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

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

April 21, 2017 By Danielle Kirsh

sitting on rock in canyon
[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.

Filed Under: 510(k), Clinical Trials, Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Clearflow, Condor, Getinge, Life Spine, Lifetrack Medical, Mayo Clinic, Monitored Therapeutics, Owlstone Medical, physiocontrol, Remedent

In case you missed it

  • ResMed expects steady growth over the next year
  • Ambu is letting go of 200 employees
  • Medtronic has Class I recall for low-shock risk in ICDs
  • Titan Medical to start manufacturing Enos systems later this year
  • ZimVie sales down more than 11% in Q2 as it streamlines after spinoff
  • Cardinal Health’s CFO to move up to corner office
  • Levita Magnetics raises $26M for Magnetic-Assisted Robotic Surgery platform
  • Data supports use of Channel Medsystems Cerene cryotherapy
  • The 10 largest orthopedic device companies in the world
  • Nanopath raises $10M Series A for women’s health diagnostics
  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy
  • NuVasive chief commercial officer Massimo Calafiore is stepping down
  • Preparing your medical device company for challenging market conditions
  • Dentsply Sirona replaces chief accounting officer amid internal investigation
  • Haemonetics stock rises on Street-beating Q1, raised guidance
  • Surgalign settles on OEM business sale, posts Q2 earnings miss
  • Alcon lowers its 2022 forecast amid strong dollar

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