7 medtech stories we missed this week: April 6, 2018

April 6, 2018 By Danielle Kirsh

[Image from unsplash.com]

From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning.

1. CHF inks Spanish distribution deal

CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow Dimedix Surgical to distribute the CHF’s Aquadex FlexFlow System throughout Spain. The financial terms of the agreement were not disclosed.

2. J&J launches digital surgical training subscription service

J&J has launched a new digital learning platform that gives hospitals and surgeons the ability to assess and enhance technical skills in robotics, laparoscopic and open surgery to improve outcomes and reduce costs, according to an April 5 press release. The platform, known as C-SATS, was created by a team of surgeons, engineers and biostatisticians at the University of Washington and is subscription-based. Surgeons can upload surgical videos to be assessed by expert surgeons and trained reviewers who can give feedback based on technical skills. The skill levels can then be tracked over time.

3. Nanovibronix inks Canadian distribution deal for UroShield

Nanovibronix announced in an April 5 press release that it has signed an exclusive distribution deal with Instrumed Surgical to distribute its UroShield products in Canada. UroShield uses ultrasound to prevent bacterial colonization and biofilm on indwelling urinary catheters while also increasing antibiotic efficiency. The device is designed to reduce the amount of catheter-associated urinary tract infections and decrease pain and discomfort associated with urinary catheter use.

4. FDA expands indication for Asahi Intecc’s Corsair microcaths and coronary guidewires

The FDA has recently expanded indication for Asahi Intecc’s Corsair, Corsair Pro Microcatheters and coronary guide wires, according to a March 28 press release. The new indication includes the company’s Miraclebros series, Confianza series, Fielder series and Gaia series. Asahi Intecc’s devices are designed to treat chronic total occlusion in a minimally-invasive way.

5. Biotronik to distribute Aziyo’s CanGaroo CRM implant envelopes

Biotronik announced in an April 3 press release that it has become the distributor of Aziyo’s CanGaroo extracellular matrix (ECM) cardiovascular implantable electronic device envelopes in the U.S. The BioEnvelope will be available through Biotronik starting in April. BioEnvelope is designed to reduce scar formation and reduce the risk of device migration and erosion. It features a unique ECM material that is a flexible bioscaffold that remodels in three to six months while allowed the body to regrow and restore functional, vascularized tissue naturally.

6. HyperMed wins CE Mark for HyperView imager

HyperMed has received CE Mark approval for its HyperView medical imaging system, according to an April 2 press release. The approval allows the company to distribute its system in Europe. The HyperView System is a fast, handheld, battery operated, non-invasive and portable diagnostic imaging device that is used to identify tissue oxygenation without coming in contact with a patient. Its technology captures a diagnostic image that shows oxyhemoglobin levels, deoxyhemoglobin levels and oxygen saturation in superficial tissue.

7. Guided Therapeutics inks Turkish licensing deal

Guided Therapeutics announced in an April 2 press release that it has signed a Turkish license agreement with ITEM to manufacture its single-patient-use Cervical Guides in Turkey. The agreement gives Guided Therapeutics fees totaling $1.1 million throughout 2018, with the first payment due before April 15. ITEM will pay a royalty for each Cervical Guide it makes and sells in Turkey and will be obligated to buy 540 LuViva Advanced Cervical Scans and make 3,450,000 Cervical Guides in the Turkish market over the next 12 years.

Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA… […]
Raumedic supplies adhesive for production of thousands of ventilators
When the federal government tapped Hamilton Medical to produce tens of thousands of ventilators for COVID-19 patients, the company turned to its long-term partner Raumedic for a special silicone adhesive. The adhesive is solvent- and plasticizer-free, easy to use and bonds silicones to each other and to other materials, such as metal or plastics, according… […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories. The… […]
Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
Medtronic execs see quick recovery, increased M&A
If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]