7 medtech stories we missed this week: April 21, 2017

April 21, 2017 By Danielle Kirsh

[Image from unsplash.com]

From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. Life Spine receives FDA clearance for cervical spacer system

Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses Life Spine’s titanium surface technology, Osseo-Loc, that helps with potential bone growth. Plateau-C Ti also has additional graft windows to help with visibility in-situ and bone graft containment. It entered full-market release on April 3 this year.

2. Lifetrack Medical announces FDA approval for PACS for distributed radiology

Lifetrack Medical Systems announced the FDA approval of its LifeSys PACS for distributed radiology, according to an April 19 press release. Its platform is designed to expand the availability of high-quality medicine and simplify and speed the development of digital radiology while reducing costs and bringing high-quality diagnostic reporting to large populations who need it. The PACS system features patented RadNav technology that serves as a guidance system to radiologists through its decision support system and templates.

3. Physio-Control launches HeartSine samaritan 360p AED

Physio-Control announced in an April 19 press release that its HeartSine samaritan PAD 36op AED is now available in the U.S. after receiving FDA pre-market approval. The HeartSine samaritan PAD 360P measures cardiac rhythm and automatically delivers a shock to someone who has a sudden cardiac arrest to restore the heart to normal rhythm. The AED is user-friendly and provides easy-to-follow visual and audio prompts. If the system finds that a person needs shock delivery, it will deliver it automatically without the need for pressing a button.

4. Owlstone Medical, Mayo Clinic to develop colonoscopy evaluation tool

Owlstone Medical and Mayo Clinic announced a partnership in an April 19 press release. The two companies are developing a pre-endoscopic test to improve the effectiveness of colonoscopy tests. Owlstone’s FAMIS technology is currently in a clinical trial to evaluate how it performs as a rapid, point-of-care test to non-invasively assess the adequacy of bowel preparation prior to colonoscopy. Pilot study results showed that the company’s technology is able to rapidly and effectively identify patients who are not properly prepped for colonoscopy with 100% sensitivity and 80% specificity.

5. FDA clears first wireless home spirometer

Monitored Therapeutics announced in an April 18 press release that it has received FDA 510(k) clearance for its GoSpiro home spirometer, which is the first spirometer designed for at-home wireless use. It is designed to work with a variety of smartphones, tablets and PCs. It gathers diagnostic quality forced spirometry and slow spirometry with the same accuracy as hospital laboratory systems and can give immediate feedback to patients on the quality of their test performance.

6. Remedent and Condor ink dental distribution deal

Remedent announced that it has entered a distribution deal with Condor to launch and distribute its 3D dental scanner in North America, according to an April 10 press release. Condor specializes in dental CAD/CAM equipment. Remedent has started hiring the appropriate staff to bring Condor’s new oral scanner to market.

7. Clearflow and Getinge announce partnership renewal

Clearflow and Getinge have announced in an April 10 press release that they have decided to renew their partnership to promote the PleuraFlow Active Clearance Technology System. The strategic partnership involves selling the system in the U.S. to enhance the clinical and economic value proposition.

Here’s what we missed last week.

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… […]