatric Device Consortium (NEPDC), a non-profit research and education foundation aimed at [...]
Simbex is recognized in 2012 Inc 5000 ListAugust 21, 2012Simbex is recognized for it‘s strong year‐over‐year growth on the 2012 Inc 5000 List.
Ratings for Football Helmets Help Improve Player SafetyMarch 4, 2012Over the last decade or so, researchers have worked tirelessly to zero in on just what happens to a player’s [...]
Simbex HITS featured in Sports Imperative: Protecting Young BrainsAugust 30, 2009In an effort to alert coaches and trainers to a head hit warranting investigation, players at several colleges [...]
Simbex Featured in New York TimesOctober 7, 2007Simbex has developed a tiny accelerometer that fits inside helmet padding, measures sudden movements of the [...]
A Helmet That Detects Hard HitsSeptember 30, 2007There is a growing awareness that football players, from the high-school to the professional level, can suffer [...]
