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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.
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