Combination Products

J&J MedTech Keeps Up Cardiovascular Momentum With Shockwave E8 Launch In US

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

Six Deaths linked To Inari Clot Removal Device

 

Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.

Insulet First To Market With Automated Insulin Delivery For Type 2 Diabetes

 
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The Acton, MA-based tubeless insulin pump specialist expands its indication for the Omnipod 5 AID system beyond type 1 diabetes as FDA authorization for type 2 comes sooner than Wall Street expected. Analysts expect clearances of rival systems from Tandem Diabetes Care and Medtronic in 2025, but believe Insulet is well-positioned to compete.


EU Needs Feedback On Draft Requirements For Seven High-Risk IVD Test Categories

 

Two years after the EU adopted the original common specifications for certain products under the IVD Regulation, the commission has added new products and updated its requirements.

News We’re Watching: AMP Sues FDA To Block Lab-Developed Test Rule; FDA Guidances; ICU Medical Infusion Pump Correction

 
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This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

FDA Drops Draft Guidance on Predetermined Change Control Plans for Medical Devices

 

The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.

Hello Heart Says Update To Cardiovascular Health Tracker Could Benefit Women Especially

 
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Hello Heart has introduced a symptom tracking feature in its app, allowing users to log feelings of dizziness or shortness of breath in conjunction with blood pressure readings. The enhancement will help all users to monitor cardiovascular risks, but women in particular could benefit, the company suggests.


Know Labs Making Strides With Non-Invasive CGM For Diabetes Screening

 
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The Seattle-WA-based company’s latest capital raise follows study results published in July in which Know Labs’ proprietary non-invasive RF dielectric sensor and machine learning algorithms correctly classified participants’ glycemic status as hyperglycemic, normoglycemic, or hypoglycemic with 93.37% accuracy compared with venous blood glucose values. Know Labs' goal is to commercialize a diabetes screening device that could help to funnel undiagnosed patients into the health care system.

Baxter Ready To Offload Kidney Care Unit

 
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Global investment firm Carlyle has agreed to pay $3.8b for Baxter International’s Kidney Care unit. The newly spun-off business will be known as Vantive.

Q&A Guidance Doc Dives Into Combination Product User Fees

 
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The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.

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 Offers Draft Guidance For Developers Of Drug Delivery Devices

 

The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.

ADDF Leaders Discuss Future Strategies In Alzheimer’s Research And Crucial Role Of Diagnostic Markers

 
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Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.

EMA Answers More Questions For Manufacturers of Drug-Device Combos

 

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Senseonics Wins Marketing Authorization For Novel Insulin Delivery System

 

The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.


News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR

 
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This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

eXeX Claims ‘World First’: Apple’s Mixed-Reality Headset Deployed As Logistics Tool In OR

 
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The Apple Vision Pro mixed reality headset was used during several spine reconstruction surgeries along with surgical support software and mixed reality provided by eXpanded eXistence, the Orlando, FL-based startup announced on 6 February.

Software Glitch Behind Recalled App Could Drastically Increase Insulin Delivery

 

Insulet Corporation has recalled its Omnipod 5 App for Android smartphones due to a software error that could throw off the accuracy of insulin dosing by as much as one hundred times the intended amount.

FDA Evaluating Safety Of Plastic Syringes From China, May Prevent Their Import To The US

 

The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.