Medtech stories we missed this week: Nov. 17, 2017

From Skyline Medical’s joint venture to Lensar receiving FDA clearance and CE Mark, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Skyline Medical launches JV deal with Helomics Skyline Medical announced in a Nov. 15 press release that it has signed a joint venture agreement with Helomics.

A $10 microchip helps create 3D ultrasound images: Here’s how

Researchers have used the same accelerometer technology that comes in a smartphone to give $50,000 ultrasound machines 3D imaging capabilities using a $10 microchip. A team of doctors and engineers at Duke University and Stanford University have used a fingernail-sized microchip that is mounted on a traditional ultrasound probe to relay 2D images of what

3 keys to a higher value launch for IVD

Amanda Brantner, Ximedica Launching a new IVD technology can involve many hurdles and risks, but investment dollars abound for technologies that can demonstrate significant value in the healthcare market. “Investment and fundraising in the healthcare ecosystem saw a banner first half of 2017, driven in part by advancements in artificial intelligence and machine learning for

Better medtech UDI management could be an app away

Boston-based 121nexus said it can solve UDI supply chain master data problems through image recognition technology. Experts say the best apps on the market are “peace of mind” apps. 121nexus aims to deliver that feeling with its scanner. The company launched a free scan app that can verify and “open up” GS1 and unique device

How to collaborate better with a product design firm

There are a number of things that medical device companies can do to ensure that their partnerships result in well-designed devices. Here are a few tips for successfully navigating a partnership with a product design firm. Sonja Takatori, Product Creation Studio So you’ve successfully interviewed, evaluated and selected a design firm to partner with on

Bigfoot Biomedical CEO hits back against CMS over data-sharing decision

Bigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move. Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has […]

How DarioHealth turned the smartphone into a user-friendly glucose monitor

When DarioHealth (NSDQ:DRIO) CEO Erez Raphael looks at the medical device world, he sees solutions that were designed by healthcare professionals and doctors – and this presents a stark contrast with the consumer device industry, he pointed out. “We have seen there are a lot of cases, most of the cases in the industry, where the […]

Comparing EO and VPA sterilization

As medtech advances, device makers need to consider sterilization methods that won’t compromise electronics, drugs or biologics. Matt Conlon, Revox Sterilization Solutions The medical device industry has undergone an impressive transformation over the last several years, resulting in new and innovative devices and solutions. As companies continue to innovate, they are finding that commonly used sterilization

How to work with a preclinical contract research organization

When outsourcing medical device laboratory testing, knowing what the regulatory and business requirements are up front is critical to the success of your testing program. Amy A. Schade, Felice Randi LaMadeleine and J. Heléne Andersson, Toxikon Requests such as unusual application of technical or regulatory guidelines, shortened timelines, nonstandard study designs and custom reports are

Simplifying product testing and validation with fastener torque auditing

Capturing data during a product’s manufacturing process can help ensure the quality and consistency of that product. Here’s how that process plays out with fastener torque. Thomas Moore, Futek One of the scariest phases of product design is testing & validation. That’s when any unknown flaws or manufacturing defects will see the light of day.

How to select sterile barrier systems for reusable medical devices

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Jason Pope, Nelson Labs Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the healthcare facility. Often, the

These 5 surgical startups want to build the OR of the future

As with most medtech advances these days, a running theme among top surgical startups is value. Innovators presented their surgical platform products in various stages of development at this year’s AdvaMed MedTech Conference as part of the Medtech Innovator Program, offering a view of the future of ORs across the world. As mentioned, there are some running

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FDA approves first pill with sensor to track ingestion

The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken. The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an […]

Avinger slashes jobs, Q3 sales down 61%

Avinger (Nasdaq:AVGR) – maker of the Lumivascular image-guided, catheter-based system to treat peripheral artery disease (PAD) – continued to experience declining sales as it retrenched during the third quarter, according to its newest earnings report. The Redwood, Calif.–based company has been cutting jobs and other costs – and focusing on existing accounts and winning FDA clearance

Medtronic is closer to VenaSeal coverage: Here’s how

Medtronic is touting its new CPT codes for the VenaSeal varicose vein closure device – codes that company officials think bring the device closer to positive coverage from public and private insurers in the U.S. CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F)