MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » 7 medtech stories we missed this week: Sept. 22, 2017

7 medtech stories we missed this week: Sept. 22, 2017

By

medtech missed
[Image from unsplash.com]
From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. FDA clears Covalon’s MediClear OTC surgical film-drape

Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion site. The film-drape helps protect the patient from bacteria, yeast and viruses. It can be applied by the patient or by clinicians at a consultation prior to surgical procedures. It is then removed immediately before surgery by a clinician in the operating room under sterile conditions.

2. ManaMed launches PlasmaFlow deep vein thrombosis prevention system

ManaMed has launched the first FDA-approved digital and tubeless deep vein thrombosis prevention device, according to a Sept. 21 press release. The deep vein thrombosis prevention device, known as PlasmaFlow, is now available to medical practitioners in the U.S. PlasmaFlow is portable and tubeless with multiple pressure functions. It features a one-button operation, soft cuffs made of a high-grade medical material, 10 hours of rechargeable battery life and two LCD screen with a timer and pressure. It can be used at home or in the hospital to prevent deep vein thrombosis from occurring by stimulating blood flow.

3. Medovex launches DenerveX in Spain

Medovex announced in a Sept. 19 press release that it has launched its DenerveX System in Spain through distributor Prim SA. The DenerveX System denervates and removes capsular tissue from the facet joint during a single procedure. A slowly rotating burr removes targeted facet joint synovial membrane and joint surface as heat ablation destroys tissue and denudes leftover nervous and synovial membrane left on the joint.

4. Getinge and Contego ink European distribution deal

Getinge and Contego have signed a distribution deal stating that Getinge will distribute Contego’s products throughout Europe, according to a Sept. 18 press release. Getinge is set to distribute Contego’s Paladin Carotid Post-Dilation Balloon System and Vanguard IEPTM Peripheral Balloon Angioplasty System, both with integrated embolic protection, in Germany, France, Spain, Portugal, the U.K., Netherlands, Belgium, Austria and Scandinavia.

5. Guerbet gets CE Mark for Victorio chemo mixing system

Guerbet announced in a Sept. 14 press release that its conventional Trans-Arterial Chemo-Embolization (cTACE) mixing and injection system has received CE Mark. The system, known as Vectorio, is a set of Lipiodol resistant medical devices like syringes, stopcock and sampling devices. It is used for mixing and delivery Lipiodol Ultra Fluid and anticancer drugs during cTACE procedures in adults.

6. IBA releases Razor Nano ionization chamber

Ion Beam Applications (IBA) has released its Razor Nano Chamber, according to a Sept. 20 press release. The Nano Chamber is one of the smallest available ionization chambers available on the market. It is a waterproof, ventilated small ionization chamber that has long-term stability and a small diameter of 2 mm.

7. Bioventus launches Exogen study

Bioventus announced in a Sept. 13 press release that it has launched its BONES program and has enrolled its first patients in the study. The BONES program (Bioventus Observational Non-interventional Exogen Studies) is designed to collect data on the use of the Exogen Ultrasound Bone Healing System that uses safe, effective, low-intensity pulsed ultrasound to stimulate the natural bone healing process.

Here’s what we missed last week.

In case you missed it

RSS From Medical Design & Outsourcing

  • FDA will review fewer COVID-19 test EUA submissions
    The FDA is pushing COVID-19 test developers away from emergency use authorization (EUA) submissions in favor of more traditional pathways, the agency said today. The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review… […]
  • Integra plans to shrink the C-suite after executive’s exit
    Integra Lifesciences (Nasdaq: IART) will eliminate the position of chief operating officer next week — though the office is already empty. Former COO Glenn Coleman’s last day at Integra was Friday, according to a separation agreement filed with the Securities and Exchange Commission that same day. Coleman was scheduled to start as the new EVP and… […]
  • Steris plans to build a new medical device testing facility
    Steris (NYSE: STE) plans to build a new packaging and microbiological testing facility for medical devices in Leipzig, Germany. The facility will offer packaging testing services such as accelerated and real-time aging, transportation and integrity testing. The new location will also offer microbiological testing in collaboration with the medical device manufacturer and sterilizer’s laboratory in… […]
  • 10 medical device startups you need to know
    Some of the most interesting medical device startups of 2022 are advancing a wide range of innovative medtech: robotics, catheter-delivered brain-computer interfaces and more. The editors here at Medical Design & Outsourcing and MassDevice are writing about medical device startups all the time. But there are some device companies starting out that have technologies that… […]
  • Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuits
    Steris (NYSE: STE) stock was downgraded today by Needham from buy to hold following the $363 million jury verdict against its primary competitor, Sterigenics, over ethylene oxide (EtO) emissions. Needham analysts said they expect attorneys to target communities near EtO facilities with ads to find people willing to file more lawsuits against sterilization plant operators… […]
  • Researchers develop at-home device to track Parkinson’s progression
    Researchers at MIT and the University of Rochester Medical Center have developed a device to monitor a Parkinson’s patient at home. Collecting data at home could help provide a less subjective measurement than evaluations at the doctor’s office, which can be affected by outside factors. The technology could also help pharmaceutical and biotech companies developing… […]
  • Micro Mold renovates for new 5-axis milling center
    Precision mold maker Micro Mold has renovated in Erie, Pennsylvania, to make room for its new Yasda YMC650 high-speed 5-axis milling center and 3R Workpartner automation cell. The new equipment will be used for electrode manufacturing and finishing hard mill applications. The milling machine is accurate to 1 micron for high-volume, ultra-precision tooling work, the… […]
  • September 2022 Issue: The Medtech Big 100 is bigger than ever
    Medtech sales reach a record high as R&D spend and employee counts climb Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future Autotransfusion device maker ships units to Ukraine How IP protection is enabling robotic surgery innovation Connected device design for the real world: Managing the development process FDA details plans to expand… […]
  • How NeuroOne and Zimmer Biomet will partner on robotic brain surgery
    NeuroOne (NASDAQ: NMTC) is preparing its depth electrode technology for commercialization through Zimmer Biomet (NYSE: ZBH) while waiting for FDA feedback on its latest submission. NeuroOne’s Evo stereoelectroencephalography (sEEG) device won FDA 510(k) clearance in September 2021 for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. That clearance was… […]
  • Trelleborg to show off advanced polymer tech at MD&M Minneapolis
    Trelleborg Healthcare & Medical will exhibit advanced polymer technologies for medical applications at MD&M Minneapolis, which runs Nov. 2–3, 2022. The Sweden-based engineering polymer giant, which has operations in 50 companies, has newly acquired, advanced capabilities in thermoplastic injection molding. The new injection molding capabilities come from its purchase of Menomonie, Wisconsin–based EirMed earlier this… […]
  • Millstone Medical Outsourcing expands cleanroom facility
    Millstone Medical Outsourcing said today that it has broken ground on a 5,000-square-foot cleanroom facility expansion at its Fall River, Massachusetts headquarters. The project is Millstone’s third cleanroom expansion. The additional Class 10,000/ISO7-rated cleanroom space is for medical device packaging operations. It will bring the company’s total cleanroom footprint to 20,000 square feet. Responding to… […]