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FDA Will No Longer Regulate Certain Medical Software
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
Prescience Point Capital Launches Proxy Fight To Change MiMedx's Board
Prescience Point Capital is trying to reshuffle the board of directors leading regenerative medicine company MiMedx, arguing the company’s current board has destroyed shareholder value. The company's tock is selling for about a third of its potential value, according to Prescience.
Submitting A Non-COVID-19 Product For FDA Review? Then Take A Seat, It’s Gonna Be Awhile
Top US FDA device center officials Jeff Shuren and William Maisel said in a 15 April blog post that manufacturers should expect a delay in the review of new product submissions thanks to the pandemic. They noted that the agency also won’t be accepting certain IVD pre-submission requests until next year.
Turkish Medtechs Face The Constant Challenge Of Sailing In Stormy Seas
The pandemic has exacerbated the problems of the Turkish medical device industry, which was already struggling for survival and growth in a hostile policy environment. Local blood bag manufacturer Kansuk Laboratory talked to Medtech Insight about the difficulties it faces.
Spotlight On Case Studies
Lucira Health’s Unexpected Sprint To A First-Of-Its-Kind EUA From FDA: The Inside Story
Lucira Health executive VP Kelly Brezoczky explains in this Medtech Insight case study how the company shifted gears from making a test for influenza A and B to quickly developing one that detected SARS-CoV-2. The result was the company’s COVID-19 All-In-One Test Kit, an at-home prescription molecular diagnostic test that was the first of its type to hit the market when the US FDA granted it emergency use authorization last November.
Securing FDA Approval For Novel OPRA Prosthetic Wasn’t A ‘Slam Dunk.’ Here’s How Start-Up Integrum Made It Through The PMA Maze
Ellume CEO Ponders Future Of Company’s Rapid COVID-19 Antigen Test
Device Week, 9 April 2021 – A Look At The EUA Process For Lucira Health, Ellume COVID-19 Tests
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
Facts And Figures Show It Is Essential To Better Manage The EU IVDR Peak: But How?
No one should underestimate the scale of the obstacles companies face trying to comply in time with the IVD Regulation by its 26 May 2022 deadline, especially now data is starting to emerge to highlight the size of the problem.
US FDA: Recall Of BD Alaris Infusion Pump Is High-Risk Class I
Becton Dickinson’s CareFusion 303 Inc. subsidiary recalled 145,492 of the pumps because there’s a risk that the device’s keypad will lift up and away from the device body if it comes into contact with fluids.
US FDA Nukes HHS Decision To Exempt Medical Gloves, Other Products From Regulatory Oversight
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.
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12 Deaths Prompt Another Class I Recall For Medtronic’s HeartWare – The Firm’s Fourth In Recent Weeks
The medtech giant has racked up yet another high-risk class I recall designation from the US FDA, this time for HeartWare Ventricular Assist Device (HVAD) cables and controller ports. It’s also the second class I recall action for the HeartWare device in a little more than six weeks, and the company’s fourth overall.
It’s COVID-19 ‘Clean-Up Time’: FDA, Health Canada Hint At What’s Next In Enforcement
American and Canadian regulators have taken stock of their enforcement activities in the first year of the pandemic, and now they’re focused on what’s coming next.
Latest From Policy & Regulation
US Sen. Duckworth Prods FEMA To Help Overstocked PPE Reach Potential Users
The Illinois senator pointed to an apparent mismatch between ongoing reports of equipment shortages, and alleged stockpiles of unsold masks.
TEAM-NB Highlights Survey Figures Suggesting Massive 2024 Bulge In MDR Applications
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
FDA’s 5 Steps To A Successful ASCA Pilot Submission
Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.
US Lawmakers Reintroduce Bill To Better Patient Access To Prosthetic Devices, Other Limb-Loss Technologies
The bipartisan Triple A Study Act directs the Government Accountability Office to report back to Congress on the coverage of assistive technologies for people with limb loss or limb difference.
Device Week, 14 April 2021 – Mayo Clinic, VHA Big On 3D Printing; Ortho Market
In this week’s podcast, Medtech Insight managing editor Marion Webb discusses plans by the Mayo Clinic and Veterans Health Administration to position themselves as medical device makers of 3D-printing technologies. UK-based reporter Barnaby Pickering gives an overview of global market for arthroscopy and sports medicine products.
FDA Authorizes GI Genius As A Smarter AI-Based Colonoscopy Tool
According to a large clinical study, the first such device with AI-enabled software is better at detecting potential lesions than traditional colonoscopies and could allow detection of colon cancer sooner.
Quality Control & Compliance Explore this Topic
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Latest From Quality Control
TEAM-NB Highlights Survey Figures Suggesting Massive 2024 Bulge In MDR Applications
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
Another Class I Recall For Medtronic, This Time For Defibrillators
The US FDA on 12 April affixed its highest risk classification to a recall of certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) made by Medtronic. It’s the third class I recall for the medtech giant since 1 March.
FDA Plans To Improve COVID-19 EUA Process, Inspection Work Based On Report Recommendation
The agency is taking to heart several recommendations made by an independent reviewer earlier this year in a report on its COVID-19 response.
OUTLOOK 2021
Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings
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Surgical Robotics Company Vicarious Surgical To Merge With D8 SPAC In $1.1Bn Deal
Vicarious Surgical, whose medical robot received US FDA breakthrough designation, announced it will merge with D8 Holdings Corp. The deal is expected to garner up to $460m.
Latest From Commercial
Execs On The Move: Repro-Med Replaces Its CEO
At Repro-Med, James Beck has been replaced by Linda Tharby as CEO, and more.
Mayo Clinic Launches Two Companies To Support New Remote Monitoring Initiative
The Minnesota-based health care system announced the formation of Anumana Inc. to commercialize artificial intelligence-enabled algorithms and Lucem Health to curate data collected from remote monitoring devices.
MD&M BIOMEDigital 2021: Wearables – Where Are They Headed?
As wearable medical devices become increasingly common for more and more complex applications, developers are facing questions are about the industry’s direction and how they will protect consumers.
Device Week, 14 April 2021 – Mayo Clinic, VHA Big On 3D Printing; Ortho Market
In this week’s podcast, Medtech Insight managing editor Marion Webb discusses plans by the Mayo Clinic and Veterans Health Administration to position themselves as medical device makers of 3D-printing technologies. UK-based reporter Barnaby Pickering gives an overview of global market for arthroscopy and sports medicine products.
Luminex Will Be Acquired By DiaSorin For About $1.8Bn
The buyout will broaden DiaSorin’s positioning in the fast-growing molecular diagnostics space and expand Luminex’s foothold outside the US.
Reimbursement Dispute Between Novitas And iRhythm Hits An Impasse
Local Medicare carrier Novitas raised its reimbursement rates for continuous cardiac monitoring, but iRhythm has concluded the rates are still too low and is preparing to discontinue serving this Medicare segment.
Clinical R&D Explore this Topic
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Start-Up Spotlight: Pre Diagnostics Picks Up Momentum In Early Neurodegenerative Disease Detection
Norway’s Pre Diagnostics uses the intracellular approach to neurodegenerative disease diagnosis. It believes its technology will open up a world of precision medicine for Alzheimer’s disease patients.
Latest From Research & Development
Mayo Clinic Launches Two Companies To Support New Remote Monitoring Initiative
The Minnesota-based health care system announced the formation of Anumana Inc. to commercialize artificial intelligence-enabled algorithms and Lucem Health to curate data collected from remote monitoring devices.
FDA’s 5 Steps To A Successful ASCA Pilot Submission
Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.
MD&M BIOMEDigital 2021: Wearables – Where Are They Headed?
As wearable medical devices become increasingly common for more and more complex applications, developers are facing questions are about the industry’s direction and how they will protect consumers.
Luminex Will Be Acquired By DiaSorin For About $1.8Bn
The buyout will broaden DiaSorin’s positioning in the fast-growing molecular diagnostics space and expand Luminex’s foothold outside the US.
FDA Authorizes GI Genius As A Smarter AI-Based Colonoscopy Tool
According to a large clinical study, the first such device with AI-enabled software is better at detecting potential lesions than traditional colonoscopies and could allow detection of colon cancer sooner.
Italian Orthopedics Company Greenbone OrthoSpA Raises €10M In Series B
Greenbone will use the proceeds to launch its CE-marked bone regeneration scaffold and plans to file for 510(k) FDA clearance.
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